Injectable Zyprexa Causes Major Sedation

Thanks to those who've alerted me on news of the FDA's concern that the up-for-approval injectable version of Zyprexa called Adhera has triggered concerns by the FDA that the drug causes profound sedation in about 1 percent of patients who went through clinical trials for Eli Lilly, the drug's maker. Adhera is set for a hearing on Feb. 6 before the FDA's Psychopharmalogic Drugs Advisory Committee.

One of the studies Lilly submitted for approval of the drug was eight weeks, the other was a 24-week maintenance study. I am a bit confused that sedation may have been the only notable side effect to show up in these studies. Approximately 35 percent of patients getting this new drug gained over 7 percent of their body weight in a short period of time, according to the FDA's packet for the hearing. That percentage is triple the number of patients receiving placebo who gained that much weight and is right in line with the percentage of patients taking Zyprexa in pill form who packed on the pounds.

The fact that the FDA has not flagged this for the committee as a safety concern is simply bizarre. You can read the FDA's full background packet on the drug here (1.6 MB .pdf).

Via Pharmalot and the Wall Street Journal.