by Jeff Gerth and T. Christian Miller
ProPublica, Jan. 16, 2014
Earlier this week, the US Food and Drug Administration urged health care providers to stop writing prescriptions for pain relievers containing more than 325 milligrams of acetaminophen, the active ingredient in Tylenol.
The agency’s announcement was aimed primarily at popular prescription medicines that combine acetaminophen with a more powerful opioid such as hydrocodone. Agency officials said they had determined that “there are no available data” to show that the benefits of having more than 325 milligrams of acetaminophen in a single pill outweighed the risks from taking too much of the drug.
The announcement followed up on a similar 2011 FDA admonition to drug makers and was the latest turn in a long-running deliberation over the regulation of acetaminophen.
As documented in a ProPublica series last year, the FDA has delayed for decades enacting tougher rules on acetaminophen. While generally considered safe when taken as recommended, relatively small overdoses have been shown to cause liver damage and even death. Each year, the drug accounts for about 150 accidental deaths, half of all cases of acute liver failure cases and tens of thousands of emergency room and hospital visits, according to federal data and scientific studies.
As far back as 1977, a panel of outside experts convened by the FDA recommended the agency set the standard dose of over-the-counter acetaminophen at 325 milligrams per pill, citing the possibility of liver damage. But the agency allowed 500 milligrams and even 650 milligrams single doses of the drug for sale. Today, the most commonly sold form of over-the-counter acetaminophen contains 500 milligrams in a single pill.
A 2008 FDA review found that the agency’s approval for such a dose was based on “few and limited” studies submitted in the 1970s by McNeil Consumer Healthcare, the Johnson and Johnson unit that makes Tylenol. Two studies showed that two 500-milligram pills were “marginally” more effective than two 325-milligram pills, while two other studies showed no difference.
Ninfa Redmond, a toxicologist who helped carry out the 1977 panel’s exhaustive, three-year study, said she was surprised that such big doses continued to be sold 40 years later.
“It never occurred to any of us that you make a product with that high a dose,” Redmond said. “I use the drug when I travel, but I use 325 milligrams,” she added.
Tuesday’s recommendation only applies to prescription drugs, not the over-the-counter products that make up about 80 percent of the market, according to the FDA. That means that you will still be able to walk into a gas station or grocery store and buy pills with up to 650 milligrams of acetaminophen, while your pharmacist is now discouraged from dispensing any product with more than half that amount.
One reason for this is that the FDA has more power to regulate prescription drugs than over-the-counter medicines. (more…)