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Posts Tagged ‘MedWatch’

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 – 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 – 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 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 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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New FDA Warnings and Alerts

Posted by 4love2love on June 19, 2011

FDA Medwatch Alert

June 13, 2011
ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.
FDA Medwatch Alert

June 13, 2011
ISSUE: FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.

 

News Alert

Sleeptime Head-Cooling Cap Eases Insomnia, Study Finds

June 14, 2011

TUESDAY, June 14 — Not only do cooler heads prevail, they might also sleep better, according to researchers who say they have developed a cooling cap that, when worn during sleeptime, may help treat insomnia.

Read more…

 

FDA Medwatch Alert

June 15, 2011
[UPDATED 06/15/2011] Use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

 

FDA MedWatch Alert

June 15, 2011
ISSUE: Bedford Laboratories, a division of Ben Venue Laboratories, Inc., initiated a nationwide voluntary recall of Indomethacin for Injection, USP, 1mg Single Dose Vial (NDC #55390-299-01, Lot 1948138, Exp. Date September 2011) as it may contain particulate matter. The particulate matter has been identified as active drug substance and not foreign material or contamination.  Particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening.


FDA MedWatch Alert

June 16, 2011
ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

 

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