Should Eli Lilly Be Worried About This FDA Probe?

Vaccine Syringe NeedleTwo users of Eli Lilly’s (NYSE:LLY) drug Zyprexa were found dead three to four days after taking injections of the longer-lasting antipsychotic.

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High levels of olanzapine were found in the blood of the patients. Olanzapine is the chemical compound found in Zyprexa Relprevv, the longer-lasting spinoff of the original Zyprexa drug. According to the NewsObserver, high levels of olanzapine can lead to cardiac arrest, irregular heartbeat, sedation, or comas.

The Food and Drug Administration posted on its website that it found both patients to have “very high” blood levels of the drug in their systems after their deaths. The agency also noted that both patients received the appropriate dosage of the product.

“Based on the information available to us, we are unable to conclude whether the two deaths were related to administration of Zyprexa Relprevv,” Eli Lilly said in a statement. “However, we are continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product.”

According to the Wall Street Journal, Zyprexa Relprevv was approved by the FDA in December 2009 for the treatment of schizophrenia in adults. An FDA representative said that doctors can continue using the drug, as long as they follow the proper protocol for administering it.

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Zyprexa is Lilly’s all-time best selling drug, with sales topping $5 billion annually at one point, but has since seen a sharp decline after losing U.S. patent protection in 2011. The longer-lasting Zyprexa Relprevv brought in just $60 million in revenue last year, while the company as a whole brought in $22.6 billion.

While it is certainly not in Eli Lilly’s best interest to have an FDA probe on its hands, it doesn’t sound as though this will greatly affect the company. Zyprexa can still be administered, and even if it were to be taken off the shelves, $60 million from $22.6 billion is not a hefty sum.

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