Amidst rising concerns that some medications may be contaminated with a potential cancer-causing agent, Zantac manufacturer Sanofi recently announced a recall of the heartburn medication in both the United States and Canada. The company stated it was initiating a voluntary recall “as a precautionary
On September 24, 2019, the Food and Drug Administration (FDA) alerted healthcare professionals and the public to a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz, Inc. The medication helps decrease stomach acid, and is used to treat ulcers, reflux esophagitis,…
According to a recent report by the Centers for Medicare and Medicaid Services (CMS), doctors and hospitals received even more money in 2018 from pharmaceutical and medical device manufacturers than they did in 2017. These payments were for things like doctor speaking and consulting fees,…
In February 2019, the FDA warned that the gout medication Uloric (febuxostat), manufactured by Takeda Pharmaceuticals, created an increased risk of death from all causes. Takeda was required to place a high-level black box warning on the drug to warn patients and doctors about the…
For about 20 years, the FDA has allowed some medical device manufacturers to shield reports of problems with their devices from the public eye. This was done through the “alternative summary reporting (ASR)” program, which began in October 1997. Typically, companies must report adverse events…
Pharmaceutical company Takeda recently suffered a blow when the FDA determined that their medication, Uloric (febuxostat), should no longer be recommended as a first-line treatment for gout. After reviewing the data from a post-marketing trial required as a condition of Uloric’s approval, the FDA an
When the FDA first approved the gout medication Uloric (febuxostat) in 2009, they required a warning be placed on the label that alerted doctors and patients to a potential increased risk of cardiovascular events such as heart attack and stroke. However, clinical trials that manufacturer…
The FDA recently warned that patients with rheumatoid arthritis (RA) who are taking the 10 mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) may be at an increased risk for blood clots and pulmonary embolism. The FDA has not approved this dosage for patients with…
On February 21, 2019, the FDA released a new safety communication concerning the gout medication, Uloric (febuxostat), manufactured by Takeda Pharmaceuticals. This was an update to a previous communication in which the FDA notified the public that they were evaluating Uloric for possible connections
On March 4, 2019, the FDA announced that Apotex—a Weston, Florida company—is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol birth control tablets. The packs may contain incorrect tablet arrangements and/or be missing tablets. As a result of the error, patients may unknowingly
When their 21-year-old daughter died unexpectedly in 2008, shortly after receiving the Gardasil human papillomavirus (HPV) vaccine, the Tarsell family blamed the vaccine for the tragedy and sought to hold the vaccine maker, Merck, accountable. They investigated the case and learned that their daught
On November 29, 2018, the FDA warned about a rare but serious life-threatening risk of stroke and artery rupture in patients taking the multiple sclerosis (MS) drug Lemtrada (alemtuzumab). Since the drug’s approval in 2014, a total of 13 patients so far have reported these…
