FDA Says Products Containing PPA Not Safe
February 4, 2001
On October 19, 2000 an FDA advisory committee issued a warning about an ingredient contained in many popular over-the-counter and prescription cold and weight loss medicines. The committee said that phenylpropanolamine, also known as PPA, may be responsible for hundreds of strokes in otherwise healthy people under the age of 50. The committee said there is evidence that PPA causes hemorrhagic strokes, especially in young women. Uncontrolled bleeding in the brain causes hemorrhagic strokes.
The FDA advisory committee investigating PPA decided that PPA and products containing the substance cannot be considered safe, even though these same PPA containing products have been on the market for years. The advisory committee's unanimous vote is not a recall of PPA but simply a recommendation that the governing body of the FDA consider a ban of the substance.
Researchers who studied PPA found that while the odds of suffering a hemorrhagic stroke after taking a product containing PPA is small, the incidence of stroke was great enough to raise serious questions about the substances' safety. Records show that over 6 billion doses of PPA are taken each year, yet the FDA advisory committee suspects only 500 strokes occur because of PPA annually. Regardless, one preventable stroke is one stroke too many. "The message for women should be, PPA does appear associated with an increased risk of hemorrhagic stroke, but it is not a huge risk," Yale medical professor Walter Kernan said. Professor Kernan pointed out that there are many over-the-counter cold medications and diet drugs that do not contain PPA.
The Consumer Healthcare Products Association, a trade group that lobbies on behalf of over-the-counter drug makers, paid for the Yale study. However, now the Association claims that the researchers' methods were flawed and that the results from the Yale study are not credible. Yale researchers categorically deny the charge, standing by their research as scientifically sound.
Scientists first became concerned with PPA's stroke causing propensities in the early 1980s. Doctors reported several troubling cases of young women suffering hemorrhagic strokes after taking diet drugs and newly available appetite suppressants. Most of these strokes tended to occur within a 3 days of taking medications containing PPA.
Before the Yale study the FDA's official records showed that only 44 people experienced hemorrhagic strokes after taking PPA. However, according to the FDA's Lois La Grenade, those 44 strokes were "literally the very tip of the iceberg," as the FDA only learns of approximately 10% of all adverse drug reactions annually. Apparently, a vast number, around 90%, of PPA caused strokes go unreported.
-- Article Courtesy of InjuryBoard.com
More ...
- PPA Causes Hundreds of Strokes
- Phenylpropanolamine / PPA: Frequently Asked Questions
- FDA Declares PPA 'Unreasonably Dangerous'
.