Wednesday, July 01, 2009

FDA Advisory Panel Recommends Removing Certain Prescription Painkillers From Market

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An FDA advisory panel issued recommendations yesterday that would change the way products containing the pain reliever acetaminophen are regulated. Research has reinforced existing concerns about liver damage and the potential for overdoses related to use of these medications. But discussions of these concerns do not always tell the whole story.

The expert panel recommended the FDA lower the maximum daily dosage and maximum single dosage of over the counter
acetaminophen products (e.g. Tylenol).

The panel declined to recommend taking combination products containing acetaminophen, such as Nyquil or Theraflu, off the market.

Finally, and probably most noteworthy for my readers, the panel recommended the FDA take prescription combination products containing acetaminophen off the market, such as Percocet, Lortab and Darvocet. The FDA is not required to follow the recommendation, but usually does. This could be a big deal for the thousands of chronic pain patients who, like me, rely on these products to make our daily pain bearable.

As the Consumer Health Care Products Association (a drug industry group) rightly points out, 80% of the deaths associated with these products are suicides, not accidents. Further, these products are safe when taken as recommended (i.e. the proper dose is not exceeded and they are not combined with alcohol). Liver damage is rarely seen when patients follow these guidelines. I can certainly see the need for increased education efforts to make people aware of these issues, but to take these prescription pain medications off the market is a mistake. Far more people will suffer when these products are unavailable than currently suffer as a result of using them.

FDA Panel Advises Smaller Doses of Painkillers
FDA Panel Urges Cuts in Acetaminophen Dosage

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DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.