Tag Archives: FDA

Pharma Funded FDA’s Christmas Present to Drug Companies: Approving use of deadly antipsychotic drugs for kids

Many states have sued over the cost of atypical antipsychotic drugs, especially the cost of treating the diabetes and metabolic disorders they cause, which has decimated Medicaid budgets. Yet now the FDA gives pharma the Christmas present of approving Seroquel and Zyprexa for children and hence, Medicaid reimbursement even as its own Division of Pharmacovigilance (DPV) reported a “a direct association between adverse metabolic effects of treatment with atypical antipsychotics” and children!

Cooking the Books:The statistical games behind “off-label” prescription drug use

Study patients took the anti-seizure drug Neurontin, and researchers measured tons of possible outcomes (like pain with touch, pain with cold, excessive pain with pinpricks, more than a dozen different scales for psychiatric symptoms, and so on). By random chance, if you measure enough outcomes, at least some of them will appear better after drug treatment. When the time came to report the findings, however, the researchers systematically omitted the outcomes on which the drug had no effect—and presented only the data showing benefit. That’s like dealing dozens of hands of poker to yourself but showing only the hand with good cards.

FDA ‘considers’ Antipsychotic drug labels warning of weight gain/diabetes. Considers? Do your job-issue the warnings.

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.

With 2 million kids on antipsychotics (extremely powerful/dangerous drugs) FDA finally urges review of use in kids

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.

Another Antidepressant – Another Deadly Side Effect: FDA warns Desipramine can cause sudden cardiac death

The FDA announced that Norpramin (desipramine), an antidepressant made by Sanofi Aventis can cause disturbances in the heartbeat, including sudden cardiac death in people who have a family history of this or other heart rhythm disturbances. MedWatch, the safety information arm of the FDA and the manufacturer sent this new warning to healthcare professionals.