Medical researchers at Stanford University have found evidence that common heartburn medications used by millions of Americans are associated with increased risk of heart attack. The drugs are known as proton pump inhibitors (PPIs) and include Nexium, Prevacid, and Prilosec, all of which are available over the counter without a doctor prescription.
A medical panel of the US Food and Drug Administration (FDA) has recommended the agency require new warning labels for two diabetes drugs: Onglyza manufactured by AstraZeneca and Nesina by Takeda Pharmaceuticals. According to the FDA medical panel, both drugs carry increased risks of heart failure that consumers should be aware of before using them as treatment for type 2 diabetes. The FDA is not required to follow the panel’s recommendations, but it usually takes advisory committee reports into account when issuing new regulations.
The recommendation comes from the Endocrinologic and Metabolic Drugs Advisory Committee, which conducted a thorough review of DPP – 4 inhibitors, a class of drugs used to treat diabetes that contains both Onglyza and Nesina, before making its recommendation that the FDA require manufacturers to warn of the risk of heart failure. Although the FDA has not yet acted on the recommendation, the panel’s findings suggest that consumers should be aware of risks before taking the medication.
Takeda Pharmaceutical Co. is attempting to settle nearly 8,000 Actos lawsuits across the United States by agreeing to pay $2.3 billion. The settlement has been called a good deal for the drug company which will avoid the threat of further litigation and potentially punitive damages awarded to litigants who claim Actos use is linked to the development and spread of cancer. If 95% of the claimants in Actos lawsuits accept the deal, it will be finalized and Takeda will make the payment.
Each plaintiff could receive close to $300,000 to accept the settlement, but that number could change for individuals who have a history of smoking or engaging in other behavior that contributes to the cause of cancer. If accepted, Takeda’s $2.3 billion Actos settlement would be one of the larger agreements by drug manufacturers to resolve litigation.
Pharmaceutical giant Bayer recently sent out a press release announcing the continued safety of its non-surgical contraceptive, Essure. Earlier this month the New York Times published an article calling to question a study concluding Essure as a safe permanent contraceptive, prompting a public response from Bayer in defense of its product. Bayer’s public stance on Essure comes as the FDA has opened an investigation into claims of harmful side effects suffered by women who underwent the procedure.
Essure procedures were approved for use as a non-surgical alternative to permanent contraceptives in 2002, and have been since re-evaluated by the FDA in 2013 when Bayer purchased Conceptus, the company that designed the Essure device. The Essure device consists of small coils which are placed inside the fallopian tubes. Once in place the coils trigger an inflammatory response that causes scar tissue to form and block the fallopian tubes and prevent sperm from reaching the ovum. Recent legal claims against Bayer allege that manufacture and promotion of Essure has negligently put its users at risk of side effects including heavy periods, severe pelvic pain, and organ perforation.
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