4 results match your criteria: "Clinical Risk Management and Safety Surveillance[Affiliation]"

Varicella vaccine exposure during pregnancy: data from 10 Years of the pregnancy registry.

J Infect Dis

March 2008

Clinical Risk Management and Safety Surveillance, Merck & Co., Inc., West Point, Pennsylvania, USA.

Background: The Pregnancy Registry for Varivax (Merck) was established to monitor for congenital varicella syndrome or other birth defects in the offspring of women who were exposed to varicella vaccine while pregnant.

Methods: The registry receives voluntary reports from health care providers or consumers about women given the vaccine 3 months before or during pregnancy. Follow-up is conducted to obtain and classify pregnancy outcomes.

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Varivax (varicella virus vaccine live [Oka/Merck]; Merck), a live attenuated varicella vaccine, is indicated for vaccination against varicella in appropriate individuals > or =12 months of age. The 10-year safety profile for Varivax is described using data submitted to Merck from routine global postmarketing surveillance, combined with information from a Varicella Zoster Virus Identification Program, which uses polymerase chain reaction (PCR) analysis to identify the presence and strain of VZV in selected specimens. There were 16,683 reports worldwide voluntarily submitted to Merck, for an overall reporting rate of 3.

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Exposure to rizatriptan during pregnancy: post-marketing experience up to 30 June 2004.

Cephalalgia

September 2005

Clinical Risk Management and Safety Surveillance, Merck Research Laboratories, West Point 19486, USA.

Merck & Co., Inc. evaluates outcomes of the use of rizatriptan during pregnancy through a Pregnancy Registry in the United States (US) and spontaneous reports for pregnancies reported from sources outside the US.

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Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program.

Drug Saf

July 2004

Clinical Risk Management and Safety Surveillance, Merck Research Laboratories, West Point, Pennsylvania 19486, USA.

Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. However, there are limited data available to inform decision-making. The Merck Pregnancy Registry Program is a company-run pregnancy registry whose objective is to acquire and analyse information on drug exposures and pregnancy outcomes to better describe the safety profile of Merck products used during pregnancy.

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