Side effects of Seroquel covered by Astra Zeneca
Seattle – Astra Zeneca’s block buster drug, Seroquel is the second biggest selling drug for the company. Sales reports of 2008 reveal that Seroquel has fetched $4.5 bn alone. Seroquel belongs to the class of atypical anti-psychotics and is used in the treatment of Schizophrenia and Bipolar disorders. Attorneys from plaintiffs’ have filed lawsuit against Astra Zeneca for not revealing complete information to physicians and patients. According to lawsuit, possible side effects include diabetes, weight gain and related problems which may include kidney failure, heart attack and damage to pancreas.
Group of lawyers educated to U.S. federal court in a sealed envelope that company was aware about these side effects since 2000 but did not reveal to the doctors and patients. It was also informed to federal court that company promoted the drug as if there were no side effects associated and the drug was absolutely safe for the use. Lawyers informed that they have copies of e-mail correspondences and other documents from Astra Zeneca officials which have the link for weight gain and other possible side effects. This leads towards the case of hiding potential information and misleading people.
Among dozens of sealed envelopes and other hundreds of pages submitted to the court, “Safety Position Paper” from global drug safety physician, Dr. Wayne K. Geller revealed that 27 cases were reported from 1994 to 2000 which indicated 19 new cases of diabetes and 8 had exacerbation of existing diabetes. Other email copy from company’s publication manager mentioned that company had “buried” three clinical trials and was considering doing fourth by name COSTAR. It is also believed that Seroquel is being marketed for off-label and unapproved treatment for the ailments like depression, dementia, insomnia and attention deficit disorder.
Company spokes person and official, Tony Jewell has countered the statement by defending that Astra Zeneca had studied the molecule Seroquel extensively and have submitted enough clinical data to Food and Drug Administration (FDA). Depending on the submitted data, FDA had approved the drug as safe medication in 1997. According to company officials, drug label of Seroquel provides all the information about the risk and side effects of the drug which was available with them. FDA has already asked and would like to extensively review additional information from Astra Zeneca on Seroquel XR drug, it is an extended release formulation submitted to FDA for approval for the indication of anxiety and depression.
First two cases about causing the harm are been rejected by court. Total 9,000 lawsuits involving 15,000 patients have been filed against the drug and the company under one judge in Orlando, Fla. Some of the cases have also been filed in the state courts of New Jersey, New York and Delaware.