Safety Alerts & Recalls

What does this mean?

You should continue to take your medicine as directed by your doctor. The benefits of olanzapine treatment will outweigh the risk of the rare skin reaction DRESS for most people. For olanzapine to work properly, the medicine should be taken every day as prescribed. Do not stop taking olanzapine or change your dose without first talking to your health care professional. Sudden stopping of the medicine without your healthcare provider’s direct supervision can be harmful.

However, please be aware that a rare skin reaction may occur with the use of olanzapine. Patients can also develop a fever, rash, swollen lymph nodes, or swelling in the face. The combined symptoms together are known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Call your health care provider and seek immediate medical care if you develop any of the following symptoms:

--Skin rash

--Fever

--Swollen face

--Swollen lymph gland

Please read the patient Medication Guide you receive along with your olanzapine prescriptions, which explains the risks associated with the use of olanzapine. If you have any questions or concerns about olanzapine, please discuss them with your healthcare provider

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

FDA Warns About Rare But Serious Skin Reactions with Mental Health Drug Olanzapine

The U.S. Food and Drug Administration (FDA) has issued a warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. This severe condition is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). This new warning about the rare risk of DRESS will be added to the prescribing information for all olanzapine-containing products.

DRESS may start as a rash that can spread to all parts of the body. It can include fever and swollen lymph nodes and a swollen face. It causes a higher-than-normal number of infection-fighting white blood cells called eosinophils that can cause inflammation, or swelling. DRESS can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. DRESS is a potentially fatal drug reaction.

Olanzapine is an antipsychotic medicine used to treat mental health disorders schizophrenia and bipolar disorder. It can decrease hallucinations, in which people hear or see things that do not exist, and other psychotic symptoms such as disorganized thinking. Olanzapine is available under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and also as generics.

For more information, please visit: more information here

Source: FDA
Publication Date: 2016-06-01
Last Updated: 2016-06-02

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