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Warning added for Abilify

The Food and Drug Administration (FDA) requested on March 25, 2004 that Bristol-Myers Squibb and a warning to the prescribing information of AbilifyTM (aripiprazole) regarding the risk of hyperglycemia and diabetes. The FDA had previously asked that all atypical antipsychotics include a warning regarding the risk of hyperglycemia and diabetes. The general warning states that hyperglycemia, in some cases extreme, has been reported in patients treated with atypical antipsychotics. Specifically for Abilify® , the case reports have been few and limited to inpatients. Since Abilify® is rather new to the market, it is unknown if the true incidence is known. There are epidemiological studies that suggest an increase risk hyperglycemia relating to the use of antipsychotics. These studies did not include Abilify® .

Abilify® is an atypical antipsychotic approved for the treatment of schizophrenia. While there has not yet been an association determined between the use of Abilify® and the development of diabetes, further studies are needed to make a solid determination. It would be good clinical practice to monitor patients, whether currently taking or newly starting treatment with Abilify® , for signs or symptoms of hyperglycemia. Symptoms of hyperglycemia may include polydipsia, polyuria, polyphagia, or weakness. Patients with risk factors for diabetes such as obesity or a family history of diabetes should be undergo a fasting blood glucose test prior to initiating therapy with Abilify® and regularly throughout therapy. While there have been reports of hyperglycemia resolving following the discontinuation of therapy from Abilify® , some patients may require treatment for diabetes after Abilify® therapy is discontinued.

References:

1). www.fda.gov

2). PDR, 58 edition, 2004, pages1034-8

Andy Shay, PharmD. Candidate