LEGAL HELP CENTER - Daypro

Daypro News:

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Also known as oxaprozin, Daypro is a prescribed drug known as an NSAID (non-steroidal anti-inflammatory) manufactured by G. D. Searle & Company. Daypro is used to treat the pain and inflammation of osteoarthritis and rheumatoid arthritis and approved by the FDA in 1992. The U.S. FDA rejected Daypro on three prior submissions.  The request for approval took nearly 10 years. The cause for the previous rejections was due to lack of substantial evidence that it was any more successful than any existing drug to treat arthritis, and because of certain increased incidence of adverse events.  Upon it's approval, the FDA established Daypro to be comparable to, but no better than, aspirin. However, it did have the advantage of once-daily dosing.

Although, the drug has a very long half-life (the time it takes for the blood plasma strength of the medication to be lessened by one-half). This means that the amount of drug available for therapeutic (and toxic) effect is greater in the blood stream for a longer period of time, which increases it's propensity to cause toxic reactions, particularly in women and persons of low body weight.

During its first year on the market, Daypro had an increased reporting rate of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (SJS & TEN) per one million prescriptions than any other prescribed NSAID in its first promotional year in the U.S.; and by April of 1994, four fatalities have caused serious skin reactions associated with this drug.  Furthermore, Daypro and Feldene (piroxicam), a drug already identified to be connected with SJS/TEN, had the maximum reporting rate of all serious skin reactions during their first marketing years. 

WARNING TO FEMALE PATIENTS:  The figure of post-marketing reports of SJS/TEN individuals prescribed this drug per one million prescriptions was nearly 80% women!  This data is consistent with the clinical trials on the drug. The report shows that women have a higher percentage of adverse skin effects of all types to this drug than men.