Improved
6112 HealthChanged
3786 LivesSaved
3568 Lives0 lives impacted in the last 24 hrs Learn More
The United States Food and Drug Administration has banned medicines containing propoxyphene from the U.S. market. Propoxyphene is an opioid used as a painkiller and often in combination with other drugs such as acetaminophen, for the control of mild to moderate pain.
The FDA first approved it in 1957 to be used singularly or in combination with other painkillers and was declared safe.
However, by 1978 they had received two public petitions calling for its withdrawal or at the very least, re-classification as a more potent drug. This was because the painkiller was proving addictive and had caused serious adverse events in some people who took it, but the FDA ignored the petitions because it said the benefit of the painkiller outweighed any risk. With the many other products available for mild to moderate pain that didn’t have such adverse associations, it is surprising that they didn’t err on the side of caution since their role is to protect the public.
The drug continued being marketed and sold to members of the public and the issue was not looked at again, until evidence of cardiac problems surfaced in 2009. In a January meeting that year, 14 members of the 26 member meeting, voted against continued marketing of propoxyphene but nothing was done and six months later the FDA announced it would continue to market the drug.
It wasn’t until the supplier of the drug had conducted a study to prove its safety and found that even when it was taken at recommended doses, it changed the electrical activity of the heart, that they decided it wasn’t safe after all.
Adverse events between 2006-2007 included psychiatric complications, cardiac complications, accidental drug overdose and death. Some overdoses were thought to be related to the addictive properties of the drug, leading patients to take too much because of dependence on it. In total there were 65 serious adverse events in that period.
In elderly people the risk was greater and over one third of the reactions reported in people over 65 years of age were psychiatric and included hallucinations, confusion and mental status changes.
Some adverse events occurred due to the interaction of the drug with other drugs. Taking propoxyphene with other medications may in some cases increase the concentration of the drug, making it dangerous.
There was also an increased risk of death when this product was taken alongside anti-depressants.
The UK withdrew propoxyphene painkillers in 2007 due to 400 deaths caused by overdose, one in five of them accidental.
Despite this, the FDA has only just recommended the withdrawal of the drug, over 50 years too late.
Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunisation,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.
Add a Comment1 Comments
This article makes me think of a more recent story. It’s interesting you mentioned acetaminophen early in your article and how it was thought that combining these drugs would prevent side effects. While propoxyphene is being banned, the FDA is giving increased attention to the safe use of acetaminophen / Tylenol since it has been linked to liver damage and death due to accidental overdose. It will be interesting to see how they continue to monitor and regulate these drugs that have benefits, but might also present serious health risks.
November 22, 2010 - 11:10amRegards, TL, http://www.liverfailurefromtylenol.com
This Comment