Tag: atypical antipsychotic
“Jury Smacks J&J with $70M in Damages in Latest Risperdal Breast...
Fierce Pharma reports: "Johnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and...
Olanzapine Can Cause Serious Skin Reaction, FDA Warns
The US FDA has issued a new warning for the atypical antipsychotic Olanzapine, also known by the brand names Zyprexa and Symbyax. The agency...
âAntipsychotic Use in Youth Without Psychosis: A Double-edged Swordâ
This monthâs issue of JAMA Psychiatry ran an editorial commenting on recent research revealing that the majority of youth prescribed antipsychotics have not been diagnosed with a mental disorder.
On Relaxing Off-Label Meds:Â Do the Opposite. Especially for Children. Especially Antipsychotics
The US Food and Drug Administration has announced that there will soon be a public meeting to explore providing drug companies with greater flexibility in promoting off-label indications to doctors. When it comes to prescribing medications to children, and particularly psychiatric medications, this is a bad idea. I write both as a former consultant to the pharmaceutical industry, and as a father who lost a son to the toxic effects of antipsychotics prescribed off-label.
Sheller’s Appeal Demonstrates FDA’s Indifference to Drug Harm
As I wrote in Letâs All Support Stephen Shellerâs FDA Petition to Revoke the Pediatric Approval of Risperdal, Stephen Sheller's law firm, which represents hundreds of boys who were prescribed Risperdal and then grew breasts (gynecomastia) as a result, filed a petition with the Food and Drug Administration (FDA) to change the label and revoke its approval for use on children. During the course of discovery for litigation in its Risperdal cases, Sheller became privy to documents not provided to the FDA that showed Johnson & Johnson hid the problem. This is a very important case. If it is successful, it will give hope of forcing the FDA to follow its mandate to protect the public from harmful drugs.
Take a ride on the Mood Elevator
These are not happy times for the embattled drug maker AstraZeneca. The patent for Seroquel has expired; the companyâs profits have plummeted; and its...