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FDA's MedWatch Safety Alerts: November 2011

Posted Dec 27 2011 11:47am

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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.

FDA encourages health care professionals and consumers to report problems with medical products, including

  • unexpected and undesirable side effects
  • quality problems, such as a drug with an unusual odor or color, or a device with defective parts
  • unclear or confusing instructions
  • failure to deliver the expected benefit

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 800-FDA-0178
  • Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.

Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.

Warning: Do Not Use ShoulderFlex Massager

FDA has warned consumers to stop using the ShoulderFlex Massager because it can cause serious injury or death.

This personal massage device was designed for home use to provide deep tissue massage to the neck, shoulders and back while the user is lying down. The device was sold in various stores and through catalogs and online retailers (including Amazon) in the U.S.

On Aug. 31, King International recalled all of its nearly 12,000 ShoulderFlex massagers that it has distributed since Oct. 18, 2003. However, FDA has found that the company went out of business and did not follow through with recall procedures, leaving many companies that sell this device unaware of the recall.

Risk: One death and one near-strangulation were reported when a necklace and clothing became caught in a piece of the device that rotates during use. Two other reports involved clothing and hair that became caught in the device.

Recommendations

  • Do not use the ShoulderFlex massager.
  • Throw away the device components separately so that the massager cannot be reassembled and used. (Remove the massage fingers and dispose of them separately. Dispose of the power supply separately as well.)

For More Information

Photo of ShoulderFlex Massager

FDA Safety Communication: Update on Life-Threatening Injuries Associated With the ShoulderFlex Massager

Cholesterol-Lowering Trilipix May Not Lower Other Risks

A study showed that the medicine Trilipix (fenofibric acid)—while lowering cholesterol—may not lower a person’s risk of having a heart attack or stroke. Data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial show no significant difference in the risk of experiencing a major heart-related event between a group treated with Trilipix plus the statin Zocor (simvastatin) and a group treated with Zocor alone.

Information from the study has been added to the Trilipix physician label and to the patient medication guide (paper handout of safety information that comes with many prescription drugs).

FDA is requiring the manufacturer of Trilipix to conduct a study to evaluate the heart and blood vessel (cardiovascular) effects of Trilipix in people at high risk for cardiovascular disease who are already taking statins.

Recommendations

  • Do not stop taking Trilipix medicine without first talking to your health care professional.
  • Discuss the benefits and risks of taking Trilipix with your health care professional.
  • Read the medication guide that you get along with your Trilipix prescription.

For More Information

FDA Drug Safety Communication: Review Update of Trilipix and the ACCORD Lipid Trial

FDA Consumer Update: Limit Use of 80 mg Simvastatin

No Evidence of Increased Risk of Heart Problems With ADHD Drugs

A large, recently completed study showed no evidence that drugs used to treat attention deficit hyperactivity disorder (ADHD) are associated with an increased risk of cardiovascular events (such as stroke, heart attack, and sudden cardiac death) in children and young adults (age 2–24 years). The medications studied include the following:

Stimulants

  • methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin LA, Ritalin-SR)
  • dexmethylphenidate HCl (Focalin, Focalin XR)
  • dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat)
  • lisdexamfetamine dimesylate (Vyvanse)
  • amphetamine, mixed salts (Adderall, Adderall XR)
  • methamphetamine (Desoxyn)

Non-stimulants

  • pemoline (Cylert—no longer marketed)
  • atomoxetine (Strattera)

The study was sponsored by FDA and the Agency for Healthcare Research and Quality, another agency of the U.S. Department of Health and Human Services.

Stimulant products and Strattera should generally not be used in people with serious heart problems or in those for whom an increase in blood pressure or heart rate would present a health problem.

Recommendations

  • Continue your child’s or your own ADHD treatment as prescribed by a health care professional.
  • Immediately see a health care professional if you or the person you are caring for develops chest pain, shortness of breath or fainting while taking medication to treat ADHD.
  • Talk to your health care professional about any questions you may have about ADHD medications.

For More Information

FDA Drug Safety Communication: Safety Review Update of Medications to Treat ADHD in Children and Young Adults

Consumer Update: How Do You Know If Your Child Has ADHD?

Update: TNF Blockers and Cancer Risk

FDA is continuing its safety review of a type of drug used to treat Crohn’s disease, rheumatoid arthritis, ulcerative colitis and other conditions that has been linked to reports of a rare cancer in children, adolescents and adults age 30 and younger. The agency is requiring manufacturers of these tumor necrosis factor (TNF) blocker drugs to conduct in-depth follow-up of reports of cancer cases and expedite them to FDA. Other data FDA is requiring of manufacturers will allow the agency to more completely analyze all reported cancers.

In April, FDA communicated that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma, or HSTCL), occurring mainly in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with the following medicines:

  • TNF blockers, including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab)
  • Imuran (azathioprine)
  • Purinethol (mercaptopurine)

Risk: HSTCL is a fast-growing cancer that is usually fatal. Most of the cases reported have been in people being treated for Crohn’s disease or ulcerative colitis, but also included a person treated for psoriasis and two people treated for rheumatoid arthritis.

Although most reported cases of HSTCL occurred in people treated with a combination of medicines known to suppress the immune system—including TNF blockers, azathioprine, and mercaptopurine—there have been cases reported in people receiving azathioprine or mercaptopurine alone.

Recommendations

  • Do not stop taking TNF blockers, azathioprine or mercaptopurine without talking to your health care professional.
  • Read the medication guide that comes with your prescription for TNF blockers.
  • If you use a TNF blocker or azathioprine or mercaptopurine and you develop any serious infections or cancer, ask your health care professional if he or she has reported the issue to FDA and, if not, urge him or her to do so. You may also report it to FDA yourself through MedWatch.

For More Information

FDA Drug Safety Communication: Update on TNF Blockers and Risk for Pediatric Malignancy

Recall: Unapproved Drug Sold as ‘Sexual Enhancer’

One lot of Virility Max—a product sold as a dietary supplement—has been recalled because it contains an active drug ingredient that is not listed on the label, making it an unapproved drug.

Virility Max is marketed for sexual enhancement. It is distributed in 10-count, white plastic bottles to retail customers in the South Florida area. Only lot 10090571 is included in this recall.

Risk: The product contains a substance similar to sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction. This substance may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Recommendations

  • Stop using this product immediately and contact your health care professional if you have had any problems that you think may be related to taking this product.
  • Return any unused product to the place of purchase or contact the distributor, Keime Inc., at 561-368-2070 Monday through Friday, 9 a.m. to 5 p.m. EDT.

Drug Safety Labeling Changes

In October, FDA required safety labeling changes to be made to more than 45 drug products, including Premarin, Lithobid, Norvasc, Lotrel, Vytorin and Zocor. Changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.

For More Information

Monthly Safety Labeling Changes

This article appears on FDA's Consumer Updates page , which features the latest on all FDA-regulated products.

Dec. 27, 2011

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