Washington, DCThree recent studies have indicated an increased risk of Januvia cancer and Januvia pancreatic cancer in particular.
One recent study published in the BMJ (British Medical Journal) has found growing safety concerns with the diabetes drug, and data indicates that Januvia could be riskier than first believed. That data included a review of health insurance claims, which showed a higher risk of hospital admission for acute pancreatitis in patients taking Januvia when compared to other diabetes medications. It also revealed a review of FDA data showing increased pancreatitis and pancreatic cancer risks in patients taking incretin mimetics - Januvia is included in this class of drugs.
The esteemed BMJ was able to obtain thousand of regulatory documents under the Freedom of Information Act and rules. The Journal was able to locate unpublished data indicating “unwanted proliferative or inflammatory pancreatic effects.”
“On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” wrote Deborah Cohen, Investigative Editor for BMJ.
The report goes further, indicating that drugmakers did not conduct proper safety studies and that regulators have not even requested such critical studies. Cohen also wrote that access to the raw data - that would have shown the safety of incretin mimetics - has been denied.
“Instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data,” said BMJ Editor-in-Chief Fiona Godlee, MD, to MedPage today. “Meanwhile, patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.
“The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors, and, ultimately, patients could make up their own minds,” said Godlee. And arming patients with all the information could save lives.
As of July 14, 2013, there have been 43 Januvia pancreatic cancer lawsuits filed, according to Merck, the manufacturer. Court records indicate that the US Judicial Panel on Multidistrict Litigation (JPML) is now considering consolidation of all federal Januvia lawsuits, including claims involving similar diabetes drugs in the same incretin mimetics class, in a single federal court for pretrial proceedings.
More than 50 product liability claims involving incretin mimetics, including Januvia pancreatic cancer lawsuits, have been filed in federal courts around the country, according to Court records. The JPML will hear Oral Arguments on the possible consolidation of those claims on July 25.
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