FDA Announces Recall of Popular Heartburn Drug Amidst Contamination Concerns
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…
FDA & Prescription Drugs
Pharmaceutical Companies Paid Billions to Doctors in 2018: Influencing Prescriptions?
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…
Despite Risks of Death, FDA Approves Generic Uloric
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.…
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 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…