Tag: Fda withdrawal

In the early 1980s, Eskatrol was among the 200 most widely prescribed drugs in the United States, marketed as a "diet pill" to aid in weight loss. However, the product was withdrawn from the market in 1981 by the U.S. Food and Drug Administration (FDA) after its manufacturer failed to prove its effectiveness.

According to a 2019 notice from the Food and Drug Administration (FDA), an abbreviated new drug application for nonsterile neomycin sulfate powder was withdrawn due to safety concerns, including ototoxicity, nephrotoxicity, and neuromuscular blockade. This decision highlights the serious risks associated with the antibiotic and explains why systemic uses of neomycin were discontinued. While topical forms containing neomycin remain available over-the-counter, its systemic administration has been largely abandoned due to these significant adverse effects.

Cisapride (Propulsid®) was voluntarily withdrawn from the U.S. market in 2000 due to numerous reports of fatal cardiac arrhythmias. Understanding how to take cisapride is therefore critical, but only applies to the very few patients who still qualify for its use through a highly restrictive compassionate-use program.

On April 7, 2005, the U.S. Food and Drug Administration (FDA) requested that Pfizer voluntarily withdraw the painkiller Bextra from the market. The decision to pull Bextra off the market was based on an unfavorable risk-to-benefit profile, driven by evidence of serious cardiovascular side effects and life-threatening skin reactions.

In 2004, Bextra was a prominent pain medication, but can you still get Bextra today? The answer is no; the FDA requested its withdrawal in 2005 due to an increased risk of serious cardiovascular events and severe skin reactions [1.3.1, 1.3.2].

In May 2024, the FDA announced the final withdrawal of approval for Truseltiq (infigratinib), a targeted therapy for bile duct cancer, just three years after its accelerated approval. This decision was voluntary on the part of the drug's manufacturer and provides a compelling case study on the risks inherent in the accelerated approval pathway.