by: Jeff S. Gibson, Attorney
Advances in modern medicine over the past decade have given patients many great treatment options. Drugs have been designed to treat myriad of conditions from heart arrhythmia to kidney disease. Ideally, drug manufacturers have a goal to create medicine for patients that will give them maximum benefit with minimum risk. It seems that lately this ideal has been lacking. Adverse event reports have been filed with the FDA for a variety of drugs that have led to heighted patient safety warnings and recalls.
Diabetes drugs Byetta and Januvia are now being studied by the FDA for causing an increased risk of pancreatitis and other health issues which may lead to pancreatic cancer. As early as 2007, the FDA added warning information about pancreatitis to the labels of Byetta, Januvia, and Janumet. However, a recent study shows these drugs may as much as double a patient’s risk for developing pancreatic or other serious pancreas-related illnesses.
Perhaps the worst example of harm caused by a diabetes medication is Avandia, which was manufactured by GlaxoSmithKline. Researchers stated in a New England Journal of Medicine article that Avandia was associated with a 43% increased risk for heart attacks. Over 100,000 heart attacks have been linked to usage of Avandia.
GlaxoSmithKline has since agreed to pay over $700 million in settlements to patients who filed lawsuits against the company for injuries associated with the drug.
Patients have a right to be concerned about the risks associated with the diabetes drugs Byetta, Januvia, Janumet, and Victoza. Bristol-Myers Squibb, the manufacturer of Byetta, received a notice from the FDA within its first two years on the market of a need to add safety information regarding cases of pancreatitis, some fatal, to its labels. Merck, the manufacturer of Januvia and Janumet received a similar notice from the FDA within its first three years on the market. These notices were in response to adverse event reports filed with the FDA. Victoza was approved by the FDA in 2010. If this drug follows suit with the others, patients can expect the FDA to issue a safety alert for this drug soon.
Johnson & Johnson recently gained FDA approval for Invokana, the first of a new class of drugs used to treat type 2 diabetes. Early trials of the drug have indicated some cardiovascular events have occurred in patients. The manufacturer believes Invokana will be used as an option for patients who are not responding to other drug therapies including Januvia.
Given Johnson & Johnson’s checkered past with lawsuits associated with other products such as metal-on-metal hip implants, transvaginal mesh, and pharmaceuticals, the drug manufacturer needs to conduct thorough testing of this drug to help ensure patient safety. All drug manufacturers need to be vigilant in conducting efficacy and safety tests to protect consumers and not put profits ahead of people.
FDA Has Growing Concern Over Popular Diabetes Drugs
by: Jeff S. Gibson, Attorney