Despite Increasing Injury Reports, Mounting Lawsuits, and Growing Data, FDA, EMA Will Not Confirm Increased Pancreatic Side Effects with Incretin Drugs

increting_drugs_side_effectsThe U.S. Food and Drug Administration (FDA) agrees with the European Medicines Agency (EMA) that prevailing data concerning Type 2 diabetes medications in the class known as glucagonlike peptide-1 (GLP-1)-based diabetes therapies, do not confirm increased pancreatic side effect risks, according to an FDA spokeswoman, wrote Medscape Medical News.

“There is no change in evidence regarding the risks,” concluded the EMA’s Committee for Medicinal Products for Human Use (CHMP). The Committee recently finalized a review of GLP-1-based diabetes therapies, which are also known as incretin mimetics. These comprise 2 classes of medicines: GLP-1 agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors, MedScape Medical News explained.

Incretin mimetics include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin). Incretin mimetics include natural substances that lower raised blood sugar levels. The drugs are used in patients diagnosed with abnormally low insulin levels or patients whose bodies do not utilize insulin efficiently. These drugs imitate the body’s incretin hormones, which stimulate the release of insulin after meal consumption.

Meanwhile, a recently published piece in the journal BMJ, revealed that incretin mimetics might be riskier than first thought. The report also indicated that drug makers have withheld data on the potentially dangerous effects of incretin mimetics. After analyzing thousands of pages of regulatory documents it obtained under Freedom of Information rules, BMJ located unpublished data that indicated “unwanted proliferative or inflammatory pancreatic effects,” associated with use of incretin mimetics.

On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions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. Cohen noted that drug makers have not conducted critical safety studies and regulators have never requested these studies, according to MedPage Today. She also noted that access has been denied to the raw data that would have shed light on the safety of incretin mimetics.

The piece presents what MedPage Today describes as a “thorough timeline of incretin mimetic-related events,” that begins with the early signs of pancreatic risk seen in the drug class, which was the brought to the attention of United States and European regulators; boxed warnings discussing pancreatitis; UCLA’s Peter Butler, MD’s work exposing risks associated with incretin mimetics; as well as data from other studies.

Dr. Butler tested then-new diabetes medication, Januvia, and, in 2008, observed that the drug causes some pancreatic changes that are precursors to pancreatic cancer, according to a The New York Times report. “I knew some stuff that I thought was a worry and I was obliged to pursue it,” Dr. Butler, the chairman of endocrinology at the UCLA, told the Times. Based on Dr. Butler’s study, the FDA and EMA began investigations on the drugs.

In separate reviews, Dr. Butler and colleagues, Public Citizen, and the Institute for Safe Medication Practices (ISMP) each found many more cases of pancreatitis and pancreatic cancer reported for the incretin drugs than for Avandia, another Type 2 diabetes drug, the Times said.

A study published March 22, 2013 in the journal, Diabetes, revealed abnormal changes, such as precancerous lesions, in the pancreases of eight organ donors who had taken GLP-1-based medications when compared with patients who took other diabetes medications, according to Medscape Medical News.

More than 100 lawsuits representing 575 plaintiffs nationwide allege injury—typically pancreatitis—due to Byetta, according Bristol-Myers’ latest quarterly regulatory filing; 43 lawsuits claim that Januvia caused pancreatic cancer, according to Merck, wrote The Times.

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