FDA Requests Ranitidine (Zantac) Products Be Removed from the Market
The U.S. Food and Drug Administration (the “FDA”) announced today that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The FDA… read more
Companies Recalling Zantac / Ranitidine Due to Concerns Regarding the Presence of NDMA
Zantac and generic ranitidine medications—used to treat heartburn, ulcers, gastroesophageal reflux disease (GERD), and general indigestion and stomach upset—have been the subject of several recalls over the past few months, with more expected to be forthcoming. These recalls have all been implemented after testing of ranitidine medications had confirmed the presence of high levels of… read more
New Class-Action Lawsuit Filed Against Zantac Manufacturers Because of Potential Cancer Risk
On September 26, 2019, five plaintiffs jointly filed a class-action lawsuit against Sanofi-Aventis LLC, makers of the stomach-acid medication, Zantac (ranitidine). They’ve also named as defendants Boehringer Ingelheim Pharmaceuticals, Inc., which owned the U.S. rights to Zantac and manufactured and distributed the drug from October 2006 to January 2017, after which Sanofi acquired the rights…. read more
CoaguChek Recall: What You Need To Know
Warfarin sodium (Coumadin or Marevan) is the most widely used anticoagulant in the United States. This medication is vital for patients with venous thromboembolism, chronic atrial fibrillation, valvular heart disease, and mechanical prosthetic heart valves. However, due to the risk of internal hemorrhaging, monitoring is required every one to four weeks to ensure appropriate dosing…. read more
FDA Issues Black Box Warning for Uloric
In February 2019, the FDA issued a “black box warning” – the agency’s strongest and most prominent advisory — for Takeda’s popular gout drug, Uloric. According to health regulators, Uloric (febuxostat) is associated with an “increased risk of heart-related death and death from all causes” compared to the gout medication allopurinol. The boxed warning also… read more
Infection After Taking Xeljanz? Here’s What To Do!
Designed to treat rheumatoid arthritis and ulcerative colitis, Pfizer’s Xeljanz (tofacitinib) has been linked with potentially deadly side effects, which include: Liver enzyme elevations, lipid elevations, anemia, neutropenia, and lymphocyte abnormalities Increased risk of blood clots in the lungs, causing death Perforations of the stomach or intestines Lymphoma and other cancers Non-melanoma skin cancers Hypersensitivity… read more
Is Your Medication Causing Dangerous Side Effects?
There is an old saying that sometimes the cure is worse than the disease. While medications are prescribed to treat ailments, sometimes the side effects of a drug are as dangerous – or more so – than the disease itself. The Federal Food and Drug Administration has placed “black box” labels on certain drugs– warning… read more
Can Uloric Cause a Heart Attack?
Uloric (also known as febuxostat), a gout medication, has been a “hot topic” in headlines recently due to an announcement by the U.S. Food and Drug Administration (FDA) in February 2019 that a new black boxed warning was being added to its label. At issue is the discovery that Uloric carries a significant increase in… read more
Arthritis Patients Taking Xeljanz May be at Risk for Pulmonary Embolism
Rheumatologists have a few pharmaceutical options for patients who are suffering from the effects of rheumatoid arthritis. One of those options is tofacitinib citrate, which is sold under the brand name “Xeljanz.” This drug blocks certain naturally-occurring enzymes that cause joint pain, swelling, and stiffness. A recent safety alert from the U.S. Food and Drug… read more
Uloric vs Allopurinol: FDA says Allopurinol Should be First-Line Treatment for Gout
The FDA recently determined that Takeda Pharmaceutical’s medication, Uloric (febuxostat), should no longer be recommended as a first-line treatment for gout, a type of arthritis. After reviewing the data from a post-marketing trial required as a condition of Uloric’s approval, the FDA announced that they were requiring a new black box warning on the product… read more