USA. The United States Food and Drug Administration (US FDA) has requested that Bristol-Myers Squibb Company, the manufacturer of the atypical antipsychotic drug aripiprazole (Abilify) should update the prescribing information for the drug to reflect the risk of hyperglycaemia and diabetes in patients treated with this drug. More recently, Novartis, under advice from the US FDA has also made similar changes to the prescribing information for clozapine (Clozaril) antipsychotic tablets. The US FDA has recommended these revisions after reviewing data related to the use of atypical antipsychotics and hyper-glycaemia with its related symptoms (e.g., polydipsia, polyuria, polyphagia and weakness). The FDA has concluded that all atypical antipsychotics should be updated to include information about the potential for these adverse events. Patients with risk factors for diabetes should undergo baseline screening before treatment with any atypical antipsychotic drug and routine monitoring should be undertaken throughout therapy to mitigate the risk of patients developing serious metabolic complications. In January 2004 AstraZeneca Pharmaceuticals LP, manufacturer of atypical antipsychotic agent quetiapine fumarate (Seroquel), had warned health professionals that patients should be monitored for glucose control before starting treatment with atypical antipsychotics. More recently, in April 2004, the company has issued an additional letter that besides pre-treatment monitoring, patients should also be monitored periodically for worsening of glucose control throughout treatment.
1. 'Dear Healthcare Practitioner' letter from Bristol-Myers Squibb Company, 25 March 2004. Available from URL: www.fda.gov/medwatch
2. 'Dear Healthcare Provider' letter from Novartis, 01 April 2004. Available from URL: http://www.fda.gov/medwatch
3. 'Dear Healthcare Provider' letter from AstraZeneca Pharmaceuticals LP, 22 April 2004. Available from URL: http://www.fda.gov/medwatch