Acetaminophen for Your Migraines? The FDA May Ban Some Medications
When Migraine abortive medications fail or if we can't take abortive medications, we often turn to rescue medications. Many of these medications contain acetaminophen. Actually, even one of our abortive medications contains acetaminophen -- Midrin.
This makes me wonder how many of you have been following the headlines about acetaminophen and medications made with it...
• FDA Panel Advises Smaller Doses of Painkillers
• FDA panel urges ban on Vicodin, Percocet
• If 2 Painkillers Are Banned, What Next?
What's the reason for all of this? The high incidence of liver damage related to acetaminophen overdose. According to an FDA statement:
"This drug is generally considered safe when used according to the directions on its labeling. But taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver failure, and even death."1
The FDA panel voted on several recommendations:
- In a vote of 21-16, the FDA panel voted to lower the current daily maximum dosage of acetaminophen (now 4,000 mg), but the panel wasn't asked to recommend a new daily maximum dosage.
- In a vote of 24-13, they voted to limit the maximum for a single dose of acetaminophen to 650 mg. To give you a point of reference, today's single two-tablet dose of Extra Strength Tylenol contains 1,000 mg.
- A majority of the panel voted that the 1,000 mg maximum dosage be available by prescription only.
- With the vote at 20-17, the panel voted to ban prescription medications that combine acetaminophen and an opioid -- medications such as Vicodin and Percocet. Their rationale was the number of deaths related to this type of medication as opposed to over-the-counter medications containing acetaminophen
It should be noted that the FDA is not required to accept the panel's recommendations.
During a press conference, Dr. Sandra L. Kweder, deputy director of the FDA's Office of New Drugs at the Center for Drug Evaluation and Research made a statement that may hold a clue as to what the FDA will do with the panel's recommendations:
"I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen, both for over-the-counter products and also prescription combination products... There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminophen combination products. If we don't eliminate these combination products, we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products."2
Summary and comments:
The recommendations from the FDA panel are:
- Lower the recommended daily maximum dosage for acetaminophen.
- Lower the maximum recommended single dose from 1,000 mg to 650 mg.
- Make the current 1,000 mg dosage available by prescription only.
- Ban compounded medications that contain acetaminophen and an opioid. (Vicodin, Percocet, Tylenol #3 and #4, Fioricet with codeine, etc.)
I fail to see the benefit of reducing the maximum dosages since the reported liver damage is OVERdose-related. The FDA report on acetaminophen and liver damage said it's because of a lack of consumer awareness that acetaminophen can cause liver damage. Especially with over-the-counter acetaminophen products, if consumers aren't following label instructions now, will they follow the labeling instructions about lower dosage limits? I doubt it.
It's disturbing to me that the panel recommended only limitations and didn't recommend any consumer education about the risks of acetaminophen. Limiting dosage amounts without educating consumers about the risks is both short-sighted and insulting. And, it won't stop people from simply taking more tablets of over-the-counter acetaminophen. This is not the answer.
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1 NPR. "FDA Panel Advises Smaller Doses of Painkillers." NPR.org. June 30, 2009.
2 Reinberg, Steve. "FDA Panel Urges Ban on Vicodin, Percocet." HealthScout. July 1, 2009.
3 Gardner, Amanda. "If 2 Painkillers Are Banned, What Next?" HealthDay. July 2, 2009.