Tag Archives: black box warning

The Huffington Post: “Pilots Taking Antidepressants? The FAA Is Risking Our Lives”

A few years ago I was hired by the FAA to defend the agency against a suit brought by a pilot who wanted to fly while taking a prescription antidepressant. I helped the FAA formulate its defense of the agency’s ban on pilots using antidepressants and, as a result, the ban remained in effect. Pilots remained unable to fly while taking antidepressants, including the newer ones such as Prozac, Paxil, Zoloft, Celexa, Lexapro and Effexor. How times have changed.

Child/Teen Suicide Rate 5 Times Higher for Kids on Antidepressants; Researchers Say findings support FDA Black Box Warnings

The heightened risk of teen suicide doesn’t vary among users of different antidepressants, a new study finds. Researchers say the finding supports the FDA’s current “black box” warning on all antidepressants detailing the increased risk of suicide attempts and suicides in children and teens who start to take the drugs. A “black box” warning is the FDA’s most severe warning label.

Kickbackers’ motto: ‘Do no harm’ (to profits)—How drug company used kickbacks to get patients on psych drugs

TALK ABOUT death panels. The US attorney in Boston recently filed suit against the world’s largest maker of health products, Johnson & Johnson, for using kickbacks to get more nursing home patients onto its drugs, including one that was later found to be so lethal to the elderly it had to carry a black-box warning. The government’s complaint leaves little doubt that the drug company acted in a predatory way to increase sales and market share for its products, especially Risperdal, an antipsychotic often used to keep Alzheimer’s and dementia patients under control.

FDA misleads again: Admits SSRI/suicide link for 25 & under but not adults

The FDA analysis by Dr. Marc Stone, Dr. Thomas Laughren and colleagues involved a review of data from eight drug makers on 372 clinical trials involving nearly 100,000 adults.

Overall, they found the risk of suicide was “strongly age-dependent,” with higher risks in people under 25, no difference among those 25 to 64, and lower risks in people 65 and older.