AstraZeneca has just confirmed that it will be making a $520 million payment to the US government to settle alleged claims concerning inappropriate marketing of <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel (generic: quetiapine), it schizophrenia medication, announced PharmaTimes.
Recently, FiercePharma reported that an adverse event (AE) report for last yearâ€™s third quarter indicated that Seroquel was second in AE reports with 977 cases. The report includes information from an array of sources and the Institute follows adverse event reports for some 2,000 medications, said FiercePharma.
This weekâ€™s agreement was reached with the U.S. Department of Justice (DOJ), other federal agencies, and the National Association of Medicaid Fraud Control Units.
Of the slated amount, $301.9 will be paid to the government, while most of the remainder will be shared with the states; more than $45 million will go to James Wetta, the whistleblower in this case, said PharmaTimes. AstraZeneca made a provision in 2009 for the funds, added PharmaTimes.
The government claimed the drug maker illegally marketed its blockbuster drug from January 2001 to December 2006 for some uses not approved by the US Food and Drug Administration (FDA0, such as aggression, Alzheimerâ€™s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness, said PharmaTimes. Seroquel is approved for the treatment of schizophrenia. And, will it is legal for physicians to prescribe medications off-label, or for purposes for which the medications are not approved, it is illegal for drug companies to market medications for off-label uses.
The government also alleged that the drug maker promoted these unapproved uses â€œby improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programmes,â€ quoted PharmaTimes. The DoJ also claimed AstraZeneca recruited physicians to present themselves as article authors that were, in fact, ghostwritten by medical literature firms, said PharmaTimes, noting that, worse, the doctors involved did not conduct the studies for which they claimed to author.
To compound matters, noted PharmaTimes, the studies and articles were allegedly the bases for promotions for the medicationâ€™s unapproved uses.
While AstraZeneca denies the allegations, its U.S. attorney said that â€œit is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines while avoiding the delay, uncertainty, and expense of protracted litigation,â€ quoted PharmaTimes. The drug maker, in an effort to ensure compliance with laws in the U.S., agreed to a five-year â€œcorporate integrity agreement,â€ added PharmaTimes.
Meanwhile, some antipsychotic medications, including Seroquel, have been linked to a variety of adverse health reactions including weight gain, hyperglycemia, and hyperlipidemia. Science Daily cited a study concerning the metabolic side effects linked to some antipsychotics and how these effects can increase risks for cardiac-related diseases such as diabetes and hypertension. One significant issue with this link is that the severely mentally illâ€”the demographic most prescribed antipsychoticsâ€”have a higher risk of cardiovascular death than the general population, said Science Daily.