War of words over atypicals link to diabetes
pharmafile | February 5, 2004 | News story | |
Pfizer and Eli Lilly have tried to distance their products from renewed claims that atypical antipsychotics are linked to an increased risk of diabetes.
The companies are trying to limit the impact of a warning of a consensus paper published in peer-reviewed Diabetes Care that patients taking newer atypical antipsychotic drugs could face an increased risk of obesity, diabetes and high cholesterol.
It particularly noted that Novartis' Clozaril and Lilly's Zyprexa, although still effective treatment options, posed a greater risk to patients of weight gain, diabetes and lipid disorders than others.
The paper, which was put together by the ADA, the American Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity, called on doctors to carefully screen and monitor patients taking antipsychotics for signs of rapid weight gain or other problems that could lead to diabetes, obesity and heart disease and refer them to specialists if necessary.
The associations concluded there was "considerable evidence" that treatment with second-generation atypicals could lead to rapid weight gain and that most of that weight gained is fat. Studies also show an association between the use of this class of drugs and the development of pre-diabetes, diabetes, and elevated blood lipid levels.
Eli Lilly, manufacturer of market leader Zyprexa has hit back at the claims, saying they are not supported by the body of evidence available on the subject, and are in direct conflict with the FDA's recent class labelling changes.
The company said it was oncerned that the inconsistency between FDA labelling and this consensus opinion conclusion may confuse patients and prescribers.
In September an FDA advisory committee recommended all the newer medicines in the class should have new labelling warning of an increased risk of diabetes, a measure which would effectively put all the products on a level playing field with regard to the side-effects.
But Pfizer has maintained there is no evidence to links its product Geodon to weight gain and is requesting new labelling which will distance it from the risk – a difference which could provide a vital marketing tool for a product lagging behind its competitors.
Vice president of US Medical, Psychiatry and Neurology at Pfizer Cathryn Clary said: "We believe these requested label changes, based on the clinical trial database, as well as three years of post-marketing clinical experience worldwide, reflect the best information available on use of Geodon in schizophrenia."
The company wants Geodon's labelling to include its lack of adverse effects on blood lipids and glycaemic control; greater initial dosing flexibility; and modification of language regarding the drug's effect on heart rhythm.
The ADA consensus paper drew on a number of studies including one published last year involving 20,000 US schizophrenia patients which showed a link between all the drugs in the class and diabetes.
The incidence of diabetes in Zyprexa patients was 27% more than those on older 'typical' anti-psychotics, while Johnson & Johnson's Risperdal showed a 49% increased incidence. But patients on AstraZeneca's Seroquel were shown to be at far higher risk, being over three times as likely to develop diabetes than those on atypicals.
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