Accutane Finally Removed From the Market Proving Again That Lawsuits Are the Last Line of Defense Against Unsafe Drugs

Over the weekend Roche Holding, the maker of the dangerous acne drug Accutane took it off the shelves.  This is a development that consumer groups have been calling for for years (as noted in Center for Justice & Democracy’s report, The Bitterest Pill, How Drug Companies Fail to Protect Women and How Lawsuits Save Their Lives.) 

 Here’s how the Associate Press reported it:

The decision was made for economic reasons, not safety reasons, the company said. The drug has a rocky safety history, having been linked to birth defects if taken during pregnancy, along with depression and suicidal thoughts. The company said costs for personal-injury lawsuits are high, but it continues to "rigorously" defend the drug.

In other words, despite how the company puts it, when all else failed, lawsuits finally worked to get this drug off the market.

Indeed, as CJ&D noted in its report, drug has had a long history of medical problems associated with its use and could have as many as 5,000 pending lawsuits against the company.

As early as the late 80’s the FDA was considering removing the drug from the market because of the more than 2,000 documented cases of miscarriages and children born with severe birth defects.  Even so, the drug remained available, with increasingly severe – but ineffective – warnings against taking the drug while pregnant. 

There has also been extended public discussion about the drug’s link to suicide after the suicides of B.J. Stupak, the teenage son of U.S. Representative Bart Stupak, (D-Mich.) who shot himself in 2000, and Charles J. Bishop, the 15-year old who flew a plane into a Florida building in January 2002.  Later that year a congressional oversight committee’s two-year investigation into the health effects and regulatory control of Accutane concluded that the drug had frequently been associated with suicide.

Eleven other countries have already removed the drug from their shelves.

Comments

[Caitlin]

While I understand the risks and dangers of this drug, I have to say that I am very grateful that I was able to use it before it went off the market. Its been 9 years since I was on it but I still will never forget the horrors of living with acne as bad as mine. I have Crohn's Disease--which has not been linked with this drug. But at this point, if it was, I'm not sure I wouldn't say it was a fair trade.