Update: FDA to Investigate Janumet / Rhabdomyolysis Link
December 1, 2017 – The FDA is considering taking regulatory action over Janumet and other diabetres drugs in its class after finding an increased risk of rhabdomyolysis with the drugs, according to a surveillance report issued October 4. Rhabdomyolysis is a severe, potentially irreversible condition that occurs when the skeletal muscle deteriorates rapidly, causing leakage into the urine of the muscle protein myoglobin.
What is Janumet?
Janumet is a medication that treats type-2 diabetes. It was developed by Merck & Co. and approved by the U.S. Food and Drug Administration (FDA) in 2007. It contains a combination of the following drugs:
- Sitagliptin: Sold alone under the brand-name Januvia, sitaglitpin is a DPP-4 inhibitor that stimulates the pancreas to make more insulin, which results in better blood-sugar control.
- Metformin: Decreases the amount of glucose (sugar) produced by the liver and increases the body’s sensitivity to insulin.
Janumet Lawsuits Centralized in California
Merck is facing a growing number of Janumet lawsuits involving plaintiffs who were injured by pancreatic cancer. Established in August 2013, the litigation contains over 360 lawsuits involving diabetes drugs, including Janumet, Januvia, Byetta, and Victoza. These lawsuits are overseen by Judge Anthony J. Battaglia in the U.S. District Court for the Southern District of California:
- In re: Incretin Mimetic Product Liability Litigation
Janumet and Pancreatitis
In September 2009, the U.S. Food and Drug Administration (FDA) published a Safety Communication after linking Janumet to 88 reports of pancreatitis (pancreatic inflammation), including hemorrhagic and necrotizing pancreatitis.
Janumet and Pancreatic Cancer
Pancreatitis, a known side effect of Janumet, is also a major risk-factor for pancreatic cancer. Furthermore, Janumet contains sitagliptin, which was associated with a 2.7-fold increased risk of pancreatic cancer in a study published in Gastroenterology in 2011.
Since then, evidence linking Janumet and pancreatic cancer has continued to grow. In March 2013, Diabetes published a study linking sitagliptin to pre-cancerous growths in several pancreases that were autopsied. In response, the FDA issued a Safety Communication and launched an investigation.
Symptoms of pancreatic cancer:
- Abdominal pain
- Jaundice (yellowing of skin, eyes)
- Weight loss
- Nausea, vomiting
- Diarrhea, indigestion
- Dark-colored urine
- Malaise (generally feeling unwell)
- And more
Janumet Thyroid Cancer
Experts are concerned about a possible link between Janumet and thyroid cancer because several drugs in the incretin mimetic class have been associated with this disease. Victoza and Bydureon, for example, carry Black Box warnings about the potential risk of thyroid cancer. In addition, Janumet is a DPP-4 inhibitor, which may decrease the body’s natural defenses against all types of cancer.
Janumet Side Effects
- Pancreatic inflammation
- Hemorrhagic pancreatitis
- Necrotizing pancreatitis
- Pancreatic cancer
- Thyroid cancer
- Kidney failure
- Joint Pain
FDA Warns of Severe Joint Pain with DPP-4 Inhibitors
On August 28, 2015, FDA issued a Drug Safety Communication warning that diabetes drugs from the DPP-4 class may cause severe and disabling joint pain in some people. Symptoms began from 1 day to several years after taking the medications, and most resolved in less than a month after quitting.
Skin Complications (Bullous Pemphigoid)
Nesina and other diabetes drugs from the DPP-4 inhibitor class have recently been linked to a rare skin disorder called bullous pemphigoid. Investigators at Western Michigan University, Kalamazoo, conducted a literature review and an analysis of the FDA’s Adverse Event Reporting System database and concluded there is a link between DPP-IV inhibitors and the development of bullous pemphigoid, a potentially fatal cutaneous autoimmune blistering disorder. The skin disease appeared after an average of 6 months on DPP-IV inhibitor therapy in their series. In most cases the condition remitted in response to discontinuation of the drug, often in conjunction with a course of topical or less frequently, oral corticosteroid therapy.
Do I have a Janumet Class Action Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Janumet lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Janumet Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by Janumet, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit, and we can help.