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    Saturday, September 21, 2002

    Tylenol Tumult: The FDA is considering requiring stronger warnings about side effects on over-the-counter acetaminophen bottles. Acetaminophen is the active ingredient in Tylenol and most other non-aspirin pain relievers found over the counter. Taken in the correct dosage they’re the safest of the analgesics, but if you overdose on them, like anything else, they can kill you. The Naderite group Public Citizen is pushing to restrict access to the drug. They’ve managed to find a relative of one of the 100 people a year who recklessly and fatally disregard the instructions for use on the bottle to serve as their tragic spokesperson:

    "You cannot allow more innocent men, women and children to suffer," Kate Trunk, whose 23-year-old son Marcus died of an unintentional overdose, told a panel of Food and Drug Administration advisers. "Death is not an acceptable side effect." About 100 people a year are believed to die from unintentional overdoses.

    Willfully ignoring the instructions on the bottle hardly classifies one as an “innocent victim,” nor does it constitute an “unintentional overdose.” It might not be a suicide attempt, but the overdose is very definitely intentional. The real problem is when people take Tylenol in combination with other products that also contain acetaminophen, such as prescription pain relievers and over the counter cold remedies. (As my public service for the month, here’s a list of products that contain acetaminophen. [warning: pdf file].)

    In view of this, the call for better labeling of content and warnings about the danger of overdosing on over the counter acetaminophen products is justified, but Public Citizen wants to go even further and restrict the use of Tylenol. They want warnings not to take it for more than ten days, which would deprive many arthritis sufferers of a safe and effective means of treating their arthritis pain, and they want it sold only in very small quantities, like antihistamines are. They also want a doctor’s order to dispense more than 100 tablets. That’s going too far. The publicity over this, regrettably, is already making patients shy about using the drug. I had a couple of people tell me yesterday that they would rather use other over the counter analgesics for their minor arthritis pain, like Aleve and Motrin, because of the news reports about Tylenol’s dangers. Those drugs, unlike Tylenol, can cause bleeding ulcers and kidney damage, even when taken in the correct dose, making them riskier than Tylenol. If Public Citizen is truly concerned about public safety, they should consider the full consequences of their political action.
     

    posted by Sydney on 9/21/2002 08:10:00 AM 0 comments

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