Tag Archives: FDA

FDA Issues Label Changes for Antipsychotic Drugs—Outlining risks for newborns whose mothers took drug

The U.S. Food and Drug Administration has notified health care providers that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels include additional and consistent information regarding the potential risk for abnormal muscle movements (extrapyramidal signs [EPS]) and withdrawal symptoms among newborns whose mothers received the drugs in the third trimester of pregnancy.

After surviving war in Iraq, U.S. troops now being killed by Big Pharma

They survived live fire, explosive devices, terror attacks and grueling desert conditions. But upon returning home to seek treatment for the mental anguish that too often accompanies war, U.S. soldiers are now being killed by the pharmaceutical industry in record numbers.

A recent example is found with the late Senior Airman Anthony Mena, who returned home from Baghdad only to be killed by a toxic cocktail of prescription medications in his apartment in the USA. As the New York Times reports, a toxicologist found eight prescription medications in his blood

FDA Advisory Panel Recommends Electroshock Machine Too Risky For Reclassification to Less Dangerous Device

The Neurological Devices Advisory Panel of the U.S. Food and Drug Administration (F.D.A.), recommended Friday that devices used to deliver shock treatment, also known as electroconvulsive therapy (ECT) remain in the most high-risk category (Class III), reserved for the most dangerous medical devices and not be downgraded to a lower risk category. In so doing, it recommended that the companies which manufacture ECT devices be required to prove that ECT is both effective and safe in order to remain in use. ECT has long been known to cause serious harm to patients, including extremely severe and permanent memory loss, inability to learn and remember new events, depression, suicide, cardiovascular complications, prolonged and dangerous seizures and even death.

Not the Only Psychiatrist Who Opposes ECT

by Dr. Peter Breggin—The FDA is proposing to move ECT from the high risk category to the medium risk category to avoid the necessity of any testing for safety or efficacy. As a result, ECT would be grandfathered into continued use without ever being tested. This would place ECT in the same category as syringes which no longer need proof of safety or efficacy. The FDA hearings will be held January 27-28, 2011, and I hope some of my more courageous colleagues will attend and testify against approving ECT without testing.
ECT causes closed head injury by means of electrically-induced seizures. There can be no doubt that the treatment causes trauma to the brain. The patient is comatose for several minutes in the recovery room and after a few treatments becomes confused and disoriented. A recent study confirms long-term memory loss and other cognitive deficits, which by definition is dementia. As I review in Brain-Disabling Treatments in Psychiatry (2008, pp. 237-241), large animal studies have shown brain cell death using ECT dosages less than those routinely inflicted today. My website has a very extensive ECT bibliography that can be downloaded for free. It includes a variety of the original large animal ECT research projects.