The browser doesnot support javascript
Print Plan Forms | Help

Medication Safety Alerts

Olanzapine MedWatch

05/10/2016


On May 10, 2016, the United States Food and Drug Administration (FDA) issued a MedWatch warning that olanzapine-containing medicines can cause a rare but serious skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) that can affect other parts of the body. Olanzapine is available under the brand names Zyprexa®, Zyprexa® Zydis®, Zyprexa Relprevv®, and Symbyax®, and also as generics.

The FDA has provided the following information for plan members:

  • Treatment with olanzapine may cause a rare but severe skin reaction that can spread to cover much of the body. 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).
  • A new warning to describe DRESS will be added to the labels of all medicines containing olanzapine.
  • Call your health care professional(s) and seek immediate medical care if you develop any of the following symptoms:
  • Skin rash
  • Fever
  • Swollen face
  • Swollen lymph glands
  • 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 doctor. Sudden stopping of the medicine can be harmful without your doctor’s direct supervision.
  • Read the patient Medication Guide you receive along with your olanzapine prescriptions, which explains the risks associated with the use of olanzapine.
  • Discuss any questions or concerns about olanzapine with your doctor.
  • Report any side effects from olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and generics), or other medicines to your doctor and the FDA.

CVS Caremark Response: Please note: There have been no recalls issued on these products. CVS Caremark will continue to dispense these products.

If you are currently taking olanzapine-containing medicines and have questions, please call your doctor or call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit http://www.fda.gov/Safety.

The CVS/caremark™ app lets you manage your prescription benefits on the go. Download it now:

CVS Health LogoCVS Pharmacy LogoCVS Minute Clinic LogoCVS Specialty LogoSilverscript LogoAccordant Logo

Copyright © 2018 CVS/caremark. All rights reserved| Terms and Conditions | Privacy Policy | Accessibility | Member Rights & Responsibilities