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- Federal Register / Vol. 72, No. 156 /
- Analysis and recommendations re: NSAIDs and CV risk
- New Labeling Required for OTC Pain and Fever Medicines
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In 2005, Wyeth Pharmaceuticals, the manufacturer of Orudis KT, an over-the-counter non-steroidal anti-inflammatory drug (NSAID), informed the FDA that it was discontinuing the manufacture of the 12.5mg ketoprofen tablet. Orudis KT was in the same class as other NSAIDs, like prescription-strength Celebrex, Bextra and Vioxx. It was commonly used for muscoskeletal pain, joint problems and soft-tissue injury,
If you are experiencing serious medical symptoms, seek emergency treatment immediately.
In April 2005, the FDA ordered NSAID manufacturers to change their labels and inserts, including adding a boxed warning of increased risk of cardiovascular (CV) events and potentially dangerous gastrointestinal bleeding with NSAIDs. This edict included label changes in nonprescription NSAID's like Orudis KT. The FDA made this order in response to a flurry of studies indicating increased numbers of cardiovascular events (CV's) among patients using Vioxx, Celebrex and Bextra. Vioxx was withdrawn from the market in September 2004 and Bextra in 2005. Pfizer never withdrew Celebrex, but did cease advertising the medication and began settling lawsuits in 2007.
History --Wyeth Pharmaceuticals
In August, 2005, following the FDA's decision to order changes to warnings on NSAID packaging, Wyeth Pharmaceuticals informed the FDA that it would discontinue manufacturing Orudis KT. In 2006, the FDA issued a statement that Orudis KT was “not withdrawn from sale for reasons of safety or effectiveness.” Wyeth has not spoken openly about its decision to withdraw Orudis KT from the market.
Orudis KT had proved effective in treating certain types of headaches, arthritis and muscular pain that had proved resistant to other analgesics in some patients. Since Orudis was taken off the market, many users for whom ketoprofen has proven effective have purchased large quantities of the medication on eBay and from foreign sources.
The over-the-counter analgesics market depends upon volume rather than high prices. For an OTC medication competing with aspirin, ibuprofen and acetaminophen to return adequate profits to the parent pharmaceutical, sales have to be fairly brisk or the risk of litigation must be relatively low. The risk of NSAID litigation was clearly rising in the wake of the Vioxx and Bextra withdrawals and FDA warning requirements on packaging about CV's as a significant side effect of NSAIDs.
Shortly after Bextra and Vioxx were withdrawn in response to the FDA's ongoing investigations of increased CV risk with those drugs, Pfizer pulled its Celebrex TV and print ads. In the midst of these very public troubles with other NSAIDs, Wyeth then withdrew Orudis KT. In 2006, Wyeth got an FDA statement on record that Orudis was not withdrawn because of "safety" or efficacy reasons.