#FDAwarns about rare but serious skin reactions with olanzapine.

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

Facts about Olanzapine  

  •  Olanzapine is an atypical antipsychotic medicine used to treat schizophrenia and bipolar disorder (manic or mixed episodes).  For bipolar disorder, olanzapine can be used alone or in combination with other drugs.
  •  Olanzapine can decrease hallucinations, in which people hear or see things that do not exist, and other psychotic symptoms such as disorganized thinking. Olanzapine can also decrease the mania of bipolar I disorder.
  • Olanzapine is marketed under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and as generic products.
  •  Olanzapine and fluoxetine are marketed as a combination product under the brand name Symbyax and as generics for the treatment of depressive episodes associated with bipolar I disorder, as well as for depression that has not been successfully relieved by other treatments.
  • Common side effects of olanzapine include sleepiness, tiredness, weight gain, increased appetite, low blood pressure, dizziness, muscle stiffness, restlessness, constipation, dry mouth, and tremor or shakiness.
  • In 2015, approximately 4.1 million prescriptions for oral olanzapine were dispensed and approximately 849,000 patients received a dispensed prescription for oral olanzapine from U.S. outpatient retail pharmacies.

Patients taking olanzapine-containing products who develop

  • a fever with a rash
  • swollen lymph glands,
  • swelling in the face,

should seek medical care right away.

  • The combined symptoms together are commonly seen in DRESS.
  • Talk with your health care professional about any questions or concerns.
  • Do not stop taking olanzapine or change your dose without first talking with your health care professional.
  • Sudden stopping of the medicine can be harmful without your health care professional’s direct supervision.

 Information for Health Care Professionals 

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a rare and severe skin reaction accompanied by eosinophilia and systemic signs and symptoms, has been reported in patients treated with drugs that contain olanzapine.  Patients may develop fever with rash and lymphadenopathy.

  • Features of DRESS can also include hepatitis, myocarditis, pericarditis, nephritis, pancreatitis, and pneumonitis.
  •  A new warning to describe DRESS will be added to the labels of all olanzapine- containing drugs.
  • When prescribing olanzapine, inform patients about the risk of DRESS, a severe skin reaction that can occur with treatment.
  • Explain the signs and symptoms of DRESS to your patients and tell them when to seek immediate medical care if signs and symptoms occur.
  • DRESS consists of three or more of the following:
    • Cutaneous reaction (such as rash or exfoliative dermatitis)
    • Eosinophilia
    • Fever
    • Lymphadenopathy
    • One or more systemic complications such as hepatitis, myocarditis, pericarditis, pancreatitis, nephritis, and pneumonitis
  • If DRESS is suspected, discontinue olanzapine treatment immediately.
  • DRESS is a potentially fatal drug reaction with a mortality rate of up to 10%.
  • The pathogenesis of DRESS is unclear; however, it is thought to be the result of   a combination of genetic and immunologic factors, such as detoxification defects in the drug metabolism pathway, resulting in toxic metabolite formation and an immune response.  Reactivation of viral infections (herpes virus [HHV-6 or     HHV-7]) or Epstein-Barr virus (EBV) may also play a role by inducing or amplifying the immune reaction.
  • There is currently no specific treatment for DRESS.  The important ways to manage DRESS are early recognition of the syndrome, discontinuation of the offending agent as soon as possible, and supportive care.
  • Treatment with systemic corticosteroids should be considered in cases with extensive organ involvement.
  • Report adverse events involving olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and generics), or other medicines.

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.

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.