By: Staff Writers | Published: March 9th, 2010
British regulators say that some of AstraZeneca’s claims about the potential weight gain side effects of Seroquel constituted a breach of ethics under that country’s pharmaceutical codes of conduct.
On Monday, the Prescription Medicines Code of Practice Authority concluded that AstraZenca acted in a deceptive manner in at least one Seroquel ad published in the U.K. more than five years ago, which claimed that the drug did not cause as much weight gain as other antipsychotics. The authority says that the statement did not match the known evidence about the risk of weight gain and other Seroquel problems that AstraZeneca had on hand at the time the ad was published.
The UK panel highlighted an advertisement in the British Journal of Psychiatry in 2004, which claimed in large print that Seroquel had a favorable weight profile. The panel concluded that the advertisement was misleading, because the studies AstraZeneca used to support the claim were faulty, which the drug maker should have known. The ad was determined to have violated the requirement that all claims be accurate, fair and able to be substantiated.
The ethics violation ruling comes as the company faces about 26,000 Seroquel lawsuits in the United States, all of which claim that AstraZeneca failed to adequately warn users about the risks of weight gain from Seroquel, which can lead to diabetes and other serious injuries.
The first Seroquel trial is currently underway in New Jersey state court.
What AstraZeneca knew about the weight gain effects of Seroquel is expected to take center stage in this case, as well as other lawsuits pending in state and federal courts throughout the U.S. Internal documents produced during the Seroquel litigation suggest that the drug maker was aware of the potential weight-gain Seroquel side effects and continued to promote the drug as weight-neutral for years after clinical evidence demonstrated significant problems that could lead to diabetes and other injuries.
The drug maker has racked up $656 million in legal defense costs fighting the failure-to-warn lawsuits over Seroquel. In addition, Seroquel lawyers continue to file new cases for individuals who have developed diabetes, pancreatitis and a rare movement disorder known as tardive dyskinesia, so the cost of the litigation is expected to continue to increase.