FDA warning links olanzapine antipsychotics to potentially fatal skin reaction risk

by Jim Orr

The Food and Drug Administration has issued a warning that the drug Zyprexa and other antipsychotic medications containing the active ingredient olanzapine may cause a serious and potentially fatal skin reaction known as “Drug Reaction with Eosinophilia and Systemic Symptoms” (DRESS). The agency says that it will add a new warning about the risk of DRESS to the drug label for all olanzapine medications, including Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, Symbyax, and generic versions.

According to the new FDA warning, DRESS may start as a rash or skin reaction that can spread to other areas of the body. Patients who develop this condition may experience fever, swollen lymph nodes, or swelling in the face. Patients may also experience a high white blood cell count known as eosinophils, which can also cause swelling.

Patients who are diagnosed with DRESS while using olanzapine may suffer damage to major organ systems, including the liver, kidneys, heart, lungs, or pancreas, which may lead to death. The FDA estimates the mortality rate of patients who develop DRESS at 10%.

The antipsychotic medication olanzapine was first approved by the FDA in 1996 to treat patients with schizophrenia or bipolar disorder. Patients taking olanzapine may experience a decrease in hallucinations or other psychotic symptoms, such as disorganized thinking.

The FDA says that since olanzapine was approved by the agency, it has received reports of 23 cases of DRESS that have been linked to the drug. The agency says that because its adverse events reporting system is voluntary, the total number of DRESS cases linked to olanzapine medications is likely to be much higher than the number of reports it has received.

The FDA has advised patients taking Zyprexa or other olanzapine medications to seek immediate medical attention if they develop a fever, rash, and swollen lymph glands in combination, or facial swelling, which could be symptoms of DRESS. Although there is currently no specific treatment, doctors may be able to administer medications to patients who are diagnosed with DRESS to prevent organ damage and to minimize the other symptoms of the skin condition.

Pharmaceutical Liability Lawsuits Filed by HO&P

Despite the efforts of the FDA and other federal regulators, thousands of patients are injured every year as a result of side effects from prescription medications. Far too often, the drug industry puts profit ahead of patient interests, disregarding the safety concerns because of the enormous sales that “blockbuster” drugs and medical devices can generate.

If you or a loved one have been harmed by complications from prescription medications such as olanzapine or injuries caused by other medical products, you and your family are entitled to have a well-trained and experienced attorney fighting on your behalf. The attorneys at Heygood, Orr & Pearson have the experience, expertise, and resources to take on any pharmaceutical liability case. Our law firm has pursued claims involving injuries caused by numerous pharmaceutical products.

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If you or a loved one has been injured as a result of prescription drug complications, contact the lawyers at Heygood, Orr & Pearson to learn more about filing a case. For a free legal consultation from an attorney and to find out whether you may qualify to file a lawsuit, please call us toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few simple questions about your case to get started.