UK, Japan. Clinical and blood glucose monitoring is recommended in diabetic patients receiving olanzapine, used in the treatment of schizophrenia, says the UK Medicines Control Agency (MCA). Reports of hyperglycaemia and diabetes mellitus associated with the use of olanzapine (Zyprexa) have been received by the agency, prompting appropriate changes to the product information. The MCA has received 40 reports of hyperglycaemia, diabetes mellitus, or exacerbation of diabetes, in association with olanzapine; 4 of the reports involved ketoacidosis and/or coma, including 1 case with a fatal outcome. While the mechanism of this suspected adverse reaction is still under investigation, rapid bodyweight gain following the initiation of olanzapine therapy may precede the development of hyper-glycaemia or exacerbation of pre-existing diabetes. The product information now recommends appropriate clinical and blood glucose monitoring for diabetic patients, and for patients with risk factors for diabetes, who are treated with olanzapine.

The Pharmaceutical & Food Safety Bureau (PFSB) of the Ministry of Health, Labour & Welfare (MHLW), Japan has ordered the revision of the package insert for olanzapine (Zyprexa), a psychotropic drug used in the treatment of schizophrenia. The new package insert will warn about the risk of serious hyperglycaemia with olanzapine and reflect the following information:

Patients with diabetes or with a history of diabetes are additionally contraindicated to the use of olanzapine; special care is required in patients with risk factors for diabetes, such as family history of diabetes, hyperglycemia, obesity etc; careful follow-up procedures including glycaemia check should be in-place during olanzapine administration. Medical professionals should brief patients and family members about the risks and signs and symptoms of hyperglycaemia.

The MHLW issued the above order following several reports of hyperglycaemia (nine with two deaths) in which causality with the use of olanzapine could not be ruled out.

The PFSB has also instructed Eli Lilly Japan K.K., the manufacturer of olanzapine (Zyprexa) to distribute a dear-doctor letter for the above information.

Reports in WHO-file: Diabetes mellitus 163, diabetes mellitus aggravated 24, hyperglycaemia 295

Reference:

1. Olanzapine (Zyprexa) and diabetes. Current Problems in Pharmacovigilance 28: 3, Apr 2002.

2. Press Release, Safety Div./MHLW, 16 Apr 2002.

3. Pharma Japan 1793, p. 16, 29 Apr and 6 May 2002.