Decommissioning Darvon

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  • 02/02/2009
Here's the black box warning that has been attached to Darvon and it's generic version's for years:

"Darvon should not be used by people who are suicidal or who easily become addicted to medicines, alcohol, or other substances. Do not take more of Darvon than the dose your doctor prescribed. Taking excessive doses of Darvon by itself, with other medicines, or with alcohol may cause serious side effects and could be fatal. Limit the amount of alcohol you drink while you are taking Darvon . Tell your doctor if you have a history of any substance abuse, mood or mental disorders, suicidal thoughts or attempts, or if you take any medicines that cause drowsiness such as tranquilizers, sleep medicines, muscle relaxers, or antidepressants."

And here is an Time Magazine article about Darvon and the efforts of Sid Wolfe, now an offical pain the you know what as a member of the Risk Benefit advisory committee for the FDA, to ban the drug:

"... Wolfe asked for an immediate ban on the sale of the widely prescribed pain reliever propoxyphene, best known as Darvon. He claimed not only that Darvon is an ineffective painkiller, but also that in excessive doses it produces a euphoric high, which he says, "makes it attractive as a drug of abuse. This is tantamount to legalized dope." Further, said Wolfe, Darvon-related deaths in the U.S. have been increasing, rising in major cities to about 600 last year and making the compound "the deadliest prescription drug in the United States." Eli Lilly and Co., of Indianapolis, the principal manufacturer, promptly branded Wolfe's charges "irresponsible and clearly not supported by the facts."

Darvon-related deaths have often involved intentional misuse, either by overdosing or mixing with alcohol and other drugs. Lilly notes that the average person would have to take 30 large-size Darvon capsules at one time (the usual dose is one every four hours) to cause death, 15 if he were intoxicated. Further, the drug is a controlled substance—a prescription is good for only five refills within six months. (If HEW will not ban Darvon, Wolfe wants the drug reclassified so that prescriptions cannot be refilled.)

Lilly also says that Wolfe's claim about Darvon's effectiveness is misleading because it is largely based on studies of single, rather than multiple, doses of the drug. Doctors prefer Darvon for some patients because, unlike aspirin, it does not cause gastrointestinal bleeding or lower the body temperature. Concludes Lilly's Dr. Robert Furman: "Used as directed, Darvon is really very safe. The fact that some people are intent on abusing it shouldn't be used to indict it."

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That article was written 40 years ago. Wolfe was petitioning the FDA then.

I can't say I totally disagree with Wolfe's motives. Darvon and Darvocet were and are the drug of choice for people who seek to commit "peaceful suicide' and is pushed as such by pro-suicide groups and chat rooms. The problem is, banning the drug will remove another effect medicine for menstrual cramps that does not cause internal bleeding and if the UK is any guide those seeking to commit suicide or use painkillers recreationally will use medicines that are stronger or have worse side effects than liver toxicity.

Wolfe's persistence is an example of ideology overriding science and the doctor-patient relationship. The Sid Wolfe fan club (Alicia Mundy, President) might delight in his longstanding effort to drive drugs he detests off the market but for many people, including me and family members, his personal choices would come at the expense of our very lives.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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