Meds & Supplements, News & Research, Treatment

Warnings Proposed for OTC Painkillers

A painkiller shouldn’t be considered harmless just because it’s sold over-the-counter. A painkiller shouldn’t be considered harmless just because it’s sold over-the-counter. A painkiller shouldn’t be considered harmless just because it’s sold over-the-counter. Get my drift?

Now the FDA wants to spread the message by adding “prominently highlighted” warning labels to all OTC painkillers. Consumers will be warned that drugs containing acetaminophen can cause liver failure and those with aspirin or nonsteroidal anti-inflammatories (NSAIDs) can cause gastrointestinal bleeding.

The NY Times article points out an issue of particular interest to folks with chronic pain — and one that won’t make it to OTC drug labels:

“A recent study of liver failure in which Dr. Lee participated found that the percentage of cases related to acetaminophen overdoses had grown. Many were caused when patients with chronic pain took prescription narcotics bundled with acetaminophen. The new proposal does not address that combination.”

The brand names of the different types of OTC painkillers are many, but here are some of the most well-known. Other brand names can be found by clicking on the drug type.

For more about the proposed changes, see the FDA’s press release.

You can learn about the risks of OTC meds in the NY Times article, Medline’s pain relief section and in these previous posts:

1 thought on “Warnings Proposed for OTC Painkillers”

  1. This is a really important post–it can’t be overstated.

    In fact, the NYT article, if anything, understates the matter. The truth is that at this time, over 50% of all liver transplants are necessary because of the medical use of acetominophen. It’s such a big problem that even the makers of Tylenol have run a commercial asking people not to exceed the recommended amount.

    Gastritis and ulcers are no fun, and most people have been made aware of the cardiac and blood clot risks of anti-inflammatories like Vioxx and Celebrex, but a lot of people tend to think that ibuprofen and acetominophen are benign.

    They aren’t.

    It’s also important to know that a lot of prescription analgesics, like Vicodin, Percocet, Fioricet, Amidrin, (and all their generic names), also contain acetominophen–so don’t double up.

    If you are an intermittent migraine sufferer, and not a chronic headache sufferer, a double-blind randomized controlled trial has established that acetominophen has no role in the treatment of acute migraine. There are better options available.

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