January 22, 2007: Study Links Antidepressants to Bone Fractures in Older Patients
A new study finds that use of certain antidepressants by older patients exposes them to an increased risk of suffering bone fractures. The study, carried out by a number of Canadian research scientists, suggests that patients over 50 years of age who take Selective Serotonin Reuptake Inhibitors (SSRIs) on a daily basis -- including Celexa, Fluvoxamine, Paxil, Prozac, and Zoloft -- are twice as likely to suffer bone fractures. Read an Abstract of the Study, from the Archives of Internal Medicine.
December 5, 2006: FDA to Review Suicide Risk for Young Adults Taking Antidepressants
The U.S. Food and Drug Administration (FDA) announced a December 13 meeting of outside medical experts who will consider new data on the increased risk of "suicidality" (suicidal thinking and behavior) in young adults taking antidepressant medications. This meeting is a follow-up to two meetings on antidepressants and suicidality in pediatric patients held in February and September, 2004. The FDA states that it plans to modify antidepressant drug labels based on the panel's findings.
November 30, 2006: Physicians Advise Pregnant Women to Avoid Paxil
A national women's health care organization is advising pregnant women and women who are planning a pregnancy to avoid taking Paxil, due to concerns that use of the antidepressant may cause birth defects. In the December issue of the medical journal Obstetrics & Gynecology, the American College of Obstetricians and Gynecologists also states that the decision to prescribe any SSRI antidepressants to pregnant women -- including Lexapro, Paxil, Prozac, and Zoloft -- should be made on a case-by-case basis.
October 27, 2006: Paxil Lawsuit Reaches $63.8M Settlement
July 28, 2006: Lawsuit Filed on Behalf of Child with Severe Heart Birth Defects
The parents of a two-year-old child with severe heart birth defects filed suit in Pennsylvania State Court against Paxil maker GlaxoSmithKline. Plaintiffs allege that Paxil use during pregnancy resulted in their son's birth defects and that GlaxoSmithKline failed to warn about the risks of Paxil use during pregnancy.
July 2006: FDA Issues Two Alerts About Paxil Use
The U.S. Food and Drug Administration (FDA) issued two alerts concerning Paxil use. The first alert announced the risks associated with the combined use of selective serotonin reuptake inhibitors (SSRIs, such as Paxil) and triptans (used to treat migraine headaches). The second alert announced the risks of taking SSRIs during pregnancy. Click here to find out more about these two alerts.
May 12, 2006: GlaxoSmithKline Announces Changes to Paxil Prescribing Information
GlaxoSmithKline and the FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the "WARNINGS" section of prescribing information for Paxil and Paxil CR. These labeling changes relate to adult patients, particular those who are younger adults. The results of a recent analysis of Paxil in adult patients showed a higher frequency of suicidal behavior in young adults. However, the FDA states that the results should be interpreted with caution, since the absolute number and incidence of events are small. All reported events of suicidal behavior in adult patients with Major Depressive Disorder (MDD) were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. Click here to read more.
June 30, 2005: Suicidality in Adults Being Treated with Antidepressant Medications
The FDA issued a public health advisory announcing that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, including Paxil. The FDA advised that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins, and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications. Click here to read more.
October 15, 2004: FDA Orders Re-Labeling on Suicidality in Child and Adolescent Antidepressant Patients
In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Paxil-maker GlaxoSmithKline has since added a black box warning to Paxil prescribing information in response to the FDA advisory. Click here to read more.
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