FDA issues warning about rare, but serious, side effect in Lilly antipsychotic drug

pharmafile | May 12, 2016 | News story | Medical Communications, Sales and Marketing Eli Lilly, FDA, anti-psychotic, boxed warning, lilly, olanzapine, skin condition 

The US Food and Drug Administration (FDA) has issued a new warning to all drug labels for Eli Lilly’s antipsychotic drug, olanzapine. The drug can cause a rare but serious skin reaction, called DRESS (Drug reaction with eosinophilia and systemic symptoms), which can progress to affect other parts of the body.

Since the drugs approval in 1996, there have been 23 cases brought to the FDA where patients taking olanzapine suffering symptoms of DRESS. The FDA, however, estimates there may be many more cases which were never reported to them. In one of the 23 cases reported to the FDA, the patient taking olanzapine died, although the drug itself was not isolated as a sole cause as the patient was taking multiple medicines that could have contributed.

DRESS may begin as a rash that can quickly spread to all parts of the body. It can include fever and swollen lymph nodes and a swollen face. It can result in damage to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. It has a mortality rate of up to 10%.

The FDA recommends against immediately discontinuing use of the drug if potential symptoms appear, as the drug has proven effective in the treatment of schizophrenia and bipolar disorder, until the patient consults their physician.

Despite generics coming to market, olanzapine remains a big earner for Lilly. Marketed as Zyprexa and Symbyax, it still earns approximately $940 million each year.

The drug may have earned Lilly billions in revenue, but it also proved very costly. In 2009, the company pleaded guilty to illegally marketing Zyprexa for off-label use and paid a fine of $1.4 billion.

Sean Murray

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