Eli Lilly to bolster Zyprexa warning
Source: Indianapolis Star
Drug’s label will emphasize blood sugar, weight risks
After batting down criticism for years that it underplayed the risks of its blockbuster antipsychotic drug Zyprexa, Eli Lilly and Co. is beefing up the drug’s label to add stronger language concerning weight gain and elevated blood sugar.
Some critics chided the Indianapolis drug maker for waiting so long to take such steps. One analyst said the move might encourage more legal claims against the company.
Lilly said Friday it is taking the steps after reviewing more data from internal tests and major outside studies. The company said it will display the information prominently in the warning section of the label, rather than lower, where it might be missed.
“Now it will be closer to the front of the label and provide a more prominent information point for physicians,” said Lilly spokeswoman Marni Lemons.
Lilly also acknowledged, in a letter to doctors, that Zyprexa is more likely to raise blood-sugar levels than competing drugs.
Zyprexa, launched in 1996, is Lilly’s top-selling drug, with sales last year of $4.2 billion. But the company has been battling legal and health claims, while trying to reassure doctors that the drug is safe to prescribe. Prescriptions sagged for several years.
In recent years, tens of thousands of patients have sued Lilly, claiming the company hid or downplayed the risks of Zyprexa. They said the drug gave them diabetes symptoms, including weight gain and higher blood sugar. Lilly has steadfastly denied that, but has paid more than $1 billion to settle thousands of claims.
Les Funtleyder, a drug analyst at Miller Tabak & Co. in New York, said the move is not a major shift for Lilly, “but is a bit of acknowledgement of reality that it needs to do more to address this.”
“If they change the label, it could actually encourage more claims,” he added. “But legal issues are very difficult to handicap.”
MindFreedom International, an Oregon-based coalition of mental health groups, criticized Lilly’s move as “too little, too late for patients who have been hurt.”
“Lilly has known the risks of Zyprexa for years, so why did it take them so long?” said David Oaks, the group’s director.
But Lilly said it is beefing up the warnings based on additional data and analysis, including information from two external studies that examined the class of drugs, known as atypical antipsychotics.
Meanwhile, more states are suing Lilly, claiming it marketed Zyprexa for off-label uses, including for treatment of dementia, depression and autism, without warning about its risks. And the Food and Drug Administration is considering approving Zyprexa for adolescents with schizophrenia and bipolar disease.
The company also will include new warnings for Symbyax, a drug that treats bipolar depression by using a combination of active ingredients in Zyprexa, an antipsychotic, and Prozac, an antidepressant.
Shares of Lilly closed Friday at $59.47, up 51 cents.