"Finally, the Food and Drug Administration (FDA) is proposing to put labels on over-the-counter pain relievers warning of the potential for stomach bleeding and liver damage," Lurie said in his statement. "Our major question is: What took the agency so long?"
According to Lurie, the FDA's Advisory Review Panel recommended in 1977 that products containing acetaminophen bear warnings such as, "Do not exceed recommended dosage because severe liver damage may occur," but the FDA ignored the panel's advice for nearly three decades.
Lurie's Health Research Group testified to the FDA's Nonprescription Drugs Advisory Committee in 2002 that more than 26,000 hospitalizations and 458 deaths each year are related to overdoses of acetaminophen. While more than half the overdoses were intentional -- suicide attempts -- Lurie says reducing the acetaminophen content of pills and selling a smaller number of pills per package could help curb such overdoses, in addition to properly warning consumers of potential overdose damages.
"In addition to requiring labels, the FDA should require that advertisements for these pain medications include warnings, and the agency should make public service announcements to educate the public," Lurie said. "The FDA needs to make up for lost time."
FDA critic Mike Adams said the FDA was "extremely slow, as usual" in taking action that could harm the profits of pharmaceutical companies.
"Over the last three decades, while the FDA sat on clear evidence that these drugs were killing people, our nation has seen three wars, six presidents and more than 10,000 sunsets, but it still has not seen an honest warning label on over-the-counter painkiller drugs," Adams said. "By taking a generation to require these warning labels, the FDA has once again proven itself an utter failure at protecting public health."
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