FDA's MedWatch Safety Alerts: November 2009

FDA's MedWatch Safety Alerts: November 2009

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Early Communication: Safety of Meridia
Recall: Pai You Guo, Marketed as a Dietary Supplement
Recall: Vicks Sinex Nasal Spray
Unapproved Drugs: RockHard Weekend and Stiff Nights
Recall: Dietary Supplements sold by IDS Sports and Bodybuilding.com
Early Communication: Safety of Negative Pressure Wound Therapy Systems
Potential Failure of Powerheart and CardioVive Automated External Defibrillators
Plavix and Prilosec Drug Interaction
After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.

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 a few of the most recent safety alerts prompted by reports received by FDA from health care professionals and their patients.

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FDA's MedWatch Safety Alerts: November 2009