Darvocet Recall
Darvocet is a prescription painkiller which has been linked to heart problems and risk of overdose, and is now part of a voluntary Darvocet recall. It is manufactured by Xanodyne Pharmaceuticals, Inc, who is recalling the product after the FDA stepped in with new information on the risks of taking the painkiller. Xanodyne Pharmaceuticals, Inc also makes another version of the painkiller, Darvon. Darvon is also a version of the painkiller propoxyphene. Darvocet has acetaminophen added, which is the main difference between the two products. Both are being recalled voluntarily. The exact names of products recalled and their active ingredients are:
- Darvon (propoxyphene hydrochloride) capsules
- Darvon-N (propoxyphene napsylate) tablets
- Darvocet-N (propoxyphene napsylate and acetaminophen) tablets
The recall comes after new data surfaced, and was reviewed by the FDA. The FDA then recommended in November 2010 that Darvocet and Daravon, the brand names of propoxyphene, be recalled. They also informed the makers of the generic versions of the painkillers of Xanodyne’s cooperation in recalling the drugs. The risks outweighed the benefits, according to new empirical data. Therefore, Xanodyne is voluntarily removing Darvon and Darvocet from the market. Generic makers are expected to follow suit.
The problem with the drugs and the reason for the Darvocet recall is propoxyphene. This opioid has been prescribed for mild to moderate pain for decades. It was first approved by the FDA in 1957. There have been requests over the years to the FDA to remove drugs containing propoxyphene from the market. Starting in 1978, requests were denied because the FDA deemed the benefits of propoxyphene to outweigh the risks. Now, with new data, a Darvocet recall has finally taken place in the market.
Warnings of fatal overdose were placed on boxes starting a couple of years ago, and Xanodyne was required to perform more studies on the drug. The studies were to find out more about the effects that propoxyphene may have on the heart. The studies revealed that the drug caused major changes in electrical activity of the heart, leading FDA officials to advise the Darvocet recall.
I have taken Darvocet since July, 2010 and in the past. The pain killer helped in the past, but the past few months ago it did not relieve the pain. In fact, I expeirenced dizziness from taking the medication and had to lay or sit down because I could not function under the influence of it. However, I stopped taking it, but still have the container with pills in it.