FDA warns of potentially fatal skin reactions to Lilly's Zyprexa


The FDA is warning about potentially fatal skin reactions tied to Eli Lilly’s ($LLY) antipsychotic Zyprexa (olanzapine). The news deals some unfavorable cards to Lilly as it competes in a crowded long-acting injectables market.

Regulators are adding a warning to the label of all products containing olanzapine. The warning says the drugs can cause Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a rare but serious skin condition that can spread to other parts of the body. The warning includes branded Zyprexa, Zyprexa Zydis and Zyprexa Relprevv, as well as olanzapine generics, the FDA said in a safety communication.

The agency decided to issue the warning after uncovering 23 cases of DRESS reported with Zyprexa since the drug was approved in 1996. But the FDA’s Adverse Event Reporting Database (FAERS) only includes reports voluntarily submitted to the agency, so “there are likely to be additional cases about which FDA is unaware,” regulators said.

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One individual on Zyprexa experienced DRESS and died. The patient was taking multiple medications, though, so interactions could also have contributed to the death, the FDA said.

DRESS starts as a rash that spreads and includes symptoms such as fever, swollen lymph nodes and a swollen face. It can trigger organ injury and in some cases, death. The mortality rate is up to 10%, the FDA said.

Regulators are recommending that patients taking a Zyprexa product who experience DRESS symptoms seek medical attention right away. The agency is also encouraging medical professionals and patients to report any side effects through its adverse event reporting system.

This is not the first time Lilly has dealt with safety issues for its Zyprexa franchise. Zyprexa Relprevv’s label warns about an increased risk of “post-injection delirium sedation syndrome,” which happens when the drug enters the blood too quickly. A once-daily version of Zyprexa was scrutinized after reports of weight gain and diabetes linked to the med surfaced.

The latest safety issue doesn’t make things any easier for Lilly as it competes for dominance in the schizophrenia market, which is expected to grow to $6.4 billion in 2017. Lilly is counting on its injectable Zyprexa Relprevv to do some of the work, now that its blockbuster Zyprexa pill has gone generic.

But Zyprexa Relprevv has struggled to live up to its predecessor. It brought in $1 billion last year, a 13% drop from 2013. The drug’s key patent doesn’t expire until 2018, though, which leaves some room for growth.

Meanwhile, other drugmakers are also making progress with long-acting injectable antipsychotics. Lundbeck and Otsuka have a once-a-month version of Abilify called Abilify Maintena. Analysts set peak sales for that drug between $500 million and $1 billion.

Johnson & Johnson’s ($JNJ) once-monthly antipsychotic, Invega Sustenna, is already bringing in blockbuster sales for the company. A new, longer-acting formula--if and when it is approved--could give J&J’s franchise an even bigger boost.

- read the FDA safety alert

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FDA probes long-acting Zyprexa safety after 2 patients die
FDA nixes long-acting Zyprexa
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