US drug giant Eli Lilly has agreed to pay the state of Alaska $15 million to settle claims that its Medicaid programme was not adequately warned over potential side effects from the use of its antipsychotic Zyprexa.

Zyprexa (olanzapine) first hit the US market in 1996 and is approved for the short- and long-term treatment of schizophrenia, acute mixed or manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder. Since its introduction, the drug has been prescribed to around 23 million across the globe, and pulled in sales of $1.27 billion in the fourth quarter of last year.

However, the class of atypical antipsychotics - and in particular Zyprexa it seems - are associated with hyperglycaemia and other side effects such as altered lipid levels and weight gain, and the lawsuit alleged that the state of Alaska and its healthcare providers were “insufficiently warned about possible side effects relating to weight gain, high blood sugar and diabetes, causing harm to the state's Medicaid recipients and increased costs to the state”.

The lawsuit asked that Lilly pay the state for those costs as well as civil penalties under the Alaska Unfair Trade Practices and Consumer Protection Act. But, while the company has agreed to hand out $15 million to settle the claims, it stressed that the agreement “involves no admission of wrongdoing”.

“We believe this settlement is in the best interest of the company, the state, and, importantly, of the patients, families and healthcare professionals for whom Zyprexa is an important treatment option,” commented Robert Armitage, Lilly's senior vice president and general counsel, adding: “Our decision to resolve this case does not change the fact that Zyprexa can continue to improve the lives of patients around the world who are suffering from schizophrenia and bipolar disorder”.

More challenges
Lilly is, however, still facing a stream of legal challenges by other US states over Zyprexa, the most recent being a lawsuit by Conneticut claiming that the firm marketed its antipsychotic for unapproved off-label uses and hid side effects such as weight gain and diabetes.

Announcing the lawsuit earlier this month, the state’s Attorney General Richard Blumenthal claimed that the company “allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centres as part of a massive illegal marketing campaign” to promote Zyprexa, notably among children, for anxiety, depression and attention-deficit hyperactivity disorder, and that it also “dangerously concealed” risks associated with the drug’s use.

Eight other US states have filed suit over Zyprexa and Lilly is currently in talks with the Attorney General in Philadelphia and several states regarding a possible settlement, although the drugmaker insists that the claims are without merit.