Seroquel XR Approved in Europe as Add-On Treatment for Depression

European Union drug regulators have approved an extended release version of AstraZeneca’s antipsychotic medication, Seroquel, for use by some patients suffering from depression.

The approval of Seroquel XR was announced last week by the European Medicines Agency, which overturned an earlier rejection of the drug by The Netherlands. The EU approval follows a similar green light for the drug by FDA in the U.S. in December. The approvals come despite concerns over the risk of problems from Seroquel, which some believe may outweigh the benefits of using the drug to treat depression

The new version, Seroquel XR, is an extended release formula which European regulators have agreed to allow as an add-on treatment for depression. The Dutch originally reviewed, and rejected, the drug while acting as a reference state for the rest of the EU under mutual recognition procedures in May 2009. AstraZeneca protested the decision and sent a new application to the European Medicines Agency, which reviews drugs for use across the EU.  

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. More than 19 million people worldwide have used the medication for both approved and non-approved uses. However, side effects of Seroquel have been linked to an increased risk of weight gain, hyperglycemia and diabetes.

Last month, the UK charged AstraZeneca with ethics violation charges, saying that the company made misleading statements about Seroquel weight gain side effects.

AstraZeneca currently faces thousands of Seroquel lawsuits in the United States that allege the company failed to adequately warn about the risk of weight gain and other metabolic side effects, which allegedly caused users to develop diabetes and other Seroquel health problems.