The New York Times recently reported that the F.D.A. is restricting prescription painkillers in the hope that people will stop getting overdoses of acetaminophen. The problem arises when people take prescription drugs containing acetaminophen together with over-the-counter pills like Extra Strength Tylenol (which also contain the medication).
In 2005 an F.D.A advisory panel wanted to see a ban on Percocet and Vicodin, but the F.D.A didn’t support that advice then or now. Instead, the organization has ruled that manufacturers have three years to take these prescription drugs off the market or reformulate them. Under the new restrictions, the pills can contain 325 mgs. of acetaminophen and that’s it. This means that the pills will have less than half the potency they now have.
Extra Strength Tylenol has more than 325 mg. of acetaminophen and the same advisory panel actually wanted to ban this medication, too. The F.D.A. declined but left the door open for future action.
We’ll be seeing more definitive warning labels on Percocet and Vicodin about the possible overdoses.
These steps will make medication safer. People have to be careful even with products like Tylenol (also known as paracetamol and APAP), since the article warns that even recommended doses of acetaminophen can cause liver damage in some people.
From the article: “More than 400 people die and 42,000 are hospitalized every year in the U.S. from overdoses.” It can happen when you take one medication containing acetaminophen for one type of pain, and another for pain elsewhere or maybe for cold symptoms.
It’s interesting to read the different opinions. A director of the Neuromedicine Pain Management Center at the University of Rochester said that if the FDA had banned Vicodin and Percocet, patients seeking pain relief would have just gone to other “equally risky” pain relief. The current actions give the F.D.A. more time to study the problem. A professor of internal medicine at Southwestern Medical School in Dallas wants to see the two prescription drugs banned because people take greater amounts as they become more tolerant. A Johnson & Johnson spokesperson stood up for Extra-Strength Tylenol, while drug company Abbott said it is determining how to comply.
The F.D.A. has a tough job. Prescription medications help countless numbers of people, but they also have risks and side effects. You constantly have to educate yourself on the benefit-risk ratio.