FDA concerned about sedation caused by Eli Lilly & Co's Zyprexa

Is Zyprexa safe for a schizophrenic? FDA tries to give answers.

Zyprexa, originally Olanzapine, is an atypical antipsychotic, approved by FDA for the treatment of schizophrenia on 1996. Its formulations are manufactured and marketed by the pharmaceutical company Eli Lilly and Company, whose patent for olanzapine proper expires in 2011.

Zyprexa is available as a tablet in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg and orally disintegrating wafers (known as Zydis), which dissolve on the tongue, in strengths of 5 mg, 10 mg, 15 mg and 20 mg. It is also available as a rapid-acting intramuscular injection for short-term acute use.

Dose may be adjusted depending on the person's response to the drug. The dose also will depend on certain medical problems the person may have. It is generally recommended to be taken once daily before bed as it is highly sedating.

But a monthly injection instead of daily tablets may cause profound sedation, said FDA while examining the effects of the drug. The sleepiness is a serious problem because of its severity and relatively high incidence.

Highly concerned by this problem FDA advisory panel will meet Feb. 6 to consider the fate of injected Zyprexa. Though the sales of tablets experienced 9 percent rise to $4.76 billion last year, the drugmaker is investing money in something new and modernized confined by tight terms – Zyprexa in tablets will exist till 2011.

According to FDA sleepiness occurred in 1.3 percent of patients, but it doesn’t exclude the external factors. For example, the sleepiness may be caused by doctors accidentally injecting the medicine into a blood vessel rather than into muscle, or due to rapid release of the drug.

These suppositions spurred Eli Lilly and Company to conduct a thorough study of 5,000 people to observe side effects after the drug goes on sale.

Sleepiness is not the only side effect of this drug. It can cause tardive dyskinesia and rare, but life-threatening, neuroleptic malignant syndrome. Other recognised side effects may include: dry mouth, dizziness, insomnia, weight gain (90% of users experience weight gain), increased appetite, runny nose, low blood pressure, impaired judgment, thinking, and motor skills, trouble swallowing, dental problems and discoloration of teeth, problems with keeping body temperature regulated, apathy, lack of emotion and others.

According to a New York Times article published on December 17, 2006 , Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.

The documents, given to The New York Times by Jim Gottstein, a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes. The Times of London also obtained copies of the documents and reported that as early as October 1998, Lilly considered the risk of drug-induced obesity to be a "top threat" to Zyprexa sales. In another document, dated October 9, 2000, senior Lilly research physician Robert Baker noted that an academic advisory board he belonged to was "quite impressed by the magnitude of weight gain on olanzapine and implications for glucose."

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, another study showed 16% of Zyprexa patients gained at least 30kg (66 pounds) in one year, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004. In 2006, Lilly paid $700 million to settle 8,000 lawsuits from people who said they had developed diabetes or other diseases after taking Zyprexa. Thousands more suits are still pending.

In 2002, British and Japanese regulatory agencies warned that Zyprexa may be linked to diabetes, but even after the FDA issued a similar warning in 2003, Lilly did not publicly disclose their own findings.

Eli Lilly agreed on January 4, 2007 to pay up to $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa. Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.

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