FDA Excuses OTC Products from Limited Acetaminophen Dosages

Last month, the FDA urged health-care providers not to write prescriptions for acetaminophen in dosages larger than 325 milligrams. As we’ve written, the drug, the active ingredient in Tylenol, is a pain reliever with the potential to cause serious liver damage if taken in excess.

So, as covered by the investigative news site ProPublica.org, it’s good that the dangers of acetaminophen are becoming more widely appreciated; but the bad news is that the lower-dose recommendations pertain only to prescription drugs, not over-the-counter (OTC) meds, which is how most people consume them.

The feds’ announcement was directed toward popular prescription medicines that combine acetaminophen with more powerful opioids, such as hydrocodone. They determined that “there are no available data” showing that the benefits of more than 325 milligrams of acetaminophen in a single pill outweigh the risks of taking too much of the drug.

In 2011, the FDA admonished to drug makers to limit the amount of acetaminophen in individual pills, so the January announcement was the latest move over reducing the harm of acetaminophen.

As documented in a ProPublica series last year, for decades the feds have delayed enacting tougher rules on acetaminophen. It’s generally considered safe when taken as recommended, but even relatively small overdoses can cause liver damage, and even death.

According to ProPublica, the drug accounts for about 150 accidental deaths every year, and half of all cases of acute liver failure cases and tens of thousands of emergency room and hospital visits are attributed to it.

In the late 1970s, a panel of outside experts convened by the FDA recommended setting the standard dose of OTC acetaminophen at 325 milligrams per pill because of the risk of liver damage. But the agency allowed single doses to reach 500 milligrams and even 650 milligrams.

Today, says ProPublica, the most commonly sold form of OTC acetaminophen contains 500 milligrams in a single pill. That’s what “Extra Strength Tylenol” is.

The new recommendation for prescription drugs misses the 80% of the market that OTC use constitutes. So although you can get a 650-milligram pill at 7-Eleven, your pharmacist is discouraged from dispensing more than half that amount.

One reason for this, says ProPublica, is that the FDA has more power to regulate prescription drugs than over-the-counter meds.

In 2009, an FDA advisory panel urged limiting both OTC and prescription drugs, but Big Pharma put its big foot down. McNeil, manufacturer of Tylenol, said that 500-milligram pills accounted for 92% of U.S. acetaminophen sales, and suggested that removing them from the market would “burden” consumers by blocking access to pain relief.

McNeil also said that reducing pill strength would require a “significant amount of time” in the OTC regulatory system. If the feds backed off, the company promised, it would add language to the drug labels recommending a lower total daily limit of 3,000 milligrams – or six extra strength pills.

In 2011, it changed the label on Extra Strength Tylenol to reflect the lower recommended maximum daily dose.

Today, McNeil still opposes any reduction in pill size for Extra Strength Tylenol.

In 2011, the FDA warned manufacturers to stop making prescription pills with more than 325 milligrams by January 2014, but said in the recent announcement, that although more than half of all drug makers had complied, some continued to sell the high-dose compounds.

ProPublica asked the FDA how many companies had failed to comply, or what percentage of the market they represented, and it was unable to answer. The agency did say that it would start cracking down on the remaining combination pills. “If manufacturers have not voluntarily withdrawn these products from the market, the FDA will take the necessary steps to withdraw them.”

When? reporters asked. “In the near future,” the agency said.

No one with liver problems should take acetaminophen, and no one should take it in doses larger than 325 milligrams. If you take any other drugs, examine their ingredients before taking Tylenol or other acetaminophen pain relievers – many drugs are compounded with acetaminophen, and consumers often are unaware.

Also, see our child safety blog, “How Big Pharma Caused Infant Deaths Over Confusing Acetaminophen Dosages.”

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