Natazia (estradiol valerate and estradiol valerate/dienogest), a fourth generation oral contraceptive made by pharmaceutical giant Bayer HealthCare Pharmaceuticals, Inc, was FDA-approved on March 15, 2012, for the treatment of heavy menstrual bleeding. In February 2012, the FDA gave Natazia a Black Box Warning regarding “Thromboembolic Disorders and Other Vascular Problems.”…
According to a medical study, patients who received metal-on-metal hip replacements are at no greater risk of developing cancer after a seven-year period than the general population. The research is published in the British Medical Journal, and recommends that longer-term review is needed of the effect of metal particles released…
The blood thinner Pradaxa, (subject of 6 wrongful death US lawsuits), according to a new FDA report, may have been responsible for another 117 deaths during the second quarter of 2011. The Institute for Safe Medication Practices (ISMP) published their quarterly report (PDF) earlier this week on adverse event reports…
A New Jersey State court will begin the first bellwether trial for NuvaRing lawsuits in February of 2013. These bellwether trials will reach a jury, out of hundreds of cases brought by women who allege the birth control ring increases the risk of blood clot (venous thromboembolism) injuries. A group…
There is a new warning from the U.K. health officials, that states patients who received combination DePuy MITCH and Stryker Accolade metal-on-metal hip replacement components are experiencing a high failure rate. The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert (pdf) on April 2, stating…
In December of 2011, The U.S. Food and Drug Administration (FDA) issued a safety announcement, that it was “evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular…
Federal drug regulators are expanding the warnings over the potential heart risks of Celexa, with new dosing instructions for the elderly and people with liver problems. The FDA issued a new Celexa drug safety communication on March 28, limiting the maximum dose as 20 mg for patients over the age…
According to federal drug regulators, Merck failed to conduct requested testing on their popular diabetes drugs Januvia and Janumet, which was designed to assess the risk of pancreatis from Januvia and Janumet. The FDA issued a warning letter to Merck on February 17, and the FDA indicated that Merck failed…
According to new medical research, Byetta and Januvia may cause increased risk of pancreatitis and pancreatic cancer. A medical study in 2011 found that users of Januvia and Byetta may be six times more likely to be diagnosed with pancreatitis and three times more likely to develop pancreatic cancer. Byetta…
An initial conference has been set for April in the federal multidistrict litigation (MDL) involving all lawsuits over Wright Medical metal-on-metal hip replacements. In February, the U.S. Judicial Panel on Multidistrict Litigation centralized the Wright Medical hip replacement lawsuits in the U.S. District Court for the Northern District of Georgia.…