FDA is ordering manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage.
Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAID). These include aspirin, ibuprofen, naproxen, and ketoprofen.
Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.
People sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.
The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids.
I don’t know if anyone was ever under any doubt that Vioxx was not just a painkiller but a killer, but if it makes you feel any better, yet another study by Dr. Robert Bresalier, a professor of medicine at the M.D. Anderson Cancer Center in Houston, has found that arthritis patients who took the drug, their risk of heart attacks and strokes increase close to twofold and the risk lasted for about a year.
“The good news is that, after a year, the risk seemed to go back down toward normal,” Dr. Bresalier said.
What is even more important to know that the whole class of NSAID is equally dangerous and that includes banned drug Bextra and still available Celebrex. Then your typical over-the-counter painkillers like ibuprofen (Advil, Motrin) and naproxen (Aleve) are quite dangerous as well.