When the FDA switched the prescription pain reliever Motrin (ibuprofen) to over-the-counter status in 1984, a lot of physicians were unhappy. They feared that this powerful NSAID (non-steroidal anti-inflammatory drug) might cause serious harm without medical supervision.

Many doctors opposed easy access to NSAIDs because of side effects such as fluid retention, elevated blood pressure, rash, stomach irritation and ulcers.

The FDA downplayed such concerns. Officials at the agency seemed to think that OTC NSAIDs offered people another valuable option for pain relief without serious risk.

It wasn’t long before brands like Advil and Motrin IB became big sellers. Eventually Aleve (naproxen) hopped on the bandwagon. It is estimated that over 20 million Americans take the OTC NSAIDs ibuprofen or naproxen each day.

Now the FDA has decided the labels on common pain relievers need to be revised. The new warnings will caution consumers that NSAIDs can cause stomach bleeding in people over 60 or those who have had ulcers or are taking a blood thinner. It will also point out hazards for people who combine these drugs with alcohol or take the medicines for longer than directed.

Despite this increased emphasis on stomach problems (and liver toxicity associated with acetaminophen), there will be no warnings that regular use of NSAID pain relievers may increase the risk of heart attack or stroke. These adverse reactions were discovered relatively recently, in the wake of the Vioxx scandal.

What the FDA doesn’t seem to realize is that whatever they put on the label may be irrelevant. Studies have shown that only about one consumer in five reads the instructions and warnings on the label. A few more–nearly one in three–bother to check the dose.

Perhaps that’s why one person in four takes more than the recommended dose of OTC pain reliever. Most consumers seem to think that any drug available without a prescription is safe enough that they just don’t need to worry about it.

Sadly, that leads to far too many overdoses and hospitalizations. Currently, the FDA estimates that as many as 200,000 Americans are hospitalized each year with serious reactions to NSAID pain relievers, as well as acetaminophen and aspirin.

People in pain are caught in a bind. Many of the drugs they rely on for relief may raise blood pressure, cause bleeding ulcers or even increase the risk for a heart attack or stroke. No wonder people are so anxious to find other alternatives to ease their discomfort.

In our new book, Best Choices From The People’s Pharmacy (Rodale Books) we discuss many other options for pain relief, including home remedies, herbal approaches and topical NSAIDs. Drugs like Pennsaid, Voltaren Emulgel or Feldene Gel can provide relief without typical NSAID side effects. The FDA has never approved such medications for sale in the U.S., but they are available in other countries.
We’re pleased the FDA has finally recognized that warnings for OTC pain relievers need to be improved. We only wish all consumers would read the labels and take these drugs seriously.

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  1. MFS

    If a car came with side effect warnings (mechanical failure leading to death, flammable fuel, carbon monoxide in heavy traffic, random exposure to drunk drivers) would everyone walk?

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