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Article Summary: Aleve Was Found To Raise The Risk Of Heart Attack Or Stroke 50% Over That Seen With A Placebo
Aleve Was Found To Raise The Risk Of Heart Attack Or Stroke 50% Over That Seen With A Placebo
FDA scientist David Graham testified that he had concerns about five other drugs as well: Accutane for acne; Bextra, a COX-2 inhibitor; Crestor, a cholesterol-lowering statin; Meridia for weight loss; and Serevent for asthma. Their makers defended the drugs' safety.On Dec. 9, the FDA made Pfizer add a warning on Bextra's label. Two studies had shown that short-term use by patients who already had heart disease might trigger heart attacks or strokes. On Dec. 17, the National Institutes of Health announced it was stopping a colon cancer prevention trial because participants receiving Celebrex were at least 2½ times more likely to have a heart attack or stroke than those receiving a placebo.
And if arthritis patients weren't confused enough, NIH announced Dec. 20 that it had halted an Alzheimer's prevention study involving Celebrex and naproxen, sold over-the-counter as Aleve. This time, Aleve was found to raise the risk of heart attack or stroke 50% over that seen with a placebo. Celebrex, Bextra and Aleve remain on the market, although at the FDA's request, Pfizer has pulled Celebrex advertisements. In February, an FDA advisory committee will discuss the safety of COX-2 inhibitors, and Congress is expected to continue the debate about whether the FDA is capable of protecting Americans from potentially risky medicine.
Flu vaccine comes up short - the sudden shortage of flu vaccine, occurring as it did on the eve of the 2004-05 flu season, sent health officials and consumers into a tailspin. Federal health officials quickly instituted a priority list that recommended restricting vaccine to people at high risk for serious illness from flu, such as babies, pregnant women, the elderly and anyone with chronic health problems. Doctors, hospitals and health departments that ordered their vaccine from Chiron were out of luck after the vaccine maker's license was suspended Oct. 5 because of contaminated vaccine, cutting the USA's flu shot supply nearly in half. Customers of Aventis Pasteur, the only other maker of flu shots, shared their bounty in many cases, but that didn't prevent long lines at flu clinics and a lot of scrambling by local and state health officials.
The shortage also brought to light the weaknesses in the vaccine supply system, generating calls for better federal oversight of vaccine manufacturers, efforts to encourage more vaccine makers to enter the U.S. market and more research into new technologies for making flu vaccine. Vaccine makers say they make only as much as they can sell. The challenge, public health experts say, is to persuade more Americans to get a flu shot every year.
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