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FDA fails to reduce accessibility of paracetamol despite 450 deaths a year

BMJ 2002; 325 doi: (Published 28 September 2002) Cite this as: BMJ 2002;325:678

Confidential documents from the US Food and Drug Administration suggest that the agency has avoided a debate on tough new measures to reduce overdoses from painkillers—to avoid offending the pharmaceutical industry. Ray Moynihan reports from Washington, DC

Staff at the Food and Drug Administration's Office of Drug Safety wanted the United States to consider following the United Kingdom's policy of reducing the public's ease of access to paracetamol to try to reduce the number of deaths from overdose, a concern in both these countries.

But the office's views never reached the FDA's non-prescription drugs advisory committee, which met last week to consider the drug's safety. The result was that the advisory committee recommended only that the drug, known as acetaminophen in the United States, carry expanded safety warnings. No change was recommended in how it is sold.

Drug company executives were delighted with the committee's decision. “I felt really very good,” said Dr Anthony Temple, a vice president of the Johnson & Johnson company McNeil, which dominates the market in paracetamol products, taken by almost 50 million Americans a week. “I'm pleased the panel came up with the same concepts we've come up with already.”

The advisory committee was …

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