“Death Drug” Finally Off the Market

Here’s something to wonder about. A drug approved in 1957 (that’s right, more than fifty years ago) has finally been recommended for removal from the U.S. marketplace. The wonderment comes in when you think about how many people may have been adversely affected by the medication.

Propoxyphene Napsylate, sold in the U.S. under the trade names Darvon and Darvocet, wasn’t actually recalled – even though there was evidence that the pain medication caused heart arrhythmias. It was only “recommended” by the FDA that manufacturers quit selling it. Partly, this was because of the addictive nature of the drug. Allowing it to be sold (with a strong warning) would let doctors have a chance to either wean their patients off of it (if they were hooked) or switch them to another product.

The concern comes from two criticisms. Although the first FDA vote to remove it from sale came in July of 2009, only a warning was added to the labeling at that time. It wasn’t until mid-November of this year that the drug was no longer being sold. In that time, both Britain and Europe overall stopped the sale of propoxyphene, leading to an estimated one to two thousand unnecessary deaths in the States.

The death drug reputation

In hindsight it isn’t surprising that this medication, which had the same restrictions as Tylenol with codeine, was popular as a “death drug.” Organizations that advocate suicide for terminal illness were mentioning it for years – it was easier to get than the more restricted barbital type meds and just as deadly (or more so) when people intentionally overdosed on it.

The current information is that unintended deaths on this medication were not just the result of accidental overdose, but also from heart rhythm problems the drug caused. This particular adverse effect went unmentioned for the 50 years the drug had been marketed. To make matters worse, it was considered a good alternative to codeine containing products in people with a genetic variant that didn’t allow them to get the full benefits from codeine.

The legal outlook

While there is certainly a good case to be made for anyone who died from a heart rhythm disorder in the past year (since the information about risks has been available) it is unknown how difficult it will be to place the blame directly on this drug. Even though a study in dogs that goes back to the 70’s showed cardiac abnormalities, no follow ups were required by the FDA and, in fact, they delayed their removal recommendation until more human data became available – this was the rationale for the year-long delay from July of last year.

A quick phone check of Billings’ hospitals shows they haven’t had the drug on their formularies (the list of drugs they carry) for some time. The toxicity risks have been known in the medical community, even while it was still being prescribed by physicians outside of the hospital environment.

An excellent report by the Public Citizen tells the tale of requests made in 1978 and again in 2006 to have the drug recalled.

Even with this clear evidence of probable negligence, it can be extremely hard to pin down whether any individual patient actually died from the drug or another cause. Statistically, we know that people did die, but which? It remains to be seen whether a class action lawsuit or wrongful death suit will succeed against either the name brand or generic manufacturers.

Comments (0)

Post Your Comment:

Name

Email

Title

Comment

smaller | bigger

I have read and agree to the Terms of Usage.

Write the displayed characters

Add Comment