FDA Says Darvocet Must Include Stronger Warnings


Darvocet, Darvon and generics for these have not been banned by the FDA but the prescriptions must include stronger warnings about the potential for overdose and death.   The advisory panel was recommending that Darvocet and Darvon be banned but the FDA says that the drug can stay on the market with a warning label on the prescription bottle.  Also included with the prescription will be a special pamphlet that explains the risks of taking too much.

The FDA has also ordered drug manufacturer Xanodyne Pharmaceuticals Inc. to do a study on how taking more Darvocet than recommended can affect the heart.  A study is also to be conducted on how the medication affects elderly people.

According to the MSNBC.com article, the consumer watchdog group, Public Citizen, are not happy with FDA’s decision.

“This is a reckless decision on the part of the FDA unless they believe Americans are resistant to the death-causing properties of this drug in a way that Europeans and people in the U.K. aren’t.  You’ve got a drug which has a barely perceptible benefit and a very clear risk.”

The generic of Darvocet includes both the narcotic propoxyphene and acetaminophen. Acetaminophen has been recently in the news because the advisory panel wants to see over-the-counter dosages of the medication reduced and prescription pain medications with the ingredient banned. If Darvocet has not been banned, what is the likelihood of Vicodin and others like it being banned? What are your thoughts?

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  1. I would not like to see darvocet, vicodin, and the like banned. These are good meds for those of us with chronic pain. Certainly people taking these need to be responsible and have the approval and monitoring/supervision of their medical team. I’ve used vicodin for about four years now, on a strictly as needed basis. Sometimes I go weeks without taking even one. Some weeks I take 1-3 a day, depending on the level and duration of pain. My endo checks liver function regularly as I’ve had liver enzyme problems from tylenol in the past. So far, no problems. I’d just as soon be able to keep on going as I’ve been doing with the vicodin.

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