A few hours of extreme drowsiness is not a bad trade-off for schizophrenia patients who have problems sticking to their medication. So said an FDA advisory committee yesterday in backing approval of Eli Lilly's new long-acting, injectable form of Zyprexa.
The advisory panel said that Zyprexa LAI was "acceptably safe" for use in patients with a history of not taking their meds. That's despite the fact that it caused "profound sedation" in some--so severe, in a few cases, that patients lost consciousness or fell into a coma. The sedative effect was seen in 24 of 2,045 patients studied.
Lilly is proposing a risk-management program under which patients would be observed for an hour after receiving the injection, and would be instructed to have friends or family members monitor them for another two hours so they could get medical attention if necessary.
This long-acting form of Zyprexa also causes weight gain, changes in blood sugar, and high cholesterol--the same side effects seen in the oral form.
- see Lilly's release [1]
- read the report [2] from CNN Money
Related Articles:
Lilly settlement leaked in errant email. Report [3]
Shareholders sue Lilly over Zyprexa. Report [4]
Lilly could pay $1B to settle on Zyprexa. Report [5]
Zyprexa--Top 10 Warnings and Recalls of 2007. Report [6]
Links:
[1] http://www.fiercebiotech.com/press-releases/fda-advisory-committee-supports-efficacy-and-safety-zyprexa
[2] http://money.cnn.com/news/newsfeeds/articles/djf500/200802062009DOWJONESDJONLINE000898_FORTUNE5.htm
[3] http://www.fiercepharma.com/story/lilly-settlement-leaked-in-errant-email/2008-02-06?utm_medium=nl&utm_source=link
[4] http://www.fiercepharma.com/story/shareholders-sue-lilly-over-zyprexa/2008-02-01
[5] http://www.fiercepharma.com/story/lilly-could-pay-1b-to-settle-on-zyprexa/2008-01-31?utm_medium=nl&utm_source=link
[6] http://www.fiercepharma.com/special-reports/3-zyprexa-top-10-warnings-and-recalls