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Archive for July 24th, 2011

WebMD – You Asked! Expert A’s to Your Beauty Q’s: Pretty Feet

Posted by 4love2love on July 24, 2011

Step into spring with our expert picks for softer, more radiant feet.
By Ayren Jackson-Cannady
WebMD the Magazine – Feature
Reviewed by Karyn Grossman, MD

In each issue of WebMD the Magazine, our experts answer your questions aboutskin care, beauty, makeup, hair care, and more. In our March-April 2011 issue, Daphne LaSalle, 30, who lives on the U.S. Air Force Base in Altus, Okla., asked about beautifying her feet for summer. We ran her question by two doctors: Eric Reynolds, DPM, a podiatrist in Jersey City, N.J., and Elizabeth Tanzi, MD, who is co-director of the Washington Institute of Dermatologic Laser Surgery in Washington, D.C., as well as an assistant professor of dermatology at Johns Hopkins University. Here’s what they had to say:

Q: What can I do now to get my feet soft and ready to show off by sandal season?

Tanzi’s top picks:

A: Thick, dry patches pop up on heels during winter months because feet are often crammed into heavy socks and boots that don’t allow for effective exfoliation of dead skin. To loosen up that scaly epidermis, use a nightly cream likeDr. Scholl’s Ultra Overnight Foot Cream($6.99), containing aloe and palm oil to soothe tough skin.

To buff the dead skin away once it’s been softened, try the PedEgg Pro Pedicure Foot File with Handle ($12.99). It’s better than a pumice stone for gently sanding down thick skin on the heel and ball of the foot because its stainless-steel micro files stay sharp. Once the bottoms of your feet are smooth, keep them hydrated with an emollient-rich lotion likeL’Occitane Shea Butter Foot Cream ($26), which is packed with moisture-locking shea butter.

If you painted your toes in rich, dark hues throughout the winter, you may be noticing some nail yellowing. Take a break from polish for a week or two, and the discoloration will slowly fade. Once you’re back to coating your toenails in polish, be sure to start with a clear base coat without formaldehyde, a chemical that can react with the keratin protein in nails and make them change colors. The formaldehyde-free OPI Start-to-Finish Base & Top Coat ($12.50) is a good one to try.

Reynolds’s top picks:

A: During winter months when humidity is low, skin dries out more rapidly. In some cases, feet get so dry they peel or crack. While there are plenty of prescriptionmedications that work wonders, I like to start with home remedies, which are inexpensive and can be just as effective.

To soften super-dry areas, soak your feet in original Listerine AntisepticMouthwash ($4) (yes, Listerine!) once or twice a week. Mix one part Listerine with two parts warm water in a basin and soak your feet for 15 to 20 minutes, then apply a moisturizer like Eucerin Plus Intensive Repair Foot Creme ($5.59), which contains hydrating urea. In addition to skin-sloughing benzoic acid, Listerine contains ethanol, which kills bacteria, fungi, and germs that can lead to athlete’s foot.

Coating feet in a cream like Burt’s Bees Thoroughly Therapeutic Honey & Bilberry Foot Creme ($10), which is loaded with moisture-replenishing honey and jojoba oil, and wearing socks to bed is an excellent way to lock in moisture for softer feet. If you can’t stand to sleep in socks, place a humidifier at the foot of your bed to keep feet hydrated. Treat thick, dry patches on your feet by massaging them with Vicks VapoRub topical ointment ($3) in the p.m. to battle bacteria while you sleep.

Symptoms of Common Foot Problems

A normal nail bed is pink and smooth. Anything other than that may be a sign of a serious medical condition, Reynolds says. Here’s what to be wary of.

Are your nails brown or black?

See a doctor ASAP. A black or brown spot on your nail could be an indication ofmelanoma, the most dangerous form of skin cancer.

Are they green?

This might be a bacterial or fungal infection caused by trauma to the nail. The tint could be from trapped fluid or pus underneath the nail.

Are there horizontal ridges?

Bumpy lines that run across the nail may be an indication of chronic eczema on the skin under or around the toenail.

Are there vertical ridges?

Some people with rheumatoid arthritis or problems with circulation have lines running along the length of their toenails.

The opinions expressed in this section are of the experts and are not the opinions of WebMD. WebMD does not endorse any specific product, service, or treatment.

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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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Massage Beats Meds for Lower Back Pain, Study Says

Posted by 4love2love on July 24, 2011

TUESDAY, July 5 — Massage therapy may be better than medication or exercise for easing low back pain in the short term, a new government-funded study suggests.

Seattle researchers recruited 401 patients, mostly middle-aged, female and white, all of whom had chronic low back pain.

Those who received a series of either relaxation massage or structural massage were better able to work and be active for up to a year than those getting “usual medical care,” which included painkillers, anti-inflammatory drugs, muscle relaxants or physical therapy, the researchers found.

Structural massage, which focuses on soft-tissue abnormalities, requires more training and may be more likely to be paid for by health insuranceplans, which may equate it with physical therapy, said Cherkin.Lead study author Daniel Cherkin, director of Group Health Research Institute, said he had expected structural massage, which manipulates specific pain-related back muscles and ligaments, would prove superior to relaxation or so-called Swedish massage, which aims to promote a feeling of body-wide relaxation.

“I thought structural massage would have been at least a little better, and that’s not the case,” Cherkin said. “If you’re having continuing problems with back pain even after trying usual medical care, massage may be a good thing to do. I think the results are pretty strong.”

The study, funded by the National Center for Complementary and Alternative Medicine, part of the U.S. National Institutes of Health, is published in the July 5 issue of Annals of Internal Medicine.

Participants were randomly assigned to one of the three groups: structural massage, relaxation massage or usual care. Those in the massage groups were given hour-long massage treatments weekly for 10 weeks.

At 10 weeks, more than one-third of those who received either type of massage said their back pain was much better or gone, compared to only one in 25 patients who received usual care, the study said. Those in the massage groups were also twice as likely in that period to have spent fewer days in bed, used less anti-inflammatory medication and engaged in more activity than the standard care group.

Six months out, both types of massage were still linked to improved function, Cherkin said, but after one year, pain and function was almost equal in all three groups.

Noting that most Americans will experience low back pain during their lifetime, Cherkin said another benefit of massage is its relative safety.

“Maybe one of 10 patients felt pain during or after massage, but most of those thought it was a ‘good pain,'” he said. “A good massage therapist will be in tune with the patient and will ask what hurts.”

One of the study’s weaknesses was that those who were assigned to usual care knew that others were receiving massage therapy and may have been disappointed to be excluded, tainting their reported improvement, said Dr. Robert Duarte, director of the Pain and Headache Treatment Center at North Shore-LIJ Health System in Manhasset, N.Y.

“I think massage therapy can be useful for patients with back pain, but more as a . . . supplemental therapy,” Duarte added.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more on low back pain.

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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

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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: Nature Relief Instant Wart and Mole Remover – Risk of Severe Skin Burns

Posted by 4love2love on July 24, 2011

June 27, 2011

ISSUE
: Nature Relief and FDA notified the public of a recall of Nature ReliefInstant Wart and Mole Remover.  FDA has advised that the active ingredient, calcium oxide, can cause severe burns of the skin, particularly to areas of thin or sensitive skin, such as the face, area around the eyes, and genitalia. FDA has received a report of an injury associated with the use of this product, including burns to the skin that required medical attention.

BACKGROUND: This product is sold as a kit, which contains the following items: two small containers labeled “Repair Cream”, one container of “Antiseptic Wash”, a package of “Triple Antibiotic Ointment”, toothpicks, and a “vanity kit” with cotton balls, swabs, and nail files.

RECOMMENDATION: Consumers who purchased Nature Relief Instant Wart and Mole Remover should immediately discontinue their use and discard the remaining contents. It is recommended that consumers discard the product and contents inside a plastic bag and place it into the garbage for safe disposal, in order to expedite the recall process and avoid further handling. Consumers are advised to have moles reviewed by licensed medical professionals and ensure they are not cancerous.

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 Alert – Recall: Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg) – Bottle Mislabeled

Posted by 4love2love on July 24, 2011

June 27, 2011

ISSUE
: Qualitest and FDA is notifying pharmacists and patients of a recall to the retail level of specific lots of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility that the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone. Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction. Side effects due to caffeine are less likely, due to the small amounts in this formulation, however, those individuals with a sensitivity to caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution.

BACKGROUND: The recall includes the following products:

  • Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B

These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the manufacturer’s bottle. Tablet descriptions and photographs of tablets for these two products are provided in the firm’s press release.

RECOMMENDATION: Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product. All patients who have filled prescriptions of Hydrocodone Bitartrate and Acetaninophen manufactured by Qualitest, are asked to double check the identity of their tablets.

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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