Darvocet Recall: WHY WAS DARVOCET RECALLED?
Darvocet, Darvon & Propoxyphene Recall
Darvocet, Darvon and all propoxyphene containing prescription medications (i.e. the generic equivalents of these brands) have been removed from the U.S. prescription market. The voluntary withdrawal was announced by the FDA on November 19, 2010 according to an FDA Drug Safety communication. The immediate reasons for this removal are:
- Lack of significant benefit from these products over the alternatives
- The risks and dangers of overdose (including accidental overdoses, particularly amongst the elderly - see link below)
- Data that suggests a rare, but potentially serious, heart rhythm abnormality could be caused by propoxyphene usage
As a result of these things, the manufacturer of the brand name products Darvocet and Darvon, Xanodyne Pharmaceuticals, decided to voluntarily withdraw these products from the market, at the request of the FDA. Other manufacturers were notified and requested to do the same.
For an extensive report on the many documented cases of propoxyphene overdose: CLICK HERE.
A BRIEF HISTORY OF THIS DECISION
THE HISTORY OF PROPOXYPHENE WITHDRAWAL FROM THE MARKET:
11/2006: Public Citizen petitions the FDA to begin immediately phasing out the drug due to dangers associated with its use.
1/2009: On January 30, 2009 a joint meeting of two FDA advisory committees was convened for the purpose of discussing the use of propoxyphene-containing pain relievers in the U.S. After reviewing the data, the individuals from this committee voted 14-12 against the "continued marketing" of propoxyphene-containing substances.
The actual minutes of this meeting can be found by CLICKING HERE.
Note: The FDA is not bound to adopt the recommendations of their advisory committees. In they case, they did not decide to request a product withdrawal.
7/2009: Then, in July 2009, the FDA decided to require stronger labeling [see image below] which would warn prescribers about the dangers of propoxyphene overdose. Additionally they asked Xanodyne for studies to help assess the potential for heart rhythm abnormalities.
11/2010: After reviewing the data concerning heart rhythm changes, the FDA decided to request that the drug be removed from the market. The result of this decision is as follows:
- Xanodyne will withdraw Darvon and Darvocet products
- Cornerstone Therapeutics will withdraw Balacet
- Generic propoxyphene containing prescription products will all be withdrawn (this includes products manufactured by Zenith, Mylan, Pliva and others).
Note: Darvon Compound (a combination of propoxyphene, aspirin and caffeine), formerly marketed by Eli Lilly, has not been on the market since March of 2007. This product was available generically.
Black Box Warning Added To Propoxyphene Products in July 2009
A LITTLE INFORMATION ABOUT PROPOXYPHENE
If you have heard about the Darvocet recall, Darvon recall, or propoxyphene recall you may want to know a little more about the drug itself. Here is a very brief overview of propoxyphene:
Propoxyphene is a weak, opioid analgesic (aka a painkiller) which began to be marketed in the U.S. in 1957. It was used for mild to moderate pain. Propoxyphene was available in a variety of strengths and forms (alone or in combination with other drugs), all of which were available generically. Some of these included:
- Darvon (propoxyphene hydrochloride) 65mg capsules
- Darvocet N-100 (propoxyphene napsylate 100mg AND acetaminophen 650mg) tablets
- Darvocet N-50 (propoxyphene napsylate 50mg AND acetaminophen 325mg) tablets
- Darvocet A500 (propoxyphene napsylate 100mg AND acetaminophen 500mg) tablets
- Darvon Compound (propoxyphene hydrochloride 32mg AND aspirin 389mg AND caffeine 32.4mg) capsules
- Balacet 325 (propoxyphene napsylate 100mg AND acetaminophen 325mg) tablets
If you are curious about the "napsylate" name after the word "propoxyphene" it has to do with a little clever pharmacology. Propoxyphene hydrochloride could be dissolved in water and injected by patients seeking to abuse the drug. So....the manufacturers created a new form of propoxyphene (i.e. propoxyphene napsylate) which could NOT be dissolved in water and thus could not be given by injection. Pretty sneaky huh?
COMMENTS AND OPINIONS
What I have said so far are just the facts, as far as I know them, about the propoxyphene withdrawal from the market in November 2010. However, being in this profession, I am expected from time to time to give my opinion and perspective on decisions like this.
What follows are just my opinions...they are free...just remember you got what you paid for!
WAS PROPOXYPHENE A BAD DRUG?
A fair question, but the answer depends a lot on your definition of the word "bad" in this particular context. Propoxyphene, and especially propoxyphene with acetaminophen, were very dangerous when combined with other sedating medications, tylenol-containing products, or alcohol. I have had numerous customers use this product for years without problems. It helped them. That, of course, does not make it safe. But if you subtract the number of cases in which the drug was intentionally misused, or simply improperly used due to the patients age, drug profile, or health status...I believe that the actual number of adverse events would be significantly less.
DID THE FDA INTENTIONALLY SUPPRESS INFORMATION OR IGNORE DATA?
When something goes wrong, particularly with a prescription medication, we all want to blame someone. I am no fan of the shameful political maneuvering that often goes on in the drug industry. However, removing a drug from the market that has been used successfully in millions of patients, is not something that is done easily. Until just the past few months the FDA still had no reliable data that clearly indicated that propoxyphene could cause heart rhythm abnormalities that would result in clinical adverse events. All the evidence reviewed and brought before the FDA was exclusively about the drug's potential lack of effectiveness in some trials, and the significant impact (sometimes fatal impact) when this drug was used improperly. These are serious. But I do not think the FDA failed to weigh the data.
SHOULD PROPOXYPHENE HAVE BEEN WITHDRAWN FROM THE MARKET?
Given the recent data regarding heart rhythm abnormalities I think it is prudent to discontinue regular propoxyphene marketing in the U.S. An alternative approach would be to allow it with additional monitoring requirements for patients who really cannot use other alternatives. I am sorry for the many patients that this will significantly inconvenience. The reality is that some of the options for pain control that will be prescribed will create a hardship and reduced quality of life for some patients. But the majority will be able to find adequate pain control from other products. Hopefully, the withdrawal will inspire the drug industry to do further research on propoxyphene and possibly discover a similar drug without the same side-effects.
WHAT OPTIONS ARE THERE NOW TO REPLACE PROPOXYPHENE?
If you were taking one of these propoxyphene products and now must consider alternatives, you will need to discuss your options with your physician. Some possible alternatives that might be considered are:
- NSAIDS (non-steroidal anti-inflammatory drugs): Examples include naproxen, piroxicam, meloxicam, ketoprofen, etodolac, etc.
- Tramadol: Tramadol (brand name Ultram) is a unique non-narcotic prescription pain reliever.
- Tylenol with Codeine: Various strengths are available by prescription. This is a Schedule III controlled substance.
- Vicodin/Lortab/Lorcet, etc: These drugs contain a combination of hydrocodone (a cousin of codeine) and acetaminophen.
For a more detailed discussion of alternatives, go to: Alternatives for Darvocet
For more information about the FDA decision, CLICK HERE.