The Royal New Zealand College of General Practitioners

In December 2010 the Medicines Adverse Reactions Committee (MARC) and Medsafe conducted a statutory review of the benefits and risks of treatment with rosiglitazone-containing medicines. This followed regulatory action in Europe suspending rosiglitazone-containing medicines and to impose significant restrictions on use in the U.S.

The potential of rosiglitazone to cause myocardial infarction was of primary concern in the MARC review. The MARC considered that data from meta-analyses and observational studies were consistent with an increased risk of myocardial infarction in patients treated with rosiglitazone. The same risk was not seen for pioglitazone. Conversely, a randomised (but open-label) clinical study investigating cardiovascular safety of rosiglitazone (RECORD study) did not show any such association. Overall the MARC considered that the balance of benefits and risks for rosiglitazone was unfavourable.

In view of the conflicting data, the MARC recommended that the most appropriate action was suspension of the consents to distribute rosiglitazone containing medicines in New Zealand, until such time as satisfactory evidence can be provided by the company to identify a population of patients for whom the benefits of rosiglitazone treatment outweigh the risks.

To allow a period of time for patients to initiate alternative treatment the MARC recommended a delay to the suspension coming into effect. Thus the date for suspension of Avandia is 29 April 2011. After this date Avandia can only be legally supplied in New Zealand under the provisions in the Medicines Act 1981 that relate to the supply of unapproved medicines.

Medsafe advises that although pioglitazone may be the most obvious alternative treatment, this may not be appropriate for patients who are at high risk of heart failure or fracture. When selecting alternative treatments consideration should be given to recommended combinations, contraindications, cautions and side effects (as outlined in the data sheets) as well as patient preference. If pioglitazone is the alternative treatment of choice, please note that 30 mg of pioglitazone is roughly equivalent to 4 mg of rosiglitazone in terms of HbA1c reduction.

Yours sincerely

Stewart Jessamine                                   
Group Manager Acting Chair                      

David Reith
Medsafe Medicines Adverse Reactions Committee