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drug_recall ppaPPA stroke related lawsuits have been filed in the thousands. The PPA strokes lawsuits are just not starting to be decided, four years after the FDA recommended PPA be removed. For decades, PPA was found in hundreds of cough and cold medicines as well as diet pills. While PPA strokes risks were alleged, it was not until a 1999 "Yale Hemorrhagic Stroke Project" was completed that the FDA decided to take it off the market.
Even as far back as 1982 there concerns raised about the PPA strokes that were being reported. Despite any warning signs present, FDA approval to sell prescription PPA products on an over the counter basis was granted. In 1989, an executive at Sandoz Pharmaceuticals, now part of Novartis, wrote an official that PPA produced "dire outcomes in small doses; it isn''t only abuse or overdoses which cause problems."
PPA strokes reports prompted the 1991 Congressional hearings and the FDA proposed additional warnings be placed on all PPA containing products in 1996. The drug agency also mandated that PPA producers conduct an epidemiologic study, so pharmaceutical companies commissioned Yale to take part, paying for the five-year, $5 million study, as well as approving the protocol and handpicking investigators that had previously showed doubt about PPA strokes links. When the studies did result in showing PPA strokes correlations the research was called into question by the drug industry.
Internal documents obtained because of PPA litigation indicated drugmakers intentionally kept the results quiet in order to stall government regulation and alerting the public. The FDA did not issue a PPA withdrawal recommendation until 13 months after the Yale study linking PPA strokes had been completed. By this time, the majority of PPA brand names had been reformulated avoided a major interruption in the estimated $500 million to $1 billion a year industry.
Unfortunately, this 13-month delay resulted in hundreds of more PPA strokes to occur. Eventually, the manufacturers did issue new releases and posted Website notices, in addition to sending doctor, pharmacist, and retailer letters in response to the FDA stepping in, but a survey conducted because of the PPA strokes litigation estimated 3.5 million U.S. homes still had PPA containing products 15 months after the withdrawal requests.
Still, the industry maintains PPA strokes are not a high risk and that its own commissioned study results are in question. There are PPA strokes lawsuits against some of the largest, most powerful drug companies.
In November 2000, the FDA asked companies using PPA (phenlypropanolamine) in their cold products to voluntarily take the products off the market because of possible health risks, including links with hemorrhagic stroke in first time female users. Now,...