Ephedra & PPA
Unfortunately, the popularity or prevalence of a drug or pharmaceutical ingredient does not mean it is safe. This is particularly true with Ephedra and PPA, which has been very much on the front lines of pharmaceutical litigation.
Ephedra was banned by the FDA on April 12, 2004.
SimmonsCooper has taken an early and active role in Ephedra litigation, recovering more than $15 million for our clients.*
Ephedra was billed as a “natural” product, and as a nutritional supplement. It was not officially a “drug” and therefore not regulated by the Food and Drug Administration. Millions of people took the thousands of weight loss and performance-enhancing products that contained Ephedra. These products included Metabolife 356, Xenadrine RFA-1, Stacker 2, Hydroxycut, Metaboless, Metabolift, Metabolite, Ripped Fuel and Herbalife.
In the long run, these products turned out to be far from safe.
Thousands of adverse reactions related to Ephedra were reported to the FDA, including stroke, heart attack, hypertension (high blood pressure), tachycardia (irregular heart rhythms) and death.
PPA has been banned by the FDA.
Unfortunately, the prevalence of a pharmaceutical ingredient does not mean it is safe. This is particularly true with pheynlpropanolamine (PPA), which, until recently, was an active ingredient in a wide variety of medicines, including cold remedies and weight-loss aids.
A study by the Yale University School of Medicine, which was later cited by the FDA in a health advisory bulletin, showed that PPA was associated with an unusually high incidence of hemorrhagic and possibly ischemic strokes, particularly in women. As a result, the FDA concluded PPA was not safe for over-the-counter use.
After the FDA’s advisory, most manufacturers reformulated their products to no longer contain PPA. However, e-mails continue to circulate warning consumers to stay away from certain name-brand cold remedies. According to the FDA much of this information is outdated.
If you have cold remedies in your medicine cabinet, we recommend you check the ingredients on those medicines to ensure they do not contain pheynlpropanolamine, or PPA. If you have medicines that still contain these ingredients, you should dispose of them right away.
For more information about how we identify potentially dangerous drugs and to determine a manufacturer’s liability, click here. Or learn more about other areas of pharmaceutical litigation.
* Please note that recovery results vary per client. The recovery amounts in each case reflect the specific facts of that case. Further, recovery amounts in past cases are not a guarantee of future results.