The marketing team sued over a drug’s alleged side effects tried to suppress key data, an ex-employee has claimed. Seroquel’s former UK medical adviser told the BBC he was pressured to approve promotional material which said weight gain was not an issue. Maker AstraZeneca, which faces fresh legal action next month, said it took concerns about its conduct seriously.
Drugmakers encouraged doctors to prescribe these drugs for children before the FDA sanctioned their use for youngsters. This was particularly troubling, given that the drugs can cause diabetes and weight gain, side effects that prompted thousands of lawsuits claiming that drugmakers tried to hide evidence of these problems.
A study published last month in the Journal of the American Medical Association found the drugs caused children and adolescents to gain an average of 19 pounds in 11 weeks of treatment. The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease. A top Food and Drug Administration official said Tuesday the agency is considering strengthening the labels of antipsychotic drugs to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults.
FDA drug reviewers said medical researchers have found a direct link between the use of so-called atypical antipsychotics (Seroquel, Zyprexa, Abilify, Risperdal) in younger children and weight gain, high cholesterol, and increased blood pressure.
AstraZeneca paid Chicago psychiatrist Dr. Michael Reinstein $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of residents in Chicago-area nursing homes.