-blog.wsj.com
03/02/2008 - Even as Eli Lilly’s lawyers are getting ready to defend a Zyprexa case in Alaska, the company’s got bad news from the FDA, four time zones away. The agency refused to approve the company’s application for a long-acting form of the anti-psychotic drug the company said this morning.
An advisory committee recently voted in favor of the drug, though it noted concern over “profound sedation” that occurred for a few hours in a small number of patients who received the injected drug.
At the time the advisory committee met, all of the reported cases of profound sedation had occurred within three hours of the time the patient received the drug. But in a recent case that hadn't been fully investigated when the committee met, the sedation came on between three and five hours after the patient received the drug. The FDA cited this case in the non-approvable letter it sent to Lilly, the company said.
Meanwhile, in Alaska, the company’s getting ready to go to court next week in what the WSJ says will be its first civil suit over the regular form of Zyprexa. The state’s attorney general accuses the company of failing to warn patients of the drug’s side effects, which include weight gain and the risk of diabetes. And the AG says the company made deceptive claims in marketing the drug, improperly driving up use (and the state’s cost in buying it for Medicaid patients).
The trial will be closely watched, because it could have an effect on the megasettlement the company’s reportedly negotiating with the feds and a bunch of state attorneys general.
High levels of sugar in the blood, also known as hyperglycemia, is a common finding in individuals taking atypical anti psychotics who are thought to have normal blood sugar levels.
Over a 2-year period, Dr. Michael J. Sernyak, of the VA Connecticut Healthcare System, New Haven, Connecticut, and colleagues examined the frequency of undiagnosed high blood sugar in 647 patients taking atypical anti psychotics, including Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), or Geodon (ziprasadone). Of these subjects, 153 had a fasting blood sugar result.
The investigators found that blood sugar levels were normal in 70 percent subjects, elevated in 25 percent and very elevated in a little more than 5 percent. No significant differences in race, ethnicity, age, body mass index or psychiatric diagnosis were observed between those with normal and patients with abnormal blood sugar results.
When the authors analyzed the antipsychotic medications prescribed, they found that significantly more patients receiving Clozaril were in the elevated blood sugar group than in the normal blood sugar group. No significant differences were observed for any of the other medications.
The authors say the finding that nearly one in three patients receiving atypical anti psychotics who are thought to have normal blood sugar levels actually have "demonstrable and clinically significant abnormalities" of glucose metabolism argues for periodic screening in even large outpatient populations."
SOURCE: Journal of Clinical Psychiatry December 2005.
If you are currently taking Zyprexa and have concerns about its safetly, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Zyprexa, without first consulting with your doctor. For Zyprexa legal information contact the Zyprexa Attorneys of Ennis & Ennis, P.A. by filling out our free Zyrpexa case evaluation form or by calling the toll-free number listed below.
