Postmarketing Surveillance of Pregnancy Outcomes With Dolutegravir Use

Postmarketing surveillance of medications and pregnancy outcomes: clarithromycin and birth malformations.

PURPOSE This retrospective surveillance study used linked administrative claims data and medical records to determine the rate and types of birth malformations in infants born to women exposed to the antibiotic, clarithromycin (Biaxin), during the first trimester of pregnancy. METHODS Pharmacy and hospital claims from eight geographically diverse health plans were used to identify women who h...

Postmarketing surveillance of injury countermeasures.

Postmarketing surveillance for drug abuse.

Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested. The two specific surveillance systems are compared with limitations highlighted. Postmarketing surveillan...

Postmarketing surveillance of suicidal adverse events with pediatric use of antidepressants.

OBJECTIVE The aim of this analysis was to delineate trends in spontaneous postmarketing reporting data with antidepressant drugs for adverse events involving suicidal behaviors in children and adolescents. METHODS The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) was searched for postmarketing adverse event reports of suicidal thoughts and behaviors occurring i...

Duloxetine and Pregnancy Outcomes: Safety Surveillance Findings

BACKGROUND Duloxetine hydrochloride is approved for the treatment or management of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain, and fibromyalgia in the United States. These conditions affect millions of women, including those of childbearing potential. In pregnancy, pharmacological treatment is justified only if the...