A warning on the antipsychotic medicine olanzapine that can cause a “rare but serious” condition has been issued by The U.S. Food and Drug Administration (FDA). Olanzapine is available under the Eli Lilly & Co. brand names of Zyprexa, Zyprexa Zydis, Zyprexa Relprevv and Symbyax as well as generics, and is used in the treatment of schizophrenia and bipolar disorder, reports Law360.
The FDA announced it is adding a new warning to the drug labels for all olanzapine-containing products telling consumers it can start as a rash and result in organ injury. Olanzapine can cause a potentially fatal skin reaction that can progress to affect other parts of the body.
Since 1996, when the first olanzapine-containing product was approved, FDA’s database identified 23 cases of the skin reaction. The database includes only reports submitted to the FDA, so there may be additional cases about which the agency is unaware, according to the FDA’s notice.
After the death of two patients following injections of Eli Lilly’s schizophrenia drug Zyprexa Relprevv in 2013, an investigation was opened by the FDA, saying the deaths were unexplained, but the two patients had “very high” levels of the active ingredient olanzapine in their blood.
In 2008, the FDA issued a word of caution concerning the excessive sedation connected to a long-form version of Zyprexa, revealing a “mixed bag” regarding the effectiveness and potential side effects of the injectable formulation.
In May 2016, the New Jersey Appellate Division refused to revisit a woman’s claim that the drug company failed to sufficiently warn her of the drug’s side effects, ruling that the patient didn’t prove that the medication caused her weight gain and diabetes, Law360 reports.