The FDA has warned of a rare but serious skin reaction that can be progressive with the antipsychotic drug olanzapine and related products.
The agency is adding a new warning to all olanzapine-containing products about the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), according to a .
Affected products include olanzapine brand name drugs Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, as well as generics.
The FDA identified 23 cases of DRESS with olanzapine since 1996 in its Adverse Event Reporting System (FAERS). The agency cautioned that the database includes only reports submitted to FDA, "so there are likely to be additional cases about which FDA is unaware."
There was one death in a patient taking olanzapine who developed DRESS, but this patient was taking multiple drugs that could also have contributed to the death, the agency said.
DRESS may start as a rash that can spread to all parts of the body and can include fever and swollen lymph nodes and a swollen face. It causes an increase in the number of eosinophils which leads to inflammation.
The condition can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and its mortality rate is up to 10%, the FDA said.
The agency called for patients who are taking olanzapine and develop a fever with rash and swollen lymph glands or facial swelling to seek medical care immediately, and physicians should stop therapy right away if DRESS is suspected. But the agency warned that patients shouldn't stop taking their medications without seeking the advice of a doctor.
Currently there is no specific treatment for DRESS, and FDA recommends best supportive care, including treatment with corticosteroids in cases with extensive organ involvement.
Physicians are also encouraged to report adverse events to the FDA's AERS system .