Prescription Painkillers Affected by New FDA Regulations

The US Food and Drug Administration is making a move that may change how effective your painkillers are.

According to the Independent, the FDA is now mandating that prescription drugs containing acetaminophen, Tylenol's active ingredient, must carry updated labels that warn of possible liver damage. Also, drug-makers have to limit their use of acetaminophen to 325 milligrams to help prevent liver damage.

The new warning will affect some of the drugs typically used in helping fibromyalgia sufferers cope with pain, specifically Vicodin, Percocet, and Tylenol with codeine. Over the counter medications are not subject to the new regulations.

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Sandra Kweder, deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research in a statement.

The FDA says liver damage from painkillers occurred in specific circumstances:

Most of the cases of severe liver injury occurred in patients who took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period, took more than one acetaminophen-containing product at the same time, or drank alcohol while taking acetaminophen products.

Adrienne Dellwo, a fibromyalgia sufferer and writer for the About.com fibromyalgia blog, worries that the new regulations will make drugs weaker and actually encourage patients to take more pills. Dellwo writes: The FDA says it believes these medications will be safer and will still be effective for pain. My concern is that if they're less effective, people may take additional Tylenol and wind up getting more than what used to be in their meds. Either way, the best thing to do if you suffer from fibromyalgia is to talk to your doctor about any concerns you have about your prescription dosage.
1 2 Next
Print Article