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FDA Warns Against PPA |
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Part 1: Substance May Contribute to Stroke Risk
The U.S. Food and Drug Administration recently released a public health advisory on phenylpropanolamine, also known as PPA. The substance is in over-the-counter weight loss products and cold medications. The advisory reported that taking products containing PPA increases risk of hemorrhagic stroke in women. Men can be at risk as well.
I recently talked to FDA spokesperson Laura Bradbard about PPA. "OTC weight loss products contain PPA and eventually they will be removed from the shelves," she explained. The FDA has already asked manufacturers to remove their products from the market. Unlike a recall, PPA's removal from the market is voluntary on the part of the manufacturers. Bradbard said a recall was not done "because it doesn't pose an eminent hazard."
Manufacturers are complying with the FDA's request. Bradbard said, "They [the manufacturers] of course do not want to be part of an catastrophic event." The manufacturers are looking into alternative substances than can be used in lieu of PPA in their weight loss products. There are many other cold medications available that do not contain PPA. Bradbard explained what will happen next: "The FDA will write a final rule against PPA. It will not be listed on the next monograph of safe substances. Manufacturers will no longer be able to process PPA."
Bradbard said that PPA affects the central nervous system and heart rate. "In weight loss products it is used to control appetite," she continued. "It serves as a decongestant in cold medications." Products containing this substance have been on the market since the 1970s. Dexatrim, for example, is one of the most popular OTC weight control products containing PPA.
According Bradbard, the FDA has been interested in PPA's effects for years, but a study on its risks had not been completed until recently. "Since the FDA does evaluations, not research, we could not do our own study, so we sponsored the Yale Study along with the Consumer Products Association." When presented with the study, the FDA analyzed the results and concluded that PPA should not be considered safe. The FDA says the typical risk of hemorrhagic stroke is very low, but recommends that consumers not use any products that contain PPA.
Next page > What Should Consumers Do?
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