Panel Wants FDA To Review Painkillers

Armen Hareyan's picture
FDA to review pain medications

An expert medical panel has reported on the toxicity dangers of the most commonly used analgesic drug in the U.S. - acetaminophen. It recommended the Food and Drug Administration to decrease the safety dosing for acetaminophen preparations in over-the-counter drugs. The panel also wants FDA to label clearly the medications that do contain acetaminophen, and remove prescription pain medications that contain acetaminophen such as Vicodin and Percocet from the market.

The FDA doesn’t have to follow the panel’s recommendations and even if it does it will take years to implement the changes.

The FDA is part of the U.S. Department of Health whose mandate includes protecting the public health by supervising the safety of drugs. However, as a practicing physician I have found the FDA to be a source of troublesome and often poor quality information, along with a lot of double-talk.

The acetaminophen problem is not new. Acetaminophen overdoses cause liver failure and death and the use of acetaminophen in over-the-counter pain killers, cough medications and allergy and cold medications is ubiquitous.

As a consequence, the benefits of this drug have been offset by persistent overdosing caused by ignorance and by patients taking too many different preparations with acetaminophen in them.

The drug has been on the market since the 1950s and has been present in more and more medications besides Tylenol and Excedrin. In 2002 an advisory panel recommended the over-the-counter products containing acetaminophen be clearly labeled on the package.

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It took six and a half years and the death of more than 2,800 people from acetaminophen-related liver failure to get the recommendation implemented in April of this year.

However, clearly that is not enough.

While the FDA ponders what to do with the facts that overdosing on acetaminophen causes liver failure and death, facts known for decades, the public and physicians must take the problem into our hands and solve it.

Before writing a prescription for anything, physicians must be informed by the patient of all medications and supplements they are taking. Intake forms in doctors’ offices must include this information on every patient.

Patients have to realize that every medication they take interacts with every other medication. Patients go from doctor to doctor and often do not realize that doctors can’t guess what another doctor has prescribed. T

The doctor-patient relationship is the most important part of the puzzle. If the doctor and the patient work together with the goal of helping the patient feel better, the amount of medication prescribed will diminish and the risk of mixing drugs and possibly get toxic from them will also decrease.

Written by Dr. Erika Schwartz, Chief Medical Officer of Cinergy Health