Atypical anti-psychotics to get diabetes warning in US
pharmafile | October 28, 2003 | News story | |Â Â Â
All atypical anti-psychotic drugs are to carry warnings on their US labels about potentially fatal hyperglycaemia side-effects and increased risk of developing diabetes.
The FDA made its announcement when reviewing a new formulation of Eli Lilly market-leading atypical Zyprexa.
The Agency said that although the link between the class of drugs and type 2 diabetes was not yet fully understood, label warnings would help alert patients to the dangers.
"Increased attention to the signs and symptoms of diabetes mellitus may lead to earlier detection and appropriate treatment, and thus reduce the risk for the most serious outcomes," the FDA stated in a letter to the company.
A recently published US study involving 20,000 schizophrenia patients showed a link between all the drugs in the class and diabetes.
The incidence of diabetes in Zyprexa patients was 27% than those on older 'typical' anti-psychotics, while Johnson & Johnson's Risperdal showed a 49% increased incidence. But patients on AstraZeneca Seroquel were shown to be at far higher risk, being over three times as likely to develop diabetes than those on atypicals.
Despite these trial results, the FDA new label warning states that the data is unable to prove differences between the products in hyperglycaemia-related adverse reactions.
Clozaril, marketed by Novartis, Pfizer Geodon (ziprasidone) and Bristol-Myers Squibb newly launched Abilify will also carry the warning.
Because the label change applies across the board to all the competitors, analysts predict the news will not greatly affect US prescribing.
"The new label warning will have very limited impact on sales of any atypical drugs because doctors are already familiar with their link to diabetes," Sena Lund, analyst with Cathay Financial LLC told Reuters.
Establishing a link between the drugs and type 2 diabetes is confounded by the fact that schizophrenics are at a higher risk of developing the condition, as well its increasing incidence in the population as a whole.
Nevertheless one of the chief selling points of BMSAbilify is that – unlike Zyprexa – it does not cause weight gain among schizophrenics, although like its competitors, has a long list of other side-effects.
Abilify, which BMS developed and market with Otsuka, is estimated to achieve sales of up to $500 million this year, and is expected to reach blockbuster status within a few years.
Launched in 1996, Zyprexa continues to lead the pack, with 2002 sales of $3.69 billion, with Risperdal in second with $2.3 billion and Seroquel in third with $1.1 billion.
The FDA says all atypical antipsychotic patients should have their blood glucose monitored, whether they are already have type 2 diabetes, have risk factors or are symptomless.
