FDA Pulls Painkillers From Market After Tests Confirm Fatal Heart Rhythm Problems

By November 23, 2010 Dangerous Drugs

Last week, I wrote about a prescription painkiller that some defective drug lawyers believe should be pulled from the market because of the risk of overdose. This week, a painkiller is in the national spotlight for even more serious problems — a risk of fatal health complications from intended use, not overuse. As ABC News reported Nov. 19, the U.S. Food and Drug Administration has asked the maker of Darvon (propoxyphene) and Darvocet (propoxyphene plus acetominophen) to take the drugs off the U.S. market because studies have shown that they can cause serious or fatal heart rhythm abnormalities. Generic drug makers are not obligated to take their own versions off the market, although the FDA has requested this. All versions of the drug have already been withdrawn in the United Kingdom, the European Union and New Zealand, and are strictly regulated in Sweden.
Propoxyphene is a painkiller in the opioid class, which means it’s from the same family of drugs as powerful prescription painkillers as well as opium and heroin. Like many other drugs in its family, it has a high addiction potential and is sometimes illegally used as a recreational drug. However, it is considered weak compared to many other prescription painkillers. Safety groups have cited some of those facts as reasons for withdrawing propoxyphene from the market, but they have also criticized the drug as more likely to cause fatal complications than other, more effective painkillers. An FDA panel voted in January of 2009 to take propoxyphene off the market, but the agency delayed action until a clinical trial in humans showed that the drug disrupts the electrical impulses that keep the human heart beating. A review of safety studies also showed more deaths per 10,000 patients with propoxyphene than with comparable drugs tramadol and hydrocodone.
As a pharmaceutical liability attorney, I’m pleased that the FDA has taken action to protect consumers from the bad effects of this drug. As the agency itself said publicly, the heart arrhythmia problems make it clear that the benefits of the drug do not outweigh its risks. However, I am disappointed that it took the FDA so long to take action after its panel voted to take propoxyphene off the market in January of 2009. It has been nearly two years since then, and Public Citizen estimates that statistically, 1,000 to 2,000 Americans may have died from using the drug during that time. Indeed, even that vote came after some overseas regulators had already banned it. No doubt the makers of Darvon and Darvocet stood to make money during that time as well — but the FDA is not in the business of helping drug manufacturers make a profit, particularly at the expense of public safety.


In fact, drug manufacturers frequently stand to make a profit at the expense of patients’ health, which is why we have a special dangerous medications practice at Carey, Danis & Lowe. Our dangerous prescription drug lawyers represent clients who lost a family member or were seriously injured or sickened by a drug they thought they could trust. Medications are supposed to make us feel better, but when drug makers don’t do enough safety testing — or fail to disclose risks to the public — they can actually harm us, sometimes far more than the original problem did. We help patients and their families hold drug manufacturers legally liable for that type of harm. In addition to allowing victims a measure of justice, these claims can help families recover compensation for their medical bills, lost quality of life and many other financial and personal injuries.
If you or someone you love was seriously hurt by taking a prescription drug you trusted, don’t hesitate to call Carey, Danis & Lowe. Based in St. Louis and Belleville, Ill., we represent clients around the United States. To learn more or set up a free consultation, contact us through our website or call toll-free at 1-877-678-3400 today.