Retailers Voluntarily Pull Cold Medicines Following FDA WarningNov 7, 2000 | WebMD Medical News Retailers nationwide began pulling several brands of over-the-counter cold medications and diet aids after the FDA warned Americans Monday that an ingredient found in those products could cause a stroke, even in healthy individuals ages 18 to 49.
The ingredient, phenylpropanolamine or PPA, is found in nasal decongestants and appetite suppressants. Examples of products that may contain PPA include Contac 12-hour cold capsules, Robitussin CF, Tavist-D, some Alka-Seltzer PLUS cold medicines, and some Triaminic products (check the labels), as well as the diet aids Acutrim and Dexatrim.
Among the retailers that currently are pulling these products as a result of the FDA alert are national pharmacy chains such as Walgreens, CVS, and Rite-Aid. In total, about 100 companies are expected to voluntarily stop marketing products containing that ingredient while the FDA drafts new rules that would, in effect, ban its use.
Besides warning consumers against the use of PPA-containing products, the federal agency also asked companies that make PPA-based products to voluntarily cease making these medications. In response, larger U.S. drug-makers such as SmithKline Beecham and Bristol-Myers Squibb, for whom these products represent a small part of their annual sales, have also agreed to no longer market products containing the chemical.
But not all manufacturers of PPA-based products are expected to comply. The FDA alert was based upon a five-year long Yale University study, which the industry representatives say failed to demonstrate that the chemical represents a true public threat. As a result, some manufacturers are expected to protest both Monday's action and the ensuing rule-making process, during which the FDA will seek to establish an effective ban.
Still, there are steps consumers can take to protect themselves, according to the agency. Among those are to check each product's label for PPA, the FDA says. Consumers can also look for other alternatives such as nasal sprays and products containing psuedoephedrine, a chemically similar but safer alternative to PPA. If unsure about a specific product, consumers can also call the FDA at 1-888-INFO-FDA or (301) 827-4570 to get answers to specific questions.
There are no alternatives to the over-the-counter diet aids. So, consumers seeking a new diet aid should contact their doctor to discuss possible prescription alternatives or other options, the agency advises.
But above all, consumers should remember that there is no reason to panic, the agency says. PPA has been in use for about 50 years, and the risk of suffering a stroke from taking these medications appears to be extremely low, the agency notes. FDA officials add that their reason for issuing the public alert simply was because they no longer believe that the benefits of these products outweigh that risk.
"That's absolutely right," agrees Raymond Woosley, MD, PhD, chair of pharmacology at Georgetown University School of Medicine in Washington. While the incidence might be rare, the consequence is tremendous, he explains. "My concern is that people will now revert to more dangerous products," he tells WebMD, noting that some seemingly safer alternatives such as the dietary supplement ephedra may be equally as dangerous.
Ephedra, also known as ma huang, is a common ingredient in dietary supplements that claim to help people lose weight and increase their energy levels. "But a lot of people don't realize that the body converts ephedra into PPA," Woosley says. "We have a lot of medications still out there that can cause harm," he adds, while observing that the literature regarding the connection between PPA and strokes has been in textbooks for about 40 years.
The Yale study that promoted the FDA alert was published early by The New England Journal of Medicine because of its "potential clinical and public health implications." According to the results of the study, women aged 18 to 49 who had taken PPA as an appetite suppressant were 16 times more likely to suffer a hemorrhagic stroke, a type of stroke characterized by bleeding in the brain. First-time users of PPA products were three times more likely, according to the study.
But in discussing the results at an October FDA public meeting, the researchers did note that although the results suggest that PPA in appetite suppressants, and possibly cold remedies, is an independent risk factor for women, there was no evidence of an increased risk in men. The researchers also noted that their results were somewhat tainted by their inability to account for other risk factors such as smoking and the participants' inability to recall the exact product taken.
Still, "I think the study is valid," says Woosley, who often serves as a consultant to both the FDA and National Institutes of Health. "Even if it causes only one stroke, it's simply not worth it," he tells WebMD.