STRATTERA, KIDS, SUICIDE Eli Lilly and Co. last week said it will add strong warnings to its label for Strattera, a drug used to treat attention deficit hyperactivity disorder (ADHD), including the risk of suicidal thoughts among children and adolescents.
Strattera will now carry a "black box" warning, the strongest required by U.S. regulators.
The drug maker said a review of clinical trials data identified a small but statistically significant increased risk of suicidal thoughts among children and adolescents treated with Strattera.
Strattera, which had sales last year of $667 million, is the only non-stimulant drug for attention deficit disorder approved in the United States.
Five cases of suicidal thoughts were seen among 1,357 young patients, compared with no cases among 851 patients taking placebos during trials.
PAXIL, WOMEN, BIRTH DEFECTS The Food and Drug Administration (FDA) is warning that a study suggests that Paxil may be associated with birth defects. GlaxoSmithKline, which makes the antidepressant, said it will include results of the study in the drug's list of precautions.
A retrospective study found increased numbers of babies born with birth defects to women who were taking Paxil during the first trimester of pregnancy, as compared with women on other antidepressants, according to the FDA and the company.
Doctors are advised "to carefully weigh the potential risks and benefits of using [Paxil] therapy in women during pregnancy," Glaxo-SmithKline said, adding that providers should discuss the new findings, and alternative treatments, with patients.
-- From News Services