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Posts Tagged ‘Food and Drug Administration’

FDA Alert – Drug Safety Communication: Multaq (dronedarone) – Increased Risk of Death or Serious Cardiovascular Events

Posted by 4love2love on July 24, 2011

July 21, 2011

ISSUE
: FDA notified healthcareprofessionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation. The study was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo. FDA is evaluating whether and how the preliminary results of the PALLAS study apply to patients taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter. The PALLAS study results are considered preliminary at this time because the data have not undergone quality assurance procedures and have not been completely adjudicated. FDA will update the public when more information is available.

BACKGROUND: Multaq is approved for use to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

RECOMMENDATION: At this time, patients taking Multaq should talk to their healthcareprofessional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation. See the Data Summary in the Drug Safety Communication for additional details.

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FDA Alert – Drug Safety Communication: Oral Osteoporosis Drugs (bisphosphonates) – Potential Increased Risk of Esophageal Cancer

Posted by 4love2love on July 24, 2011

July 21, 2011
Includes: Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate)

ISSUE: FDA notified healthcare professionalsand patients about its ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer. There are insufficient data to recommend endoscopic screening of asymptomatic patients. FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available.

BACKGROUND: Oral bisphosphonates are commonly used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget’s disease. There have been conflicting findings from studies evaluating the risk of esophageal cancer. Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates. See the Data Summary in the Drug Safety Communication for additional details.

RECOMMENDATION: Patients should talk with their healthcare professional about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them. Patients should talk with their healthcare professional if they develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing. Patients should be instructed to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA Alert – Drug Safety Communication: CardioGen-82 PET Scan – Increased Radiation Exposure

Posted by 4love2love on July 24, 2011

July 15, 2011

ISSUE:
 FDA notified the public and the medical imaging community about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82 manufactured by Bracco Diagnostics, Inc.

BACKGROUND: A CardioGen-82 PET scan is one of a variety of nuclear medicine scans and uses the radioactive drug Rb-82 chloride injection to evaluate the heart. FDA has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was due to strontium isotopes which may have been inadvertently injected into the patients due to a “strontium breakthrough” problem with CardioGen-82.

RECOMMENDATION: At this time, FDA believes that the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable. The estimated amount of excess radiation the two patients received is similar to that other patients may receive with cumulative exposure to certain other types of heart scans. It would take much more radiation to cause any severe adverse health effects in patients.

Healthcare professionals should closely follow the required testing and quality control procedures essential to help detect strontium breakthrough from CardioGen-82. Other types of heart scans provide information very similar to CardioGen-82 and professionals are encouraged to consider these alternatives while FDA completes its investigation of the reported cases of excess radiation exposure.

Patients who have recently had heart scans should talk to their healthcare professional if they have any questions. Patients who are planning to undergo a heart scan should talk to the healthcare professional if they are unsure of the type of planned heart scan and the radiation risks associated with the scan.

FDA is actively investigating the root cause of this failure with CardioGen-82 and will promptly notify the public with updates.

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FDA Alert – Label Change: Tamiflu (oseltamivir phosphate) for Oral Suspension – New Concentration (6 mg/mL)

Posted by 4love2love on July 24, 2011

July 11, 2011
Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).

ISSUE: Labeling changes are being made to Tamiflu oral suspension to reduce the possibility of prescribing and dosing confusion that can lead to medication errors.  The changes to the product label include:

  • A change in the concentration of Tamiflu from 12 mg/mL to 6 mg/mL. The lower concentration of Tamiflu is less likely to become frothy when shaken, which helps to ensure an accurate measurement. A change in the measurements of the oral dosing device from milligrams (mg = weight) to milliliters (mL = volume).
  • A change in the dosing table for Tamiflu to include a column for the volume (mL) based on the new 6 mg/mL concentration. Revised container labels and carton packaging. Revised compounding instructions for pharmacies to prepare a 6 mg/mL oral suspension from Tamiflu capsules in an emergency situation only if the commercially manufactured Tamiflu for oral suspension is unavailable.

BACKGROUND: Tamiflu is in a class of medications called neuraminidase inhibitors. These drugs work by stopping the spread of the influenza (flu) virus in the body. Genentech, the manufacturer of Tamiflu for oral suspension, plans to begin distribution of the new 6 mg/mL product in July 2011.  The company has instituted a voluntary Take Back Program for wholesale buyers, distributors and pharmacies to remove the 12 mg/mL product from the marketplace. The 12 mg/mL product will remain in the marketplace and in state or national stockpiles until current supplies expire.

RECOMMENDATION: It is important for healthcare professionals to be aware that a patient may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). Steps should be taken to avoid the potential for a medication error due to confusion between the two concentrations. Prescribers should include the new concentration (6 mg/mL) and dose in milliliters on all prescriptions for Tamiflu for oral suspension.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA Alert – Public Notification: Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules – Undeclared Drug Ingredient

Posted by 4love2love on July 24, 2011

July 8, 2011

ISSUE
: FDA is advising consumers not to purchase or use Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules. FDA laboratory analysis confirmed that these products contain sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking.

BACKGROUND: Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules are products marketed for weight loss, sold on various websites and distributed by LA Beauty Store, Inc. This notification is to inform the public of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.

RECOMMENDATION: Consumers should stop using these products immediately and throw them away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/08/2011 – Public Notification – FDA]

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FDA Alert – Risk Evaluation and Mitigation Strategy (REMS): Nulojix (belatacept)

Posted by 4love2love on July 24, 2011

July 7, 2011
Increased Risk of Post-transplant Lymphoproliferative Disorder (PTLD), predominantly involving the Central Nervous System (CNS), and Progressive Multifocal Leukoencephalopathy (PML)

ISSUE: Bristol-Myers Squibb informed healthcare professionals about the REMS that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of PTLD and PML, both of which can be fatal. Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the CNS. PML has been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen.

BACKGROUND: FDA may require a REMS from a manufacturer before approval or post approval to ensure that the benefits of a drug or biological product outweigh its risks. Nulojix is a selective T-cell costimulation blocker recently approved for prophylaxis of organ rejection in adult patients receiving a kidney transplant. Nulojix is to be used in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. Nulojix is indicated for use only in transplant patients who are Epstein-Barr virus (EBV) seropositive. Use in liver transplant patients is not recommended due to an increased risk of graft loss and death. Use of Nulojix for the prophylaxis of organ rejection in other transplanted organs has not been established.

RECOMMENDATION: Be sure to verify the patient’s EBV status before initiating therapy with Nulojix. BMS established the ENLiST Registry to further evaluate the safety profile of Nulojix. BMS encourages your participation in the ENLiST Registry.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[June 2011 – Healthcare Professional Letter – Bristol-Myers Squibb]

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FDA Alert – Drug Safety Communication: Valproate Products – Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

Posted by 4love2love on July 24, 2011

June 30, 2011
Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics

ISSUE: FDA notified healthcare professionalsthat children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy. See the Drug Safety Communication for a data summary and additional information.

BACKGROUND: Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.

RECOMMENDATION: Healthcare professionals should inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure, and should continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy. In addition, healthcare professionals should weigh the benefits and risks of valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of adverse birth outcomes should be considered. Patients should not stop taking valproate without talking to a healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA Approves Lazanda – First Fentanyl Nasal Spray – for the Management of Breakthrough Pain in Cancer Patients

Posted by 4love2love on July 24, 2011

FDA Approves Lazanda – First Fentanyl Nasal Spray – for the Management of Breakthrough Pain in Cancer Patients

“Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain,” says Jeffrey H. Buchalter, chief executive officer of Archimedes Pharma. “Lazanda, which uses our patented PecSys® drug delivery system, is designed to deliver medicine in a rapid, but controlled manner, and provides patients with an effective alternative to manage their breakthrough pain.”

Breakthrough pain in cancer (BTPc) is an intense, sudden pain that is often unpredictable and debilitating and occurs despite otherwise appropriate opioid therapy for background pain. BTPc has a different profile from background pain. BTPc often has high intensity, a rapid onset, usually reaching maximum intensity within five minutes, and a short duration, lasting between 30 and 60 minutes per episode. On average, BTPc affects more than half of patients with cancer and often interferes with patients’ health and ability to engage in daily living activities.

“As the first fentanyl nasal spray in the U.S., Lazanda provides a new approach to managing the often debilitating and inadequately-treated episodes of breakthrough pain that many patients with cancer experience,” said Donald Taylor, M.D., director at Taylor Research LLC., and clinical investigator for Lazanda. “Current treatment options typically utilize short-acting oral opioid medications that cannot provide pain relief with an onset of action or duration of effect that matches the time course of a BTPc episode. Lazanda’s rapid and controlled availability is a much better match for the nature of an episode of breakthrough pain, giving physicians a new and powerful tool for treating cancer breakthrough pain.”

Lazanda will be available in the second half of this year through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction, overdose, and serious complications due to medication errors. Under the Lazanda REMS program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to dispense, distribute, and prescribe Lazanda.

“We fully support the FDA mandate to implement a REMS program for Lazanda as an important way to provide patients, healthcare providers, and pharmacists with the information they need about the appropriate and safe use of Lazanda,” said Buchalter. “Archimedes Pharma looks forward to working closely with health care professionals to ensure safe and consistent access to Lazanda for the patients who are seeking relief from unbearable episodes of breakthrough pain in cancer.”

About Lazanda (fentanyl) nasal spray

Lazanda contains fentanyl, which is a Schedule II controlled substance, and uses Archimedes Pharma’s patented drug delivery system, PecSys®.

Lazanda, incorporating PecSys technology, delivers fentanyl in a rapid, but controlled manner and is designed to deliver a fine mist spray to a mucus membrane, in this case the nasal membrane. Each spray of Lazanda forms a gel when it contacts the nasal mucosa; the active ingredient is then rapidly absorbed across the mucus membrane and directly into the blood stream.

The efficacy of Lazanda for the management of breakthrough pain in adult cancer patients was established in a double-blind, placebo-controlled clinical study in which Lazanda showed a statistically significant improvement compared with placebo on the primary endpoint, the sum of the pain intensity difference at 30 minutes (SPID30). More than 500 patients evaluated in the clinical trial program (which included three phase III clinical trials) contributed to the understanding of the tolerability and safety profile of Lazanda. The most common adverse events associated with Lazanda were consistent with opioid treatment and included vomiting, nausea, pyrexia (fever), and constipation.

Important Safety Information

Warnings: Potential for Abuse and Importance of Proper Patient Selection

Lazanda contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Lazanda can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the potential for abuse when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Schedule II opioid substances, which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Serious adverse events, including deaths, in patients treated with other oral transmucosal fentanyl products have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of Lazanda for any other fentanyl product may result in fatal overdose.

Lazanda is indicated only for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Lazanda is contraindicated in opioid non-tolerant patients and is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products. When prescribing, do not convert patients on a mcg per mcg basis from another fentanyl product to Lazanda. Patients beginning treatment with Lazanda must begin with titration from the 100 mcg dose. (see Dosage and Administration)

When dispensing, do not substitute a Lazanda prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetics of Lazanda compared to other fentanyl products that could result in clinically important differences in the rate and extent of absorption of fentanyl and could result in fatal overdose.

Special care must be used when dosing with Lazanda. If the breakthrough pain episode is not relieved, patients must wait at least 2 hours before taking another dose of Lazanda. (see Dosage and Administration)

Lazanda is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.

Patients and their caregivers must be instructed that Lazanda contains a medicine in an amount that can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. Lazanda must be kept out of the reach of children at all times. (see Patient/Caregiver Instructions)

The concomitant use of Lazanda with cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.

Because of the risk for misuse, abuse, addiction, and overdose, Lazanda is available only through a restricted program, required by the Food and Drug Administration, called the Lazanda REMS (Risk Evaluation and Mitigation Strategy) program. Under the Lazanda REMS program,healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program to prescribe, receive, dispense, and distribute Lazanda, respectively. [see Warnings and Precautions]. Further information is available at http://www.LazandaREMS.com or by calling 1-855-841-4234.

Contraindications

  • Lazanda is contraindicated in the management of pain in opioid non-tolerant patients, because life-threatening hypoventilation could occur at any dose in patients not already taking around-the-clock opioid therapy.
  • Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.
  • Lazanda is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.

Warnings And Precautions

  • Patients must not be converted to Lazanda from other fentanyl products because it is not equivalent to other fentanyl products on a mcg per mcg basis, and such substitution could result in a fatal overdose; do not substitute Lazanda for another fentanyl product when being dispensed.
  • Serious or fatal respiratory depression can occur even at recommended doses in patients using Lazanda. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.
  • Lazanda could be fatal to individuals for whom it is not prescribed and for those who are not opioid tolerant.
  • Patients and their caregivers must be instructed that Lazanda contains medicine in an amount that could be fatal to a child and thus must keep both used and unused bottles in their child-resistant container and out of the reach of children at all times and all residual fentanyl must be emptied before disposal.
  • Patients on concomitant CNS depressants must be monitored for a change in opioid effects and adjust the dose of Lazanda.
  • Concomitant use with potent cytochrome P450 3A4 inhibitors may increase depressant effects including hypoventilation, hypotension, and profound sedation. Monitor and consider dosage adjustment if warranted.
  • Cautiously adjust the dose of Lazanda in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression.
  • Administer Lazanda with extreme caution in patients particularly susceptible to intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
  • Patients taking Lazanda must be warned that opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
  • Use Lazanda with caution in patients with bradyarrhythmias.
  • Lazanda is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Drug Interactions

  • Potential interactions may occur when Lazanda is given concurrently with agents that affect CYP3A4 activity. Monitor patients for signs of opioid toxicity who begin therapy with, or increase the dose of, inhibitors of CYP3A4 or stop therapy with, or decrease the dose of, inducers of CYP3A4.Monitor patients who are taking vasoconstrictive nasal agents to treat allergic rhinitis for potentially impaired pain management.

Use In Specific Populations

  • Safety and efficacy below 18 years of age have not been established.
  • There are no adequate and well-controlled studies of Lazanda in pregnant women. Do not use Lazanda during labor and delivery or in women who are nursing.
  • Lazanda should be administered with caution in patients with impaired renal or hepatic function and titrated to clinical effect in patients with severe renal or hepatic disease.

Adverse Reactions

  • Most common adverse events during titration (frequency greater than or equal to 5%): nausea, vomiting, and dizziness.
  • Most common adverse events during maintenance (frequency greater than or equal to 5%): vomiting, nausea, pyrexia, and constipation.

Please see the accompanying full Prescribing Information including boxed warning. For more information please see http://www.lazanda.com.

About Archimedes Pharma

Archimedes Pharma is an international specialty pharmaceutical company providing novel and advanced treatments to address unmet needs for people living with serious or life-threatening chronic and debilitating illnesses. Archimedes Pharma markets a diverse portfolio of speciality products and has operations in the U.S. and throughout Europe. Archimedes Pharma U.S. Inc. is a subsidiary of Archimedes Pharma Ltd. For more information, please visit: http://www.ArchimedesPharma.com.

Lazanda®, PecFent®, and PecSys® are registered trademarks of Archimedes Development Ltd.

SOURCE Archimedes Pharma Ltd.

Posted: June 2011

Posted in Health & Wellness Information | Tagged: , , , , , , , | 1 Comment »

FDA Alert – Recall: Tylenol Extra Strength Caplets, 225 count bottles – Uncharacteristic Odor

Posted by 4love2love on July 24, 2011

June 29, 2011

ISSUE
: McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recall stems from a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA). While not considered to be toxic, TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.

BACKGROUND: The Tylenol lot ABA619 – which includes 60,912 bottles – was manufactured in February, 2009. The product lot number for the recalled product can be found on the side of the bottle label.

RECOMMENDATION: Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at http://www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA Alert – Recall: Endocet (oxycodone / acetaminophen) Tablets, ( 10mg, 325mg ) – Some Bottles Contain Different Strength Tablets

Posted by 4love2love on July 24, 2011

June 27, 2011
ISSUE: Endo Pharmaceuticals  and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg  because some bottles may contain different strength tablets, resulting in  patients taking more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

BACKGROUND: The affected lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL and TN. These wholesalers may further distribute to other retailers and wholesalers nationwide. Lot numbers can be found on the side of the manufacturer’s bottle. Tablet descriptions and photographs are provided in the firm’s press release.

RECOMMENDATION: Consumers who have the affected product should stop using the product and contact Endo’s agent Stericycle at 1-866-723-2681 for return of the product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA MedWatch Alert – Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication – Modified Dosing Recommendations

Posted by 4love2love on July 24, 2011

June 24, 2011
Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp)

ISSUE: FDA notified healthcare professionalsthat new, modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved to improve the safe use of these drugs. FDA has made these recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.

BACKGROUND: ESAs treat certain types of anemia by stimulating the bone marrow to produce red blood cells and by decreasing the need for blood transfusions. The manufacturer has revised the Boxed Warning, Warnings and Precautions, and Dosage and Administration sections of the labels for the ESAs to include this new information.

RECOMMENDATIONHealthcare professionals should weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions in CKD patients against the increased risks for serious cardiovascular events, and should inform their patients of the current understanding of potential risks and benefits. Therapy should be individualized to the patient and the lowest possible ESA dose given to reduce the need for transfusions. See the Drug Safety Communication for additional information including a table of key trials and other supporting references. Treatment with ESAs in CKD was discussed at the Cardiovascular and Renal Drugs Advisory Committee, held October 18, 2010. For summary minutes of that Advisory Committee, see link below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA Alerts – Recall of Risperdal and Risperidone; FDA Approves Oxecta

Posted by 4love2love on July 24, 2011

Risperdal (risperidone) and Risperidone: Recall – Uncharacteristic Odor

June 20, 2011
ISSUE: Ortho-McNeil-Janssen Pharmaceuticals notified healthcareprofessionals and the public of a recall of specific lots of Risperdal (risperidone) 3mg  tablets and risperidone 2mg tablets. The recall stems from consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored. While not considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms.

BACKGROUND: The Risperdal lot 0GG904 – which includes approximately 16,000 bottles – was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of Risperdal from this lot remaining in the marketplace. The risperidone lot OIG175 – which includes approximately 24,000 bottles – was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace. Risperdal (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years, alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania and is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years.

RECOMMENDATION: Patients should not stop taking their medication. Anyone experiencing an uncharacteristic odor associated with Risperdal  3mg Tablets or risperidone 2mg Tablets should return the tablets to their pharmacist, and contact their healthcare professional if they have questions.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

 

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FDA Approves Oxecta

Pfizer and Acura Announce FDA Approval of Oxecta (Oxycodone HCl, USP) CII

NEW YORK–(BUSINESS WIRE)–Jun 20, 2011 – Pfizer Inc. and Acura Pharmaceuticals Inc. announce the marketing approval from the U.S. Food and Drug Administration (FDA) of Oxecta(oxycodone HCl, USP) Tablets CII. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments. However, abuse and misuse of opioids is a serious public health issue that is the focus of a number of recent United States government initiatives.Oxecta is the first immediate-release oxycodone HCl medicine that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse. This AVERSION Technology is a unique composition of commonly used pharmaceutical ingredients. Pfizer is licensing the technology in Oxecta fromAcura.

“We recognize our responsibility to physicians and patients and remain committed to appropriate access to pain treatment and developing medicines to potentially address this important public health and safety issue,” said Olivier Brandicourt, Pfizer president and general manager, Primary Care. “Oxecta will further expand Pfizer’s presence in pain management and complements our growing, robust portfolio of treatments and medicines in development for pain relief, one of our strategic, high-priority disease areas. We are pleased to bring Oxecta to patients and physicians with our partner Acura.”

“We are excited to be partnered with Pfizer to bring Oxecta to patients who need opioids to manage their pain,” said Robert Jones, interim president and chief executive officer of Acura Pharmaceuticals, Inc. “Acura is focused on developing technologies that are intended to potentially deter abuse and misuse.”

Important Safety Information

Oxecta is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment, in any patient who has or is suspected of having paralytic ileus, in patients with acute or severe bronchial asthma or hypercarbia, and in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product.

Respiratory depression is the primary risk of Oxecta. This is more common in elderly or debilitated patients, in those suffering from conditions such as COPD, severe asthma, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients.

Oxecta contains oxycodone HCl, an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addictions. Oxecta can be abused in a manner similar to other opioids and narcotics. This should be considered when prescribing or dispensing oxycodone HCl in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse. Oxecta may be abused by crushing, chewing, snorting or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death. Oxecta should not be given to anyone other than the individual for whom it was prescribed. Keep Oxecta in a locked cabinet, drawer or medicine safe so that it will not be stolen.

There is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone.

Take each Oxecta tablet with enough water to ensure complete swallowing immediately after placing in the mouth, and Oxecta must be swallowed whole. As Oxecta is not amenable to crushing and dissolution, do not use Oxecta in nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.

Patients who have not been receiving opioid analgesics should start on Oxecta in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their first dose of Oxecta. Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable pain relief and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis. When a patient no longer needs treatment with Oxecta after long-term use, it is important to gradually taper Oxecta over time to prevent withdrawal symptoms.

Patients taking Oxecta in combination with other medicines like sedatives, anesthetics or narcotics may have serious problems such as respiratory depression, low blood pressure, profound sedation, or coma. Do not drink alcoholic beverages or take any medicines containing alcohol while taking Oxecta.

Use Oxecta with caution in patients with head injuries or other conditions that increase pressure in the brain, shock with low blood volume, severe undiagnosed abdominal conditions, history of seizures, severe kidney or liver disease, gall bladder disease, Addison’s disease, hypothyroidism, enlarged prostate or other illnesses that make urination difficult and elderly or debilitated patients. Do not use Oxecta in patients with intestinal obstruction especially paralytic ileus.

Patients taking Oxecta should use caution when driving a car, operating heavy machinery or doing similar, potentially dangerous tasks as Oxecta may impair abilities needed to drive or perform potentially dangerous activities.

The most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, dizziness, loss of strength/energy, and sleepiness.

Keep Oxecta out of the reach of children. If a child accidently takes Oxecta, seek emergency medical help immediately.

For additional information on the prescribing information for Oxecta, please call 1 (800) 776-3637.

Pfizer Inc.: Working Together for a Healthier World™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

To learn more about our commitments, please visit us at www.pfizer.com.

About Acura Pharmaceuticals

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and commercialization of product candidates intended to potentially deter abuse and misuse utilizing its proprietary AVERSION and IMPEDE® technologies.

Acura will receive a $20 million milestone payment from Pfizer based on the approval of Oxecta.

Acura Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Act”). Acura Pharmaceuticals, Inc. disclaims any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the “Risk Factors” section and other sections of the Companies’ -6-

Annual Reports on Form 10-K for the fiscal year ended December 31, 2010, and their Quarterly Reports on Form 10-Q for the quarter ended March 31, 2011, each of which is on file with the U.S. Securities and Exchange Commission.

Contact: Pfizer Contacts:
MacKay Jimeson, 212-733-2324 (media)
Jennifer Davis, 212-733-0717 (investors)
or
Acura Contact:
Peter A. Clemens, 847-705-7709

Posted: June 2011

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WebMD – FDA Warning – FDA: Repairing Pelvic Organ Prolapse With Mesh Risky

Posted by 4love2love on July 18, 2011

Risks Include Pain, Infection, Need for Additional Surgery
By Denise Mann
WebMD Health News
Reviewed by Laura J. Martin, MD

Surgical clamps in tray

July 13, 2011 — The risks of placing mesh through the vagina to repair pelvic organ prolapse may outweigh its benefits, according to the FDA.

Risks include mesh protruding out of the vaginal tissue (erosion),pain, infection, bleeding, pain during sexual intercourse, organ perforation from tools used in the mesh placement, and urinary problems.  Additional surgeries and/or hospitalization may be needed to treat the complications or remove the mesh.

During pelvic organ prolapse, the internal structures that support the pelvic organs such as the bladder, uterus, and bowel drop from their normal position and “prolapse” into the vagina. Pelvic organ prolapse surgery can also be performed through the abdomen or vagina with stitches or surgical mesh to reinforce the repair and correct the anatomy. Surgical mesh is also widely used in hernia repairs and to treat stress incontinence.

In 2010, there were at least 100,000 pelvic organ prolapse repairs that used surgical mesh, and about 75,000 of these were transvaginal. These are the only procedures that the new FDA mesh warning applies to.

The FDA first issued a safety communication in 2008 after they received reports of adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has increased, although they don’t always differentiate between transvaginal and abdominal procedures. The group also reviewed the literature on the use of mesh for this procedure.

Now, the FDA will convene an outside panel of experts in obstetrics and gynecology to meet in September 2011 and discuss the safety and effectiveness of surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence.

FDA: Risks Outweigh Benefits

“We do not see conclusive evidence that using mesh for the transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh,” says William Maisel, MD, the deputy center director for science at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. “These devices appear to expose patients to greater risks.”

“Mesh is a permanent implant, and complete removal may not be possible and may not result in complete resolution of complications,” he says.

“This is not an indictment of surgical mesh,” he says. “We are talking about a very specific use of surgical mesh.”

There may still be a role for mesh in certain transvaginal pelvic organ prolapse procedures, he says.

“Some clinicians believe that the use of mesh for transvaginal pelvic organ prolapse is appropriate and is the best treatment option for selective patients such as those with severe pelvic organ prolapse,” he says.

Women who have had surgery for pelvic organ prolapse need to understand whether or not their procedure involved mesh. “For someone considering having a procedure for pelvic organ prolapse, speak with a doctor and understand if the surgery is going to use mesh, and ask about the benefits and why the decision was made,” he says.

Many Support FDA Action

Elizabeth A. Poynor, MD, a pelvic surgeon at Lenox Hill Hospital in New York City, has never used mesh for transvaginal pelvic organ prolapse and likely never will.

“I don’t use mesh in my practice because I have seen a significant number of complications from other surgeons, and have seen how mesh erosion can be devastating for patients,” she says.

As to why use of mesh implants for this surgery took off in the first place, she says it may have a lot to do with the complexity of the procedure.

“This is one of the most detailed and complicated surgeries that we do and unless it is done correctly, it can have a significant chance of failing,” she says. Some surgeons believe the mesh boosts the chances of a successful surgery.

“There has been the general feeling that repairs are better and sounder if mesh is used, but mesh may not be better than the proper surgical correction,” she says.

“Women who are considering prolapse surgery should review the risks, benefits, and alternatives with their surgeon to make sure that it is the right choice,” Poynor says.

“This has been a long time coming,” says J. Eric Jelovsek, MD, a staff physician in the Obstetrics, Gynecology, & Women’s Health Institute of the Cleveland Clinic in Ohio.

Mesh placed transvaginally for pelvic organ prolapse does have some anatomical benefit, but that is it, he says. “Quality of life is no different if mesh is placed or not, and women have a higher risk of complications,” he says.

“This doesn’t mean that you should never have mesh placed transvaginally. It means you have to have an in-depth discussion with your surgeon of the options,” he says.

For women who have had the procedure with mesh, “if you are feeling fine and doing well, there is no reason to come in and get this checked out, but if you have question or concerns, then come in,” he says.

Most of the complications will occur in the year or two after the surgery, but others such as vaginal bleeding, pain with sex, and severe pelvic pain may develop later on.

Robert F. Porges, MD, MPH, director of the division of pelvic reconstructive surgery and urogynecology and a professor of obstetrics and gynecology at New York University Langone Medical Center in New York City, seldomly uses mesh during transvaginal pelvic organ prolapse repair.

But, he says, “in some severe cases where the muscles of the pelvic floor have been severely damaged or failed to develop, replacing the muscle with mesh may play a role,” he says. “Most women deserve an attempt to repair the prolapse using their native tissues and unless it is a failure or a repeat failure, using the mesh may not be as valuable as made out to be,” he says.

In a written statement, the American College of Obstetricians and Gynecologists applauded the FDA’s efforts. “The College supports FDA’s upcoming initiative to convene an advisory committee, the Obstetrics Gynecology Devices Panel, to discuss the safety and effectiveness of [mesh] and notes with appreciation FDA’s willingness to reconsider how it clears mesh products for marketing.”

© 2011 WebMD, LLC. All rights reserved.

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WebMD – You Can Start Feeling Better: 8 Important Things to Do About Depression

Posted by 4love2love on July 18, 2011

Fears and Facts About Antidepressants

WebMD Medical Reference

By Mary Anne Dunkin

Reviewed By Brunilda Nazario, MD

Along with counseling, antidepressants are a common part of treatment for depression. And they are usually effective. Six out of 10 people treated with antidepressants feel better with the first one they try. If the first antidepressant medication doesn’t help, the second or third often will. Most people eventually find one that works for them. Yet many people who could benefit from an antidepressant never try one, often because of fears and misconceptions about them, experts say.

Here are eight common fears about antidepressants, as well as facts that can help you decide if an antidepressant might be right for you.

Fear: Antidepressants make you forget your problems rather than deal with them.

Fact: Antidepressants can’t make you forget your problems, but they may make it easier for you to deal with them. Being depressed can distort your perception of your problems and sap you of the energy to address difficult issues. Many therapists report that when their patients take antidepressants, it helps them make more progress in counseling.

Fear: Antidepressants change your personality or turn you into a zombie.

Fact: When administered correctly, antidepressants will not change your personality. They will help you feel like yourself again and return to your previous level of functioning. (If a person who isn’t depressed takes antidepressants, they do not improve that person’s mood or functioning.) Rarely, people experience apathy or loss of emotions while on certain antidepressants. When this happens, switching to a different antidepressant may help.

Fear: Taking an antidepressant will make me gain weight.

Fact: Like all drugs, antidepressants have side effects, and weight gain can be a common one of many of them. Some antidepressants may be more likely than others to cause weight gain; others may actually cause you to lose some weight. If this is a concern, talk with your doctor.

Fear: If I start taking antidepressants, I’ll have to take them for the rest of my life.

Fact: Most people who take antidepressants need to take them continuously for six to nine months – not necessarily a lifetime. Once an antidepressant gets depression under control, you should work with your doctor to decide when to stop your medication and then decrease your dose gradually. Discontinuing them suddenly may cause problems such as headaches, dizziness, and nausea.

Fear: Antidepressants will destroy my sex life.

Fact: Antidepressants can have an effect on sexual functioning. The problem is usually an inability to achieve orgasm rather than a lack of desire. But because depression itself decreases libido, a medication that eases depression may improve your sex life. As with other side effects, certain antidepressants may be more likely than others to cause sexual problems.

Fear: Antidepressants are expensive and aren’t covered by insurance.

Fact: Antidepressants are usually covered by insurance plans with prescription drug coverage. The cost of antidepressant therapy varies widely, depending on the dosage, the drug you are taking, and whether it is available as a generic. Even without insurance coverage, it is possible to purchase a generic antidepressant for as little as $15 per month.

Fear: Taking an antidepressant is a sign of weakness.

Fact: Like medical conditions such as diabetes or high cholesterol, major depression is a condition that often responds to medication.When depression interferes with your ability to function normally, seeking treatment is not a sign of weakness. It’s a sign of good self-care.

Fear: Antidepressants increase the risk of suicide.

Fact: Studies in recent years have raised concerns that antidepressants may raise the risk of suicide among children, adolescents, and young adults. For example, a 2009 review in the British Medical Journal (BMJ) analyzed 372 studies involving nearly 100,000 people who were taking antidepressants. It found that compared to placebo, use of antidepressant drugs was associated with a small increased risk for suicidal thoughts in some children and young adults, have no effect on suicide risk among those 25 to 64, and reduce risk in those 65 and older.

In 2004, the FDA required manufacturers of antidepressants to revise their labels to include a black box warning statement about these risks.

Other studies paint a different picture. A 2006 study published in PLoS Medicine suggests that the use of antidepressants has saved thousands of lives. Data show that the U.S. suicide rate held fairly steady for 15 years prior to the introduction of the widely used antidepressant fluoxetine (Prozac) and then dropped steadily over 14 years while sales of Prozac rose. The research team found the strongest effect among women.

The bottom line: Regardless of your age or sex, it’s important to see a doctor immediately if you have suicidal tendencies or witness them in others.

 

© 2010 WebMD, LLC.

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Reuters – New ban on popular cribs to take effect next week

Posted by 4love2love on June 25, 2011

Reuters10:30 a.m. EDT, June 23, 2011

WASHINGTON (Reuters) – New safety rules take effect in the United States next week that will ban the manufacture and sale of traditional drop-side rail cribs.

The U.S. Consumer Product Safety Commission ordered the ban on the popular cribs late last year amid growing evidence they had played a role in the suffocation or strangulation deaths of dozens of infants over the past decade.

But hotels, motels and day care centers in the country can continue to use drop-side rail cribs for another 18 months. After December 28, 2012, those businesses must switch to cribs that comply with the tougher new federal standards.

The new rules, the first change in U.S. crib standards in 30 years, also require manufacturers to make mattress supports and hardware used in cribs stronger and more durable and to subject their products to more rigorous safety testing.

 

Copyright © 2011, Reuters

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