Adverse reactions to rosiglitazone (Avandia®, Avandamet®, Avaglim®)

- Update on announcement of 23 May 2007

As part of its regular monitoring of adverse reactions, the EU agencies are now investigating two types of adverse reactions, in particular: 1) risk of heart-related adverse reactions 2) risk of bone-related adverse reactions.

The medicinal product rosiglitazone is used for treatment of type 2 diabetes as monotherapy or in combination with other medicinal products in tablet form (metformin, sulfonylurea).

Increased risk of heart-related adverse reactions

Research points to a possible increased risk of

• myocardial infarction
• increased impairment of the cardiac function
• death as a result of heart failure.

This knowledge primarily stems from an article posted in the New England Journal of Medicine published in May this year, see announcement of 23 May 2007 in the factbox to the right.

It has not been scientifically documented that there is an increased risk in heart patients. Nevertheless, the suspected risk cannot be ruled out. A number of scientific studies have been initiated with a view to further examining the risk of heart-related adverse reactions.

For this reason, it already appears from the summary of product characteristics that rosiglitazone must not be used in patients with impaired cardiac function. Furthermore, the summary of product characteristics also recommends cautious use of rosiglitazone in patients with fluid retention since this condition could contribute to cardiac failure, see the summary of product characteristics in the factbox to the right (in Danish only).

Increased risk of bone-related adverse reactions

Studies indicate that long-term treatment with rosiglitazone could increase the risk of osteoporosis and fractures in women. It cannot be ruled out that men are also at an increased risk. A number of studies have been initiated to elucidate the effect of rosiglitazone on the bones.

The safety is assessed on an ongoing basis

In cooperation with the other EU agencies, the Danish Medicines Agency assesses the safety of taking rosiglitazone as new knowledge emerges.

The next time will be at EU meetings in October 2007. At that time, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Working Party will report further on the subject.

Recommendations by the Danish Medicines Agency

The Danish Medicines Agency reminds doctors to follow the recommendations of the summary of product characteristics. The Agency also encourages doctors to take account of the suspected increased risk of bone-related adverse reactions.

The Danish Medicines Agency advises patients not to stop treatment with rosiglitazone and to contact their doctor if they are unsure about the treatment.

The Danish Medicines Agency requests doctors and patients to report any observed adverse reactions.

For further information, please contact Chief Medical Officer Doris I. Stenver, telephone +45 4488 9247.

The Danish Medicines Agency, 15 August 2007