Industry Briefs

FDA Warns of Risk of Serious Skin Reaction Caused by Olanzapine

The Food and Drug Administration (FDA) has issued a warning that olanzapine-containing products may cause a rare but serious skin reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

This inflammatory condition results from an abnormally high number of eosinophils (infection-fighting white blood cells), which produces rashes, fever, and swelling of the lymph nodes and face. The condition can spread to internal organs, potentially resulting in organ damage and death.

There is no specific treatment for DRESS, and the FDA recommends the syndrome is best managed by early recognition, discontinuation of the offending medication, and supportive care.

The FDA recommends that health care professionals prescribing olanzapine make patients aware of the risks associated with the medication and stop treating patients with olanzapine if DRESS is suspected. Any side effects involving olanzapine should be reported to FDA MedWatch.

According to the FDA Adverse Event Reporting System database, 23 worldwide cases of olanzapine-related DRESS have been identified since the drug’s approval in 1996.

FDA Requests More Data for Abilify Pill With Ingestible Tracking Device

The FDA has issued a Complete Response Letter to Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health requesting more data for the novel drug/device combination product that consists of Abilify (aripiprazole) with an embedded ingestible sensor tracking device.

The FDA is specifically asking the companies to provide additional information regarding the performance of the product under the conditions in which it is likely to be used and for more investigations testing the safety and effectiveness of the technology.

The product is intended to measure medication adherence in adults with schizophrenia, manic and mixed episodes with bipolar I disorder, or major depressive disorder.