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zoloft lawsuit

FDA notified healthcare experts about the availability of updated Healthcare Expert and Patient Data Sheets for antidepressant medicines that were the subject of Public Health Advisory issued about the threat of suicidality (suicidal thinking or behavior) in adults becoming treated with antidepressant medicines, like Zoloft.

In response to recent scientific publications that report the possibility of elevated risk of suicidal behavior in adults treated with antidepressants,like Zoloft, the FDA has issued a Public Well being Advisory to update patients and healthcare providers with the latest information on this topic. Even prior to the publication of these current reports, FDA had already begun the method of reviewing obtainable data to figure out no matter whether there is an increased threat of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide data from their trials employing an strategy similar to that utilized in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may possibly take more than a year to total.

The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by girls during pregnancy and the potential threat of a rare heart and lung condition recognized as persistent pulmonary hypertension of the newborn (PPHN). The initial Public Wellness Advisory in July 2006 on this prospective threat was based on a single published study. Considering that then, there have been conflicting findings from new research evaluating this possible danger, making it unclear whether or not use of SSRIs, like Zoloft, throughout pregnancy can result in PPHN.

FDA has reviewed the further new study outcomes and has concluded that, given the conflicting outcomes from different research, it is premature to reach any conclusion about a possible link among SSRI, like Zoloft, use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new information and the conflicting outcomes.

PPHN happens when a newborn infant does not adapt to breathing outside the womb. Newborns with PPHN could demand intensive care support which includes a mechanical ventilator to enhance their oxygen level. If serious, PPHN can result in numerous organ harm, including brain damage, and even death.

Speak to a zoloft lawyer about your potential Zoloft claim.