September, 2009FDA Orders Revisions to Januvia and Janumet Labeling for Acute Pancreatitis
The Food and Drug Administration is warning about dozens of cases of acute pancreatitis reported in people taking the Type 2 diabetes drugs Januvia and Janumet.
Continue →Antidepressant Use During Pregnancy Increases Baby’s Heart Defect Risk, New Study Finds
Another medical study has found a link between taking Prozac, Zoloft, Celexa, and other popular brands of antidepressants called selective serotonin reuptake inhibitors (SSRIs) during pregnancy and increased risks of a specific kind of birth defect of the heart.
Continue →LexisNexis® Legal News Podcast for September 25, 2009
The government has antitrust and copyright fears while author groups seek to delay a fairness hearing in the Google Library Project case, and, Chinese Drywall MDL plaintiffs and builders square off over settlement offers. Hear these and other stories from LexisNexis® Mealey’s™ Publications. Copyright© 2009 LexisNexis, a division of Reed Elsevier Inc. For the latest litigation news headlines, visit www.lexisnexis.com/mealeys.
Exjade (deferasirox) – Early Communication
Audience: Hematology-Oncology healthcare professionals
FDA notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with Exjade (deferasirox). New safety data suggests there may be a greater number…
Sitagliptin (marketed as Januvia and Janumet) – acute pancreatitis
Audience: Diabetes healthcare professionals, patients
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported…
Children’s and Infants’ Tylenol Oral Suspension Products – Recall
Audience: Consumers and Healthcare professionals
[Posted 09/25/2009] McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing problems….
Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors
Audience: Pharmacists, pediatrics healthcare professionals
[UPDATED 09/25/2009] New links added to provide information on emergency use in infants less than 1 year of age and directions to pharmacists on emergency compounding of oral suspension…
Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers
[Posted 09/24/2009] FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and…
Katrina Victims Weren’t Exposed to Toxic Fumes in FEMA Trailers, Jury Says
A federal court jury has just ruled against two survivors of Hurricane Katrina, who filed a lawsuit claiming they were exposed to toxic, cancer-causing fumes while living in government-supplied trailers after their home was damaged by the historic storm.
Continue →FDA Bowed to Industry Pressure in Approving Knee Replacement Device, Official Admits
The Food and Drug Administration threw out its own rule book and caved in to medical device company pressure in approving a knee-replacement device despite serious questions about its safety, the agency’s top lawyer said.
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