Darvon and Darvocet die a slow death

The prescription drug that comprises Darvon and Darvocet, generic name propoxyphene, has finally been recalled by the brand name and all generic manufacturers.  It was a long time coming.  Propoxyphene has long been associated with many untoward side effects, the most dangerous of which is liver damage.  Additional MINOR side effects include constipation; dizziness; drowsiness; lightheadedness; nausea; vomiting.
SEVERE side effects that occur when using propoxyphene are severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; cold or clammy skin; confusion; excessive sweating; hallucinations; loss of appetite; loss of consciousness; mental or mood changes; seizures; severe drowsiness or dizziness; severe or persistent stomach pain; vision changes; weakness; yellowing of the skin or eyes.


These side effects have been known for years since the drugs approval by the Food and Drug Administration (FDA) and introduction to the market by Lilly in 1957.  Considered to be in the opioid class of pain relievers, there have been many safer alternatives available, namely aspirin, acetaminophen, codeine, morphine, hydrocodone and the entire class of opioids.  Many people who are allergic to some opioids were not allergic to propoxyphene.  That spurred its use despite a limited and low therapeutic pain relief index.  Most of those people would have found enough pain relief from plain aspirin of acetaminophen, the active ingredient in Tylenol.


The FDA allowed the drug to stay on the market in 2009, despite a panel of experts who conducted a safety review, and voted 14-12 against doing so.  In a half-hearted attempt to save face, the FDA required drug-makers to add a warning to packaging, which stated that taking too much of the drug could be fatal.  The results of the most stringent testing showed significant changes to the electrical activity of the heart.  Those changes are linked to potentially deadly abnormal heart rhythms.


The bottom line is that the FDA does not have the best interests of the public in mind if it continues to allow drugs to be marketed that cause dangerous side effects.  One death is too many.  The FDA has been a boon to plaintiff lawyers who sue the drug companies for these infractions.  Unfortunately, the amount the drug companies pay out to the few plaintiffs who do bring suit is much lower than the money they have made during the lifetime of the drug on the market, and thus people will continue to be harmed needlessly.