Darvon: 53 Years of Profits Over People

by Robert Schwartz

Darvon and its generics that contain propoxyphene have been in American homes since 1957.  An opioid pain reliever used to treat mild to moderate pain, Darvon has had 15 label changes warning of serious side effects up through the end of 2009.  Label changes occur because of increased reports of serious side effects, whether those side effects are seen in scientific studies or in doctors’ offices.

In 2009, the seriousness of these side effects caused the Food and Drug Administration (FDA) to require the manufactures to revise the warnings on Darvon to include a Black Box Warning, the strongest warning possible on a prescription drug.  Black Box Warnings are at the very beginning of the label, are usually in bold print, have a bold border around them, and warn of the most serious and dangerous side effects of the drug.  Drug companies do everything in their power to avoid having to put a Black Box Warning on a drug because prescriptions for that drug will dramatically decrease and the drug company will make less money.  On or about July 7, 2009, the FDA notified doctors that it was taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. That is why the FDA required the Black Box Warning, emphasizing the potential for overdose when using these products, and providing a medication guide to patients stressing the importance of using the drugs as directed.

Last month, the FDA notified doctors that manufacturers of Darvon and its generics have agreed to withdraw Darvon due to new data showing that the drug can cause serious toxicity to the heart, even when used as directed.  The critical point in the FDA’s decision to “ask” that the drug be withdrawn is its conclusion that the safety risks outweigh its benefits for pain relief at recommended doses.

The serious side effects that last month pushed the FDA over the edge did not just appear.  As with the serious side effects that caused the FDA to require a Black Box Warning, these side effects have occurred and been reported to the manufacturers for the last 53 years!  Thousands of people have been injured and killed by this drug over that half century.  For the past 30 years, many new pain relievers that are better and safer alternatives to Darvon have been approved and put on the market.  So why have the manufacturers fought so hard to keep the Black Box Warning off Darvon’s label?  Why did it take so long for the FDA to require this dangerous drug be withdrawn from the market?  Profits.  These manufacturers have made millions of dollars from Darvon over its 53 years.  Even today, after the “voluntarily” withdrawal of Darvon from the market, the manufacturers will never admit that Darvon’s risks outweigh its benefits.   They will never concede that Darvon hurt anyone.  They will always find an excuse for what happened to those people who have been injured or killed by this drug.  They will point to the innocent victims’ medical history, family medical history, prescribing doctor or some other pharmaceutical the victim was taking at the same time.  Just as casually as they failed to warn the medical profession and patients of all of Darvon’s dangers, they will dismiss responsibility for these injuries, damages and deaths, saying everyone knows that all drugs have side effects.

The drug industry has to make full and complete warnings of all known side effects, even if doing so affects the bottom line.  Companies need to stop putting their profits ahead of the safety and welfare of the people who innocently take their dangerous drugs.

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