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.
Dianne Murphy, M.D., is director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy graduated from the Medical College of Virginia and completed her residency in pediatrics at the University of Virginia in Charlottesville. She has been with FDA since 1998.
Q: How does FDA define “children”?
A: For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit.
Q: Are medications that are intended for children clinically tested on children?
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.
Beware of Counterfeit Weight-Loss Drug, Alli
Counterfeit Alli 60 mg capsules (120-count refill kit) are being sold over the Internet. FDA laboratory tests showed that the counterfeit Alli has a different active ingredient, a stimulant found in a prescription weight-loss drug. People using the counterfeit Alli may be taking threetimes the usual daily dose of the stimulant if they are following the dosing directions for Alli, and may be at risk for a stroke or heart attack. The counterfeit Alli looks similar to the authentic product, with a few notable differences (see photos3).
Some previously recalled products were reported to have an unusual moldy, musty, or mildew-like odor that was related to nausea, stomach pain, vomiting, and diarrhea. The odor is caused by a compound believed to result from the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.
McNeil has now applied broader criteria to identify and remove all product lots that it believes may be potentially affected, even if there are no consumer complaints about them.
The risk: The health effects of the compound believed to cause the symptoms have not been well studied. To date, all of the observed events reported were temporary and not serious.
If you purchased a recalled product, stop using it.
Contact McNeil Consumer Healthcare at 888-222-6036 or at www.mcneilproductrecall.com6 for instructions on how to get a refund or replacement, and how to return or dispose of the product.
Contact your health care professional if you have medical concerns or questions.