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U.S. Department of Health and Human Services

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FDA's MedWatch Safety Alerts: March 2010

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After the Food and Drug Administration (FDA) approves a product and it is on the market, the agency continues to monitor that product for unexpected and undesirable side effects (adverse events).

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products 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: 1-800-FDA-0178
  • Phone: 1-800-332-1088

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

Here are some of the most recent safety alerts prompted by reports FDA has received from health care professionals and patients.

Stalevo: Ongoing Safety Review

FDA is evaluating data from a long-term clinical trial that may suggest that people who take Stalevo, a Parkinson’s disease medication, may be at an increased risk for developing prostate cancer.

Stalevo contains a combination of three active ingredients: entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan.

FDA is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer. This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

Recommendations:

  • Be aware that FDA has not concluded that Stalevo increases the risk of developing prostate cancer. FDA is still reviewing the available information to determine whether there is a safety concern or not.
  • Do not stop your treatment with Stalevo or Comtan unless told to by your health care professional.
  • Talk to your health care professional if you have concerns about Stalevo or Comtan.

For more information, see FDA’s Drug Safety Communication on Stalevo.

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FDA Recommends Temporary Suspension of Use of Rotarix Vaccine

Rotavirus causes severe diarrhea and dehydration in young infants. There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. Each of these vaccines is given by mouth in a series of doses during the first year of life.

FDA has become aware that components of an extraneous virus (PCV1) were found in Rotarix. This virus is not known to cause any disease in humans or other animals. All available evidence supports the safety and effectiveness of Rotarix, which has been extensively studied, both before and after approval.

For the time being, while FDA is gathering additional information, the agency is recommending that clinicians temporarily suspend the use of Rotarix for rotavirus immunization. FDA expects to make updated recommendations in four to six weeks.

Your doctor or nurse should know which vaccine your child received. RotaTeq was licensed in 2006, and Rotarix was licensed in 2008. The majority of children in the United States vaccinated against rotavirus received RotaTeq. RotaTeq is made using different materials from Rotarix. FDA has no evidence that DNA from PCV1 is present in RotaTeq.

For more information, see FDA’s Web page on rotarix vaccine.

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Recall: Cardioverter Defibrillators

Boston Scientific is recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted. These include the following company products:

  • Cognis
  • Confient
  • Livian
  • Prizm
  • Renewal
  • Teligen
  • Vitality

FDA is not aware of new safety concerns and does not recommend that any of the devices already implanted be removed.

Boston Scientific stated it initiated its voluntary recall due to manufacturing changes that were not submitted to FDA for review as required prior to marketing and distribution. The company has informed FDA that it will submit the required information for review.

FDA advises that these devices not be used unless and until the agency reviews and approves manufacturing changes the company has made.

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Zocor: Muscle Injury Risk

There is an increased risk of muscle injury in people who take the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to people taking lower doses of simvastatin and possibly other drugs in the statin class.

This finding is based on FDA’s review of data from a large clinical trial and other sources. The agency is also reviewing data from other clinical trials and sources to better understand the relationship between using simvastatin at high doses and muscle injury.

Simvastatin is sold as a single-ingredient generic medication and as the brand-name Zocor. It is also sold in combination with another drug, ezetimibe, as Vytorin, and in combination with niacin as Simcor.

Recommendations:

  • Don’t stop taking simvastatin unless told to by your health care professional.
  • Call your health care professional if you have muscle pain, tenderness, or weakness; urine that is dark or red-colored; or unexplained tiredness.
  • Talk to your health care professional if you have any questions about the use of simvastatin.

For more information, see FDA’s Drug Safety Communication on Zocor.

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Plavix: Lower Effectiveness in Some People

A boxed warning has been added to the drug label for Plavix (clopidogrel), an anti-blood-clotting medication.

Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and heart-related death in people with disease of the heart or blood vessels (cardiovascular disease).

Some people do not convert Plavix to its active form as well as other people. These “poor metabolizers” may not get the same benefit from Plavix.

The boxed warning will include information to

  • warn about reduced effectiveness in people who are poor metabolizers of Plavix.
  • inform health care professionals that tests are available to identify genetic differences that may identify poor metabolizers of Plavix.
  • advise health care professionals to consider using other anti-platelet medications or different dosing for Plavix in people identified as poor metabolizers.

Recommendations:

  • Do not stop taking Plavix unless told to by your health care professional.
  • Talk to your health care professional if you have any concerns about Plavix or to find out if you should be tested for being a poor metabolizer.

For more information, see FDA’s Drug Safety Communication on Plavix.

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Osteoporosis Drugs: Ongoing Safety Review

Recent news reports have raised the question about whether there is an increased risk of a fracture of the thigh bone (atypical subtrochanteric femur fracture) in people with osteoporosis who use medications known as oral bisphosphonates. These medications are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names include

  • Fosamax
  • Actonel
  • Boniva
  • Reclast

The data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of thigh bone fracture. FDA is working with outside experts to gather more information and evaluate the issue further. The agency will update the public once its evaluation is complete.

For more information, see FDA’s Drug Safety Communication on Oral Bisphosphonates.

Recommendations:

  • Do not stop taking your oral bisphosphonate unless told to by your health care professional.
  • Talk to your health care professional if you develop new hip or thigh pain or have any concerns with your medications. 

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

Date Posted: April 12, 2010

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