The Food and Drug Administration has issue a warning about the risk of serious and potentially deadly side effects associated with the seizure and bipolar disorder drug Lamictal (lamotrigine). According to the FDA warning, patients taking Lamictal may experience an immune system response that can cause severe inflammation throughout the body, leading to hospitalization or…
Legal experts say that new rules proposed by the Food and Drug Administration regarding warning labels for generic pharmaceutical products could increase the number of product liability lawsuits against generic drug manufacturers. As a result, the proposed rules are being met with opposition from trade groups representing those companies.
Janssen Pharmaceuticals and Mitsubishi Tanabe Pharma are facing dozens of lawsuits filed by patients who suffered kidney damage or other complications linked to the diabetes drug Invokana. Attorneys representing patients who were injured after using Invokana recently filed a motion to consolidate lawsuits filed in federal and state courts against Janssen and Mitsubishi in a…
A Wisconsin federal judge has ruled that a wrongful death lawsuit filed on behalf of a patient who died after taking the arrhythmia drug Amiodarone will be allowed to move forward. Zydus Pharmaceuticals and Wyeth Pharmaceuticals, the manufacturers of the drug, had tried to have the case thrown out on the grounds that it was…
A former sales manager and sales representative at Insys Therapeutics—the manufacturer of the fentanyl sublingual spray Subsys—have been arrested by investigators on federal anti-kickback charges. Jonathan Roper and his former colleague at Insys, Fernando Serrano, are accused of making payments to doctors as part of what officials call a “sham” educational program to prescribe millions…
A new study published by Canadian researchers in the British Medical Journal (BMJ) has found that patients who use the diabetes drug Actos are 63% more likely to develop bladder cancer. Researchers also found that this Actos bladder cancer risk increases the longer that patients are treated with the drug.
A Food and Drug Administration advisory panel has unanimously voted to recommend mandatory training for doctors who prescribe opioid painkillers in order to help curb the epidemic of opioid overprescription in the U.S. The advisory panel’s recommendations would involve a complete overhaul of the current system for educating doctors and patients about the dangers of…
The Food and Drug Administration has launched an investigation into whether a faulty blood monitor may have compromised testing results that led to the agency’s approval of the bloodthinner Xarelto. Xarelto has been prescribed to millions of Americans since it was approved by the FDA and placed on the market in 2011.
Health experts say that thousands of patients each year are sickened by drug interactions that occur due to medical errors or negligence. In many cases, experts say that these errors involve drug interactions that have been known about for years, but which occur due to the failure of doctors or medical staff to properly monitor…
Fresenius Medical Care has agreed to a $250 million settlement in a multidistrict litigation (MDL) in Massachusetts over two dialysis drugs, GranuFlo and NaturaLyte. Multiple class action lawsuits had been filed against Fresenius over allegations that the company did not adequately warn patients about a potential increased risk of heart attack or stroke linked to…
A new study published by JAMA Internal Medicine has found that drug companies may delay reporting serious cases of pharmaceutical adverse events to the Food and Drug Administration, putting the safety of patients who take these medications at risk. The report found that drug companies may be even less likely to report adverse events to…
The Food and Drug Administration has issued a warning about a risk of life-threatening complications in patients taking a new class of type 2 diabetes drugs. According to the FDA warning, patients taking drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors such as Invokamet, Xigduo XR, and Glyxambi may develop high blood acid levels that could…