Information on the medicinal product Avandia (roziglitazone)
22.02.2010
Warnings about the complications linked to cardiovascular diseases in patients taking the medicinal product Avandia (roziglitazone), which are currently a subject of debate in the USA, were issued by the Agency for Medicinal Products and Medical Devices back in 2007 and 2008, and consequently, in 2008, safety labeling revisions were made to the Summary of Product Characteristics (intended for healthcare professionals) and the Patient Information Leaflet (intended for patients). The Agency's notices from 2007 and 2008 are available at our website (www.halmed.hr/en/), under the following links:
- Press release on cardiac safety of the use of roziglitazone (News of 29.05.2007.)
- New warnings and contraindications for roziglitazone (Avandia) - press release by the European Medicines Agency (News of 25.01.2008.)
Based on the above mentioned, it may be concluded that the adverse reactions that have caught public's attention, relating to the medicinal product Avandia, had been known beforehand and that the European Medicines Agency, and the Croatian Agency for Medicinal Products and Medical Devices, estimated that the benefit from the use of the medicinal product by patients suffering from type II diabetes outweighed the possible risk. However, this medicinal product should not be used by the patients who are suffering from or have suffered from heart failure, or other cardiovascular diseases.
In the Republic of Croatia, Avandia is used by around 4500 type II diabetes patients, and cannot be obtained without a prescription.
Since 2005, a total of 4 reports of 4 adverse reactions to Avandia have been made in the Republic of Croatia: three reports involved increased loss of hair, which stopped after the treatment was suspended, and in one case, milder edema of the patient's bruised shins were reported.
The Agency for Medicinal Products and Medical Devices of the Republic of Croatia continuously monitors safety information for all medicinal products marketed in Croatia and, in case of any new information regarding the medicinal product Avandia, will promptly inform the public accordingly.
Croatian patients also have an access to the medicinal product Avandamet (roziglitazone and metformin), which is also used in treatment of type II diabetes patients. Contraindications, adverse reactions, special warnings and precautionary measures concerning Avandia also apply to Avandamet.
