The Medicines and Healthcare Products Regulatory Agency (MHRA), the government agency in the UK responsible for medicines and medical devices, has issued a warning about potential SSRI birth defects related to the use of fluoxetine (Prozac). The MHRA issued the warning in its monthly drug safety update. The agency warns that there is a small risk of congenital cardiac defects in infants of mothers who took fluoxetine during the first trimester of pregnancy.
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.
“Our data should give some pause” to doctors and patients weighing antidepressants, Robert DeRubeis, a psychologist at the University of Pennsylvania, Philadelphia, said in a telephone interview. “They should give some consideration to other alternatives.” Exercise has been shown to be helpful to stem depression, as does psychotherapy, and even “self-treatment” with the aid of the plethora of self-help literature, he said.
It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid the risk to increase profits. Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk.
Where once drugs were seen as poisons to be used judiciously and with caution, they are now treated as fertilisers whose more or less indiscriminate use can only do good. Where once farmers knew to keep their cattle out of fields growing the serotonin reuptake inhibiting weed, St John’s Wort, as it caused miscarriages, under industry influence women have been herded by doctors in exactly the opposite direction.