The U.S. Food and Drug Administration on Jan. 8 approved another diabetes drug. One should hope that patients and their physicians will not be blindsided with serious unforeseen increased risks of using the drug, which has happened with diabetes drugs before.
The FDA earlier this month approved the AstraZeneca and Bristol-Myers Squibb drug Farxiga (dapaglifozin). The tablets, according to the agency, “improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.”
Thousands of patients who were treated with the diabetes drug Actos learned the hard way, instead of through proper warnings, that Actos was associated with an increased risk of bladder cancer. Indeed, as of Dec. 16, the U.S. Judicial Panel on Multidistrict Litigation had centralized 2,692 pending Actos lawsuits before the U.S. District Court for the Western District of Louisiana.
Farxiga, on the other hand, comes with the warning that Actos patients wish they had known. “An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer,” the FDA’s announcement read.
Maybe Farxiga will not catch patients off guard the way a diabetes drug containing sitagliptin did. The FDA approved Januvia in 2006 only to announce in 2009 that the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) would be revised to incorporate “information on reported cases of acute pancreatitis in patients using these products.”
Today, albeit too late for thousands of victims, some of whom have filed Januvia lawsuits, a part of the drug’s prescribing information reads, “Serious side effects can happen in people who take Januvia, including pancreatitis, which may be severe and lead to death.”
Januvia is in a class of medications known as incretin mimetics. Since March 14, 2013, the FDA has been “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes” who were treated with incretin mimetics such as Januvia.
People who have filed Actos lawsuits and Januvia lawsuits were let down. The manufacturers either knew or should have known about the increased risks and should have alerted patients and health care providers. Without proper warnings, patients took risks of which they were unaware.
We should only hope that all of the warnings are in place this time, unlike with Actos and Januvia. The disease the patients deal with is serious enough.
“Type 2 diabetes,” the FDA wrote, “affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.”