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...Still, if the FDA does decides to follow the committee's advice, it would represent an aggressive attempt to address the growing problem of liver problems associated with the non-prescription painkiller - one that goes beyond simply adding another warning label on a pill...
...despite its widespread use, there have been growing concerns about the non-prescription drug's effects on the liver. The 13-member FDA committee convened specifically to address liver toxicities due to acetaminophen overdose. The group of doctors and patient representatives concluded that the daily maximum dose of acetaminophen should be reduced from the current allowable 4 g and that the maximum single over-the-counter level be set at 650 mg, down from the current...
...label advising users to consult their physician when using the pain reliever in combination with alcohol. In 2002, the medication earned a warning advising users to avoid taking more than two acetaminophen-containing products at the same time. Nevertheless, in a study of adverse event reports submitted to the FDA since the 2002 label change, the number of liver problems has doubled, says Bill Soller, a professor of pharmacy at the University of California, San Francisco, who conducted the survey. "People don't read labels, and physicians aren't doing the communication in the office," Soller says. "At some point...
...There's no guarantee that the FDA will actually follow the advisory committee's advice and reduce the over-the-counter dose of acetaminophen. And even if the agency does, some experts aren't convinced that the move will lead to fewer liver toxicities associated with the medication. "Honestly, I don't think that is going to solve the problem," says Ruha. "Most of the problem is with the prescription pain medications that contain acetaminophen." Many people using drugs such as Vicodin or Percocet still don't feel relief from their pain and either abuse their prescription or supplement with...
...Arizona FDA Crackdown The Food and Drug Administration warned consumers to stop using three Zicam cold and allergy products, after receiving more than 130 complaints that the popular sprays and swabs can permanently damage or destroy users' sense of smell. The announcement highlights the FDA's attempt to regulate drug companies more aggressively and underscores the agency's lack of power--it cannot order product recalls and does not consistently monitor "homeopathic" remedies like Zicam. Matrixx Initiatives, the product's manufacturer, refused to stop selling the medications and called the alert "unwarranted." In 2006 the company, based in Scottsdale, Ariz...