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Zofran Birth Defects

WHAT YOU NEED TO KNOW Zofran (ondansetron) is a powerful anti-nausea medication marketed by GlaxoSmithKline. It was approved in 1991 to treat nausea and vomiting in patients undergoing surgery and chemotherapy. Although it is not approved for use...

Posted February 18, 2015 | by victorlongo |in Uncategorized

FDA Review of Pain Medication During Pregnancy

The following is a Drug Safety Communication from the FDA: The U.S. Food and Drug Administration (FDA) is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain...

Posted January 10, 2015 | by victorlongo |in Uncategorized

FDA Warns Chemotherapy Drug May Cause Intoxication After Treatment

FDA Drug Safety AnnouncementThe U.S. Food and Drug Administration (FDA) is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during...

Posted June 20, 2014 | by victorlongo |in Uncategorized

FDA Discourages Use of Morcellation in Hysterectomy

In a recent U.S. Food and Drug Administration (FDA) Safety Communication, the agency stated that they are concerned about women undergoing laparoscopic power morcellation for the treatment of uterine fibroids and the risk of inadvertent spread of...

Posted May 20, 2014 | by victorlongo

Insomnia Drug May Cause Next Day Impairment

FDA Drug Safety Announcement — The U.S. Food and Drug Administration (FDA) is warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. As a result, we have...

Posted May 16, 2014 | by victorlongo |in Uncategorized

Blood Glucose Test Strips May Report False Results

The FDA is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. The FDA recommends the use of alternative glucose test strips...

Posted April 30, 2014 | by victorlongo |in Uncategorized

Artelon Spacer Issues Reported

The U.S. Food and Drug Administratin (FDA) has received multiple complaints from patients implanted with the Artelon CMS Spacer, a thumb spacer implanted to treat early and mid-stage osteoarthritis. Problems reported include: Reduced...

Posted April 3, 2014 | by victorlongo |in Uncategorized

FDA warns consumers not to purchase or use weight loss product Alli

FDA Drug Safety Communication Concerning Weight Loss Product Alli From the FDA – The U.S. Food and Drug Administration is alerting consumers that GlaxoSmithKline (GSK) is withdrawing all lots of its weight loss product Alli from the U.S...

Posted March 29, 2014 | by victorlongo |in Uncategorized

Philips Respironics Initiates Recall of Trilogy Ventilator

Respironics, Inc. has announced a worldwide recall of approximately 600 Philips Respironics Trilogy Ventilators. The voluntary recall is meant to address a potentially defective component on the Trilogy Ventilator power management board, which...

Posted March 1, 2014 | by victorlongo |in Uncategorized

FDA to Review Possible Risk of Heart Failure Associated with Diabetes Drug

The U.S. Food and Drug Administration (FDA) recently released a safety announcement stating that they have requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between the use of the type 2...

Posted February 12, 2014 | by victorlongo |in Uncategorized

Baxter Recalls Dialysis Solution after Discovering Mold Contamination

The U.S. Food and Drug Administration (FDA) has published details of a product recall affecting some dialysis patients. The FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to...

Posted February 1, 2014 | by victorlongo |in Uncategorized

FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-approved Testosterone Products

A possible risk of stroke, heart attack, and death in men has been linked to FDA-approved testosterone products, according to an FDA Safety Announcement. The agency, responsible for protecting the public health, has been monitoring this risk and...

Posted January 31, 2014 | by victorlongo |in Uncategorized

Tag: FDA