FDA Reveals Over 6 Million Previously Hidden Medical Device Adverse Event Reports
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…
FDA & Prescription Drugs
FDA Says Allopurinol—not Uloric—Should be First-Line Treatment for Gout
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…
FDA Consulted with Expert Panel Before Requiring Black Box Warning on Uloric
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…
FDA Warns Xeljanz May Increase Risk of Blood Clots and Pulmonary Embolism
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…
FDA Warns of Deadly Side Effects with Gout Medication Uloric
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…
More Birth Control Pills Recalled for Potential Packaging Errors
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…
Family Found to Have Met Burden of Proof that Gardasil Caused Daughter’s Death
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…
Lemtrada and Campath Linked with Serious Types of Stroke, FDA Warns
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…
Canada, Not U.S., Receives Official Warning About Tasigna Atherosclerosis
The FDA approved Tasigna (nilotinib) in 2007 for the treatment of chronic myelogenous leukemia (CML). A few years later, however, studies revealed a link between…
Janssen Recalls 3 Lots of Ortho Birth Control Pills for Misprinted Instructions
Janssen Pharmaceuticals recently announced the recall of one lot of Ortho-Novum 1/35 birth control pills and two lots of Ortho-Novum 7/7/7 birth control pills. The…