FDA Claims Phenylpropanolamine No Longer Safe
According to reports, the U.S Food and Drug Administration has announced this week that drugs with phenylpropanolamine (PPA) are no longer safe, and that they are withdrawing applications for products containing the substance.
FDA Withdrawing News Applications for Drugs Containing PPA
The Federal Register notice was issued on Friday stating that the FDA is withdrawing approval of 13 new drug applications and seven abbreviated new drug applications for products containing PPA.
The decision was made after the FDA reviewed results from a published study conducted by Yale Hemorrhagic Stroke Project. The study revealed that PPA increased the risk of a hemorrhagic stroke. PPA has been used as a nasal decongestant and weight control drug in the past, but according to the FDA, the compound is no longer safe to use.
Tavist-D Extended-Relase Tablet by Novartis, Hycomine Syrup by Endo Pharmaceuticals, Contac Extended-Release Tablet by Novartis Consumer Health, and Brommatap Extended-Release Tablet by Teva Pharmaceuticals, USA were among the product applications listed in the notice.
Pfizer withdrew an NDA application in February 2013 for its product DIMETANE-DC that contained PPA and stated that the production of the drug was discontinued and no longer on the market.
Side Effects of Phenylpropanolamine
The following adverse events have been linked to phylpropanolamine (PPA):
- Psychotic disorder
- Atrioventricular block
- Cardiac disorder
- Cardiac arrest