A risky drug may get wider marketThe FDA may approve Zyprexa for kids, despite its significant side effects in adult use. By ROBERT FARLEY, Times Staff WriterPublished December 16, 2007It sounds like a cosmic, FDA joke: The Food and Drug Administration approves the antipsychotic drug Zyprexa to treat adults with schizophrenia or bipolar disorder. It becomes a market wonder, a bestseller. But the side effects turn out to be dangerous; some patients develop diabetes. Some 30,000 people sue the manufacturer, Eli Lilly. The pharmaceutical giant shells out more than $1-billion to settle the cases. Here comes the punch line: Though studies show that kids are even more susceptible to Zyprexa's dangerous side effects, now Lilly wants the government's seal of approval for adolescents to use it. And the FDA is about to say yes. * * * Like a mounted animal head hung as a trophy from the hunt, a framed copy of a $2.8-million check from Bayer pharmaceutical hangs in the law office of Joseph Saunders. The check says: It's my business to sue drug companies, and I'm good at it. Saunders practices in Pinellas Park, but hundreds of lawyers like him across the country have found a niche suing Lilly. He has eight Zyprexa clients. Most are psychotic. Most suffer from diabetes, which can cause kidney failure, heart disease, liver damage, blindness. They were prescribed Zyprexa during the time doctors swooned over the big new thing. Approved by the FDA in 1996, Zyprexa was one of a new class of drugs called atypicals, marketed as powerfully effective for people suffering the dreadful psychotic breaks of schizophrenia and bipolar disorder. And -- this was key -- the new drugs were less likely to cause the tremors and facial tics that sometimes accompanied older drugs. Zyprexa was deemed so safe, doctors began prescribing it "off-label" to treat depression, anxiety, ADHD, even sleeplessness. As it turned out, studies would show that Zyprexa may be the most effective of the new class of antipsychotic drugs, but it's also most likely to cause serious weight gain and elevated blood sugar levels. Saunders says you can't win a lawsuit against a drug company just because you suffer a side effect. But pharmaceuticals do have a legal responsibility to warn doctors about known risks. The tens of thousands of lawsuits contend that Lilly did not fully disclose risks it discovered during studies conducted to get FDA approval for Zyprexa, risks that became more apparent in the years after the drug hit the market.

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