FDA Urges Caution for Olanzapine
May 10, 2016 – The U.S. Food and Drug Administration (FDA) released a Drug Safety Communication to caution that using the drug olanzapine has been associated with a rare, but potentially very severe adverse reaction. Since it was first approved 20 years ago, a few patients using olanzapine have developed drug reaction with eosinophilia and systemic symptoms (DRESS). Usually beginning with a rash, fever and swelling in the face, lymph nodes or both, DRESS is characterized by increased numbers of eosinophils, which are white blood cells involved with regulating inflammation and immune function. DRESS can cause inflammation throughout the body. Among the olanzapine-related cases reported to FDA, one patient died; 22 others suffered serious heart, kidney, liver, lung or other internal organ damage. Dosing does not appear to be a major factor -- doses as low as 5mg caused DRESS for some of the affected patients. The average time to onset of symptoms was slightly less than three weeks after olanzapine was started. An antipsychotic medication that is used to treat bipolar disorder and schizophrenia, olanzapine is available as generics and it also is sold under the brand names Symbyax® (fluoxetine/olanzapine) and Zyprexa®. It has both oral and injectable forms. Presently, DRESS has no specific treatment other than discontinuation of the drug that is causing it. FDA now requires manufacturers to put a warning about the possibility of DRESS on the labels of all products that contain olanzapine. Patients are advised to get medical attention right away if they get a fever or rash while taking it. Doctors who suspect a patient might have DRESS should stop olanzapine immediately.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.