FDA unworried by deaths linked to "super-aspirin"
By Lisa Richwine
WASHINGTON, April 20 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Tuesday there is no need to worry about a new ''super-aspirin'' despite reports of 10 deaths among people who took the drug.
The Wall Street Journal reported that Celebrex has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhage. More than 2.5 million prescriptions have been written for the drug in the three months it has been on the market.
But an FDA adviser said such numbers were meaningless.
''Ten cases is absolutely uninterpretable,'' Dr. Steven Abramson, chairman of rheumatology and medicine at the Hospital for Joint Diseases in New York, who chairs the FDA's arthritis advisory committee, said in an interview.
Celebrex, made by Monsanto subsidiary G.D. Searle & Co. (MTC - news), is one of a new class of painkillers called COX-2 inhibitors. They were designed to battle pain and inflammation without the side-effects of aspirin and related drugs such as ibuprofen, which can cause internal bleeding.
The FDA keeps tabs on as many adverse reactions as it can. Just because a death has been reported in a person taking a drug does not necessarily mean the drug caused that death.
An FDA spokeswoman said she could not confirm the Wall Street Journal's figures, but said she was not worried.
''We don't believe this represents a signal at this point, because you have to take into account the 2 million prescriptions,'' she said. ''We would continue to monitor this and look at the gastrointestinal effects.''
Monsanto spokeswoman Scarlett Foster said the Wall Street Journal story ''erroneously links the data'' that were reported to use of Celebrex. ''It's wrong to make that link,'' she said.
''At this time, there isn't any evidence that points to a causal relationship between a patient's death or hospitalization to the use of Celebrex,'' Foster added. ''You really have to consider other medical conditions as you analyze these cases.''
Abramson agreed, saying more information was needed before any link could be made between Celebrex and the deaths.
''Were they taking an aspirin a day? Low doses of aspirin can cause acute hemorrhaging,'' he said. ''We don't know what over-the-counter medications these people were taking.''
Steve Geis, Searle's vice president for arthritis clinical studies, said that of the 10 deaths reported, eight had prior histories of heart, liver or gastrointestinal problems.
Abramson, whose committee recommended approval of Celebrex, said information from trials showed Celebrex is safe and effective when used as prescribed.
Celebrex, known generically as celecoxib, went through the approval process on a fast-track basis, winning the marketing go-ahead six months after it submitted the application.
The FDA was eager to approve one of the COX-2 inhibitors because side-effects are so serious from aspirin and related drugs, known as non-steroidal anti-inflammatory drugs (NSAIDS). NSAIDS can cause potentially fatal stomach bleeding.
Last year Dr. Gurkirpal Singh of Stanford University in California estimated that 16,500 people died from gastric bleeding every year in the United States.
Several companies are also developing COX-2 inhibitors which have the potential to take a huge chunk out of the $5 billion to $12 billion worldwide analgesic market. Abramson's panel recommended approval of Merck's (MRK - news) COX-2 inhibitor Vioxx on Tuesday.
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