Paxil, an antidepressant drug, may increase the risk of birth defects for pregnant women taking it during the first trimester, the Food and Drug Administration warned last week.
The warning comes after Paxil manufacturer GlaxoSmithKline sent the FDA and doctors a letter about preliminary results from a study suggest an increase in the risk of congenital […]

A lawsuit seeking class action status has been filed in the U.S. District Court for the Southern District of New York on behalf of all persons who purchased the publicly traded securities of GlaxoSmithKline plc between February 21, 2001 and August 5, 2004 (the “Class Period”).
The lawsuit, filed by the law firm of Schatz & […]

The Food and Drug Administration on Friday halted distribution of supplies of antidepressant Paxil CR and diabetes drug Avandamet because of concerns about manufacturing and quality.
FDA officials said manufacturing practices for the two drugs, made by British-based GlaxoSmithKline, failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity.
However, […]

All antidepressants must carry a “black box” warning to describe the risk and emphasize the need for close monitoring of children and adolescents being treated with antidepressant medications, the U.S. Food and Drug administration said Friday.
The Public Health Advisory is part of a multi-pronged strategy to warn the pubic about the increased risk of suicidal […]

Antidepressant drugs like Paxil, Zoloft and Prozac may cause some children and adolescents to have suicidal thoughts and actions, U.S. Food and Drug Administration officials said on Monday.
“I think that we now all believe that there is an increase in suicidal thinking and action that is consistent across all the drugs,’ Dr. Robert Temple, director […]

The United States House of Representatives’ Congressional Oversight and Investigation Committee on Thursday was scheduled to hold a Hearing on “Antidepressants and Children” in Washington, D.C.
The Committee is investigating what the Food and Drug Administration and pharmaceutical makers knew about the safety of antidepressants before the drug industry began issuing warnings about the effects of […]

Parents of children and adolescents who were prescribed the antidepressant drug Paxil are filing lawsuits against Europe’s largest drug maker GlaxoSmithKline following claims the company concealed information about the safety and effectiveness of Paxil in treating young people with depression.
The lawsuits are the latest of legal battles for GSK.
In August the company agreed to […]

GlaxoSmithKline last week agreed to pay $2.5 million to settle charges from the New York Attorneys General’s office that it had concealed information about the safety and effectiveness of Paxil in treating children and adolescents with depression.
As part of the agreement, GlaxoSmithKline (GSK) will become the first major drug manufacturer to publicly disclose information […]

Patients on antidepressant drugs like Prozac and Paxil are prone to suicidal tendencies when they are first put on antidepressants, according to a study published in Wednesday’s issue of Journal of the American Medical Association.
The study, by Drs. Herschel and Susan Jick and James Kaye at Boston University, looked at Prozac, Paxil, amitriptyline and dothiepin […]

New York State Attorney General Eliot Spitzer filed a civil lawsuit against the British-based pharmaceutical giant GlaxoSmithKline last week, accusing the company of concealing information about the safety and efficacy of its popular anti-depressant drug Paxil.
The lawsuit, filed in New York State Supreme Court in Manhattan, alleges that GSK engaged in repeated and persistent fraud […]