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Tuesday
Jun302009

Acetaminophen panel at FDA in the best interests of the consumer

A US Food and Drug Administration panel with a complicated name [The Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee] is actually doing a good thing by reviewing acetaminophen.

It’s a popular drug popping up in all sorts of medicines—cough syrup, menstrual cramp medicaments and sleep concoctions. It’s also used in heavy-duty prescription painkillers like Vicodin and Percocet. The FDA background statement for the June 29-30 joint meeting in Adelphi (Md.) declared, “Acetaminophen is one of the most commonly used drugs in the United States,1 yet it is also an important cause of serious liver injury.”

A number of issues have been discussed, such as drug interactions between Warfarin and acetaminophen and safe dosages when someone drinks alcohol moderately.  [Continues below photo.]

The FDA has in-depth information about acetaminophen and other drugs.
CNN said, “The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated that acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year…The advisory panel could vote to pull over-the-counter drugs that use acetaminophen in combination with other ingredients that treat flu and cold symptoms, allergies or sleeplessness…These combination drugs include NyQuil, Pamprin and Allerest.”

I edited a pharmaceutical publication for more than a decade, and I came to realize that every drug carries risk, mostly involving dosage and observing the Dos and Do-nots of taking the medication. I came to the conclusion early on that if it is possible to do without medication, do so.

However, despite widespread criticism of the pharmaceutical industry, I must say I respect the medical miracles pharmaceuticals have offered us. Patients with AIDS live longer. Breast cancer patients no longer face a death sentence. Diabetes can even, with proper exercise and diet, be controlled.

Conversely, I believe Americans are over-medicated. Our culture doesn’t tolerate pain well and most of us can’t afford missing more than a day or two of work if we have the flu. People want a quick fix for whatever ails so they reach for the little bottle.

Most people tend to take perhaps unintentionally a cavalier approach to over–the-counter and prescription medicine. If it’s legally in the marketplace, a little won’t hurt and a lot may be better. But noncompliance can cost the patient dearly—I’ve often wondered what it costs in healthcare dollars because people don’t take their medicine properly. We already know medication errors in hospitals are very costly.

It’s important for patients to know the often overlooked member of their healthcare team, the pharmacist. That expert is the very best resource for drug information and you should find a pharmacist you’re comfortable with just as you’d find a doctor you like.

Acetaminophen needed a closer look and the marketplace needed more information for the patient.

Posted by Kay B. Day
June 30, 2009

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