Zyprexa, Eli Lilly’s top-selling schizophrenia drug, will now bear stronger warnings that the medication could lead to weight gain, high cholesterol, elevated blood sugar and other metabolic problems. For years, Eli Lilly had refused to acknowledge that the schizophrenia drug carried such risks. But at the same time, the company has spent billions of dollars to settle thousands of lawsuits filed by people who said Zyprexa caused serious injuries.
Eli Lilly announced the new warning labels late last week, with company executives saying that reviews of data from internal tests and outside studies had led to the decision. But many consumer advocates had pressed for the stronger warnings for years, as recent studies indicated that Zyprexa was 50 percent more likely to cause diabetes than older drugs. The Food & Drug Administration had also asked Eli Lilly to include such warnings on Zyprexa’s label.
But until now, Eli Lilly had resisted putting new warnings on Zyprexa’s label. Launched in 1996, Zyprexa is Eli Lilly’s top-selling drug, with sales last year of $4.2 billion. In recent years, tens of thousands of patients have sued Eli 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. In June 2005, Eli Lilly entered into an agreement in principle to settle about 75% of the claims filed against the company by people who said they suffered from diabetes-like symptoms of as a result of Zyprexa. All of the legal and health claim have taken their toll, as prescriptions for Zyprexa have sagged for several years.
Eli Lilly said that the new warnings will be prominently displayed high up in the warning section of the Zyprexa label. The company also sent doctors and other healthcare providers letters advising them of the new warning labels. The label will now warn that Zyprexa is more likely to cause high cholesterol, high blood sugar levels and weight gain than other drugs used to treat the same disorders as Zyprexa. In the case of weight gain, the label will also indicate that patients who take Zyprexa may keep gaining weight for as long as two years after starting therapy. That contradicts Eli Lilly’s previous claims that weight gain on Zyprexa levels off after a few months of use. The Zyprexa label now says that one in six patients will gain more than 33 pounds after two years of use. Weight gain, high cholesterol and high blood sugar are all risk factors for diabetes, but Eli Lilly continues to insist that Zyprexa patients are no more likely to suffer from diabetes than others who take similar drugs.
Most analysts do not expect the new Zyprexa warnings to have much of an effect on sales of the medication. Despite Eli Lilly’s claims to the contrary, the risks associated with Zyprexa have been accepted as fact by the medical community for years. As a result, sales of the drug have been stagnant. However, some legal experts do believe that Eli Lilly’s acknowledgement of Zyprexa’s dangers could lead to even more legal claims against the company.