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FDA warns about Acetaminophen Risk

New Risks associated with Acetaminophen

In August 2013 the FDA came out with warnings relating to new risks associated with acetaminophen. Acetaminophen is one of the the most widely used drugs for fever and pain relief in the United States and around the world and is marketed under better known brand names such as Tylenol.FDA warns Acetaminophen risks

The new warnings are linked to three serious skin diseases. Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most serious skin reactions the FDA links, in rare cases, to acetaminophen. Due to these findings the FDA is now requiring that warnings about the possible skin reactions are included on the labels of all prescription medications that contain acetaminophen.

“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” stated Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”

This is not the first announcement for acetaminophen by the FDA in recent years. In January of 2011 the FDA demanded that the amount of acetaminophen in prescription combination medications be limited to no more than 325 milligrams (mg) in each tablet or capsule and required changes to labeling of combination prescription products. The reason behind this change was due to findings that associated acetaminophen with” potential risk for severe liver injury”.

This milligram limit resulted in changes of dosage and strengths of prescriptions affecting  many patients currently using combination medications to manage chronic pain. Combination medications may include opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). Over the Counter medications were not affected by this action.

The FDA has also released a public awareness campaign on Acetaminophen

Newbridge Spine & Pain Center  performs pain management procedures and treatments under a strictly conservative philosophy. Please feel free to contact your Newbridge Pain Management specialist with any questions.

Visit out patient education pages for more information on opioids and to understand the difference between opioid addiction and dependence .

[Source: FDA Consumer Updates]