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Johnson & Johnson has high hopes that its recently approved diabetes drug, Invokana, will break the trend of problems that have surfaced in recent years with many newer diabetes medications, leading to lawsuits, recalls and health advisories over serious side effects.
Invokana is the first of a new class of diabetes drugs approved by the FDA on March 29 for the treatment of Type 2 diabetes. The class will be known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.
The drugs are supposed to work by blocking the reabsorption of glucose by the kidney. This should increase glucose production and lower blood glocose levels in diabetes whose levels are elevated.
The FDA has indicated that the drug went through nine clinical trials that included more than 10,000 diabetic patients as both a standalone drug and in combination with other diabetes drugs already on the market. Despite the previous clinical trials, the FDA is requiring Johnson & Johnson to conduct five postmarketing studies designed to look for heart risks, possible links to cancer and other problems that have plagued other diabetes drugs in recent years.
The new drug comes as other classes of diabetes drugs are under assault for a variety of side effects, including pancreatic cancer and bladder cancer, as well as increased risk of heart attack and liver failure.
Pancreatic Cancer Risk Linked to Byetta, Januvia, and Victoza
Before the approval of Invokana, one of the newest classes of diabetes drugs was incretin mimetics, which were first introduced in 2005. Among the blockbuster drugs in this class are Byetta, Januvia, Janumet and Victoza.
After millions of Americans were exposed to these medications, recent studies have suggested that there may be an increased risk of pancreatic cancer following use of incretin mimetics. Both the FDA and the European Medicines Agency have launched investigations to better ascertain the pancreatic cancer and pancreatitis risks.
A number of former users of these drugs who have since developed pancreatic cancer are now pursuing a Byetta lawsuit, Januvia lawsuit, Janumet lawsuit or Victoza lawsuit against the drug makers, alleging that they failed to adequately research the impact of the medication on the pancreas or warn about the risk of cancer.
Glitazones Marred By Bladder Cancer and Heart Attack Risks
Another major class of newer diabetes drugs, known as glitazones, have also been under assault in recent years. Among the members of this class of medications are Rezulin, which was introduced in 1997, as well as Avandia and Actos, which were both approved in 1999.
Rezulin was recalled in 2001, after it was linked to an increased risk of liver damage, liver failure and death. More than 35,000 diabetics filed a Rezulin lawsuit against the manufacturer, who ultimately paid about $750 million to resolve the claims.
One of the most widely used glitazones was Avandia, which is now severely restricted and was almost recalled from the market after it was linked to an increased risk of heart attacks and heart problems that surfaced in 2007. Some reports have suggested that as many as 100,000 heart attacks may have been caused by Avandia, and the drug’s manufacturer has reportedly paid more than $1 billion to settle Avandia heart attack lawsuits.
More recently, the last standing member of this class, Actos, is under fire amid reports that long-term use of the medication may increase the risk of bladder cancer.
The FDA launched a safety review of Actos in September 2010, after receiving the early data from an on-going study. The following summer, a study conducted by French insurers further increased concerns within the medical community about an increased risk of bladder cancer diagnosis following Actos use, leading to a decision to remove Actos from the market in France.
In the United States, the FDA added new warning language to the Actos warning label in August 2011, indicating that use of the drug for more than one year may increase the risk of bladder cancer.
Hundreds of individuals throughout the United States are now pursuing an Actos bladder cancer lawsuit against Takeda Pharmaceuticals, alleging that the drug maker failed to research the side effects of the drug or provide adequate warnings about the risks associated with long-term use.