From Our 2010 Archives

Health Highlights: April 19, 2010

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

FDA Reconsiders Fate of Diabetes Drug Avandia: Report

GlaxoSmithKline's diabetes drug Avandia could be removed from the U.S. market if the U.S. Food and Drug Administration decides to halt a safety study involving thousands of patients.

In recent years, a number of studies have linked Avandia to an increased risk of heart attacks. The safety study, approved by the FDA in 2007, is comparing Avandia with a Takeda Pharmaceutical diabetes drug called Actos, the Wall Street Journal reported.

A number of experts have said it's unethical to compare a drug with known heart risks to an apparently safer drug and have also called for Avandia to be taken off the market. But the FDA has ignored those concerns until now, the newspaper said.

The agency has asked the Institute of Medicine, a U.S. government scientific panel, to review the ethics of the safety study. One FDA official said that if the study is stopped, the agency would also consider halting sales of Avandia in the United States, the Journal reported.

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FDA Warns Generic Drug Maker Apotex

A warning letter about manufacturing violations has been sent to Canadian generic drug maker Apotex, says the U.S. Food and Drug Administration.

The violations include charred particles in a diabetes drug, contamination of an antihistamine, and drug cross-contamination due to inadequate cleaning of manufacturing equipment, The New York Times reported.

In addition, Toronto-based Apotex failed to notify the FDA in a timely manner about such problems, according to the agency.

Apotex did not respond to requests from the Times for comment about the FDA warning letter. The company is Canada's largest drug maker and the eighth-largest provider of generic drugs in the United States. Apotex drugs were used to fill 94 million prescriptions in the United States in 2009, according to drug industry research firm IMS Health.

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No Evidence of Autism-Related Bowel Disease: Paper

A bowel disease supposedly linked with autism may not actually exist, says a new study.

The disease, autistic enterocolitis, was noted in a discredited paper published about a dozen years ago. The paper, which suggested a link between the measles vaccine and autism, has since been retracted by The Lancet medical journal.

In this new article, reporter Brian Deer asked independent experts to take a closer look at autistic enterocolitis. They failed to find any evidence that it's a real disease, the Associated Press reported. Deer's article appears in the British Medical Journal.

Several studies have found an association between inflamed bowels and autism, but "any firm conclusion would be inadvisable," Sir Nicholas Wright, from the Barts and the London School of Medicine and Dentistry, wrote in an accompanying editorial in the journal, the AP reported.

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