Health trends

Avandia use suspended

GlaxoSmithKline (GSK) confirms that following a review of Avandia (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has announced their individual regulatory decisions and the resulting actions.

In the European Union, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim). As a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options. The EMA has stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.

In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) will remain available with additional safety labelling and restrictions for use. The FDA will also require a Risk Evaluation and Mitigation Strategy (REMS) programme with additional measures to ensure the safe use of the medicine.

Dr Ellen Strahlman, GSK's Chief Medical Officer, said: "Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients."

- Source: GlaxoSmithKline

New drug for gout approved

The US Food and Drug Administration recently approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy. Gout occurs due to an excess of the bodily waste uric acid, which is eventually deposited as needle-like crystals in the joints or in soft tissue. These crystals can cause intermittent swelling, redness, heat, pain and stiffness in the joints.

Gout is strongly associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease.

"About three per cent of the three million adults who suffer from gout are not helped by conventional therapy. This new drug offers an important new option for them," said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

- Source: The U.S. Food and Drug Administration