Monthly Archives: May 2015
FDA Inspection Results in Warning Letter to Smith & Nephew

A March inspection of the Andover, Massachusetts manufacturing facilities of medical device maker Smith & Nephew has resulted in a Food and Drug Administration (FDA) warning letter to the company based on problems uncovered the inspection. The inspection took place … Continue reading
Update on CareFusion Recall of AVEA Ventilators

This week, medical device maker CareFusion provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA ventilators. The AVEA ventilator is used in hospitals and health … Continue reading
$15 Million in Damages Awarded to Child for Birth Defects Linked to Depakote

This week a St. Louis jury found that a Minnesota girl’s birth defects were caused by the epilepsy medication Depakote her mother took during pregnancy and the jury awarded the child $15 million in damages. The jury returned the unanimous … Continue reading
Research Links Tylenol Use during Pregnancy to Increased Risk of Male Sterility

New research suggests that males may have a higher risk of infertility if their mothers took Tylenol for extended periods during pregnancy. A study conducted by researchers at the University of Edinburgh and published in the journal Science Translational Medicine … Continue reading
UMass Epidemiologist to Lead Study of Possible Link Between Phthalates and Breast Cancer Risk

An epidemiologist at the University of Massachusetts Amherst has received a $1.5 million grant from the National Institute of Environmental Health Sciences to study whether phthalates affect human breast cancer risk. Prof. Katherine Reeves of the UMass School of Public … Continue reading
Health Authorities Investigate Multistate Salmonella Outbreak Possibly Linked to Raw Tuna in Sushi

The Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), and state and local health officials are investigating a multistate outbreak of Salmonella Paratyphi B variant L(+) tartrate(+) infections, possibly linked to sushi made from raw tuna. … Continue reading
Acetaminophen Use in Pregnancy Could Affect Son’s Fertility

New research in mice suggests that long-term exposure to acetaminophen during pregnancy could lower a male’s production of testosterone, possibly affecting his fertility. The results suggest that if a pregnant woman takes acetaminophen for several days it could affect her … Continue reading
Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago

The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks. In 2009, after duodenoscopes were linked … Continue reading
Lumber Liquidators CEO Unexpectedly Resigns Amid Product Safety Concerns

Lumber Liquidators CEO Robert Lynch unexpectedly resigned Thursday following weeks of struggles over safety concerns related to its flooring products. The Toano, Va.-based company will search nationally for a replacement, the company said. Thomas Sullivan, Lumber Liquidators founder, will serve … Continue reading
Indian Food Inspectors Order Instant Noodle Recall over Dangerous Levels of Lead

Food inspectors in the northern Indian state of Uttar Pradesh have ordered Nestle India to recall a batch of Maggi instant noodles from stores across the country because the product contained dangerous levels of lead. India’s Food Safety and Drug … Continue reading