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FDA Restricts Acetaminophen In Popular Pain Medications

This is a guest post from Dr. Mary Lynn McPherson.


FDA Restricts Acetaminophen In Popular Pain Medications

The Food and Drug Administration (FDA) made an announcement yesterday that affects one of the most common pain medications on the market, and as a consequence may affect countless numbers of the 75 million Americans who experience chronic pain (for perspective, that’s more than the number of people suffering from cancer, heart disease and diabetes combined.) The FDA has asked manufacturers of popular prescription pain medications like Vicodin or Percocet to limit the amount of acetaminophen (also known as Tylenol, or APAP) used in these drugs to no more than 325 milligrams per tablet — the equivalent of one regular-strength Tylenol tablet.

The move came because research has shown that acetaminophen can cause liver damage when taken in higher than recommended doses. The problem is that many over-the-counter medications ALSO contain acetaminophen, and patients may take one or more of these common products (like Tylenol) to reduce their fever or get rid of a headache along with their prescription pain relievers.

Before you know it, you could be taking more than the maximum daily dose of acetaminophen which is 4,000 milligrams. I go out of my way to advise people I work with of this warning, but not everyone takes time to talk to the pharmacist and not all pharmacists make themselves readily available. That is why it is critically important that you talk to your pharmacist to make sure that you are not taking more than this amount. The pharmacist is the last stop between you and medication misuse — you could be taking a medication that contains acetaminophen and not even know it. Read more »

Painkiller Safety

Perhaps as many as one in every five American adults will get a prescription for a painkiller this year, and many more will buy over-the-counter medicines without a prescription. These drugs can do wonders — getting rid of pain can seem like a miracle — but sometimes there’s a high price to be paid.

Remember the heavily marketed COX-2 inhibitors? Rofecoxib, sold as Vioxx, and valdecoxib, sold as Bextra, were taken off the market in 2004 and 2005, respectively, after studies linked them to an increased risk of heart attack and stroke.

The nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin, ibuprofen (sold as Advil and Motrin), and naproxen (sold as Aleve) seem like safe bets. But taken over long periods, they have potentially dangerous gastrointestinal side effects, including ulcers and bleeding. Kidney and liver damage are possible, too. More recently, some of the NSAIDs have been linked to an increased risk of cardiovascular disease. Low doses of aspirin (usually defined as 81 mg) is an exception and is often prescribed to lower the risk of heart and stroke.

Even acetaminophen, which is often viewed as the safest pain drug and a low-risk alternative to the NSAIDs because it doesn’t have their gastrointestinal side effects, comes with a caution about high doses possibly causing liver failure. Read more »

*This blog post was originally published at Harvard Health Blog*

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