It has been a few years, but the FDA’s war on antiemetics (medications for vomiting) continues.
To review …
Bendectin was the first antiemetic to be taken off the market after famous plaintiff attorney Melvin Belli sued Merrell Dow Pharmaceuticals. No credible evidence was ever found that Bendectin caused birth defects as the plaintiff attorneys alleged, yet Merrell Dow removed bendectin from the market to avoid further lawsuits.
Droperidol was another great nausea medicine that got the FDA’s dreaded “black box” because it allegedly caused QT prolongation. See commentary here.
Then the FDA went after Tigan suppositories. Remove them from the market, it demanded.
Compazine was next to get the dreaded “black box” kiss of death.
Then came Reglan, which joined the “black box” club due to a risk of tardive dyskinesia. Interesting that one of the medications that has been used to treat tardive dyskinesia is another antiemetic … Zofran.
Phenergan was next. In Wyeth v. Levine, a Vermont jury decided that drug labeling warning against intra-arterial use wasn’t strong enough. The resulting black box warning struck fear into the hearts of hospital risk managers everywhere. By the way, how many of you knew that Phenergan is an antihistamine and, like Benadryl, can be used as a local anesthetic?
It appears that not enough people were scared off by the previous FDA warning on Zofran, though.
Now, the FDA has decided the 32 mg IV dose of Zofran has the “potential for serious cardiac risks” and is demanding removal of all 32 mg IV Zofran doses from the market. Those same cardiac risks – QT prolongation – were used to get droperidol black boxed, so it is only a matter of time until Zofran gets its scarlet letter from the FDA.
Personally, I would like to see the FDA’s studies on Zofran … and all the other antiemetics for that matter. I seriously doubt many of the claims.
In the meantime there’s always Aprepitant. That’s only $100/dose (in 2004). Plus … the FDA won’t determine that it’s bad for your health for at least another 10 years – about the time it goes off patent.