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Report: McNeil Lobbied FDA Not to Address Tylenol Risks

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October 15, 2015 — New court documents describe a previously-unreported lobbying campaign launched by McNeil Consumer Healthcare to prevent the FDA from restricting over-the-counter Tylenol.

The evidence was presented at trial by lawyers for Regina Jackson, a woman who was hospitalized with liver damage after taking Extra Strength Tylenol for a few days.

ProPublica reports that McNeil president Peter Luther became concerned about recommendations from an advisory panel to the FDA. In an email to executives in August 2009, Luther wrote:

“It may be time to get members of Congress to put some pressure on FDA. … We’re going to involve key opinion leaders, and we’re going to get them to help us influence the FDA to disregard what the advisors said.”

Six years later and the FDA has only limited the amount of acetaminophen in prescription painkillers (Vicodin, Percocet, etc.) to 325-mg per tablet. McNeil has voluntarily limited the maximum recommended dose to 3,000-mg of acetaminophen per day.

Even so, overdoses of acetaminophen remain the leading cause of acute liver damage in the United States. About 150 accidental deaths are blamed on acetaminophen every year.

McNeil is currently facing over 200 lawsuits in a centralized federal litigation (MDL No. 2436). Plaintiffs accuse the drug-maker of aggressively promoting Tylenol while downplaying its narrow margin of safety.

 

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