Diabetes drugs taken by millions of Americans may be linked to an increased risk of pancreatitis and pancreatic cancer (a disease with one of the lowest cancer survival rates). More than 12 million prescriptions were filled, in the United States, in 2012 alone. These increasingly popular GLP-1 (glucagon-like peptide) drugs (such as Byetta and Victoza) and DPP-4 drugs (such as Junuvai, Onglyza, Nesina and Tradjenta or Trajenta) should be added to the list of diabetes drugs like, Avandia and Actos, among others, that have recently been the subject of causing serious and deadly side effects. Back in April 2012, Public Citizen’s Health Research Group (HRG) petitioned the FDA to ban Victoza after studies found “it puts patients at higher risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure that outweigh any documented clinical benefits.”
The U.S. Food and Drug Administration (FDA) issued a stern warning to patients who take Janssen Pharmaceutical’s Nizoral (generic name ketoconazole) oral tablets. In fact, the FDA issued a safety release advisiong that Nizoral should not be the initial treatment for any fungal infection. During 2012, approximately 5.2 million ketoconazole prescriptions were dispensed, of which 609,000 were for tablet formulation.
In early June, Medtronic issued an urgent notification to patients and medical professionals concerning a “potential for over or under delivery of insulin if insulin or other fluids contact inside of Medtronic Paradigm Infusion Set Connectors.”
According to a study by the Fred Hutchinson Research Center, there is a link between high concentrations of omega-3 fatty acids and an increased risk of prostate cancer.
A federal judge has opened a window for plaintiffs to make a claim for strict liability against prescription drugmakers on a manufacturing defect theory. Despite developing case law in the opposite direction, U.S. District Judge Malachy Mannion of the Middle District of Pennsylvania ruled that Ryan Bergstresser could bring a manufacturing-defect claim against Bristol-Myers Squibb over its antipsychotic drug, Abilify. Bergstresser alleges he suffered from dystonia, which is characterized by involuntary muscle contractions, after his psychiatrist increased his dosage of the drug.
On April 30, 2013, the Food and Drug Administration (FDA) issued their second alert to patients and health care providers concerning the drug tolvaptan (SAMSCA). The warning had two main points: Tolvaptan use should be limited to no more than 30 days, and it should not be used at all in patients who have liver disease.
On March 14, 2013, Fresenius Medical Care North America (FMCNA), announced that it has received yet another reprimand from the FDA, indicating that the agency found that the company failed to properly study artificial kidneys being used in its dialysis machines. The letter is not a formal recall, but it comes in the wake of the mid-2012 GranuFlo and NaturaLyte dialysis product recalls. These products were recalled when it was revealed that there is a serious and high risk of sudden cardiac arrest or death due to elevated bicarbonate levels in these dialysis additives
Prolia, a drug used to treat osteoporosis, received FDA approval in June of 2010. Prolia is administered by injection every six months to postmenopausal women and to men, who have either low bone mass or osteoporosis, and are susceptible to fractures.
The FDA issued a warning for the popular antibiotic (azithromycin) commonly known as a Z-Pack and sold under the brand names Zithromax and Zmax. This common antibiotic is widely used to treat sinus infections and bronchitis. In 2011 alone, there were over 50 million prescriptions for the Z-pack with sales in excess of 464 million dollars.
On March 5, 2013, Pogust Braslow & Millrood, LLC filed its first personal injury suit against Eli Lily and Company over Cymbalta withdrawal symptoms. The case, Carnes v. Eli Lilly and Co., was filed in the United States District Court for the District of South Carolina. Cymbalta withdrawal symptoms can be severe, long-lasting, and debilitating. The complaint details that Mr. Carnes suffered from severe brain zaps and aggression, and alleges that the company should have known about the likelihood, extent, and severity of experiencing withdrawal symptoms and yet failed to adequately warn doctors and patients about the risk.
The Food and Drug Administration issued a Class 1 Recall of the orthopedic device known as the LPA Diaphyseal Sleeve. Manufactured by Depuy, Johnson & Johnson’s orthopedic unit, the LPA Diaphyseal Sleeve is used in reconstructive knee surgery.
A 2010 study, published in the American Heart Association’s journal Circulation, found that the risk for heart attacks was the same for Actos as it was for Avandia. According to the study, patients taking Actos or Avandia were 4 percent more likely to experience heart attacks. The study included over 36,000 patients with an average age of 54. This study was conducted over 33 months, including 14 months of treatment on either medication. Among the patients, 602 Avandia users and 599 Actos users suffered a heart attack, heart failure, or died. Even more concerning, there were 217 deaths in each group. Despite these alarming numbers, some found the results of this study to be inconclusive.