FDA's MedWatch Safety Alerts: March 2010

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On This Page:

• Stalevo:
  Ongoing Safety Review


• FDA
  Recommends Temporary Suspension of Use of Rotarix Vaccine


• Recall:
  Cardioverter Defibrillators


• Zocor:
  Muscle Injury Risk


• Plavix:
  Lower Effectiveness in Some People


• Osteoporosis
  Drugs: Ongoing Safety Review

 
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.

• Online³


• Regular Mail: Use postage-paid, pre-addressed FDA form 3500⁴


• 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 Stalevo⁵.
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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 vaccine⁶.
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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.
For more information, see FDA’s
statement⁷ on this
recall.

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.