Diabetes

September 2, 2013

Byetta, Januvia Pancreatic Cancer Lawsuits

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to consolidate all Byetta, Januvia, Janumet and Victoza cancer lawsuits, centralizing the litigation as part of an MDL, or Multidistrict Litigation. The JPML issued a Transfer Order on August 26, and these product liability cases involve pancreatic cancer after the use of Byetta, Januvia, Janumet or Victoza as part of the “Incretin Mimetics Product Liability Litigation.”

The product liability cases will be centralized before U.S. District Judge Battaglia in the Southern District of California for coordinated handling during pretrial proceedings. The consolidation is beneficial for all parties in complex pharmaceutical litigation, to reduce repetative discovery and to prevent conflicting rulings from different federal judges.

What are Incretin Mimetics?

August 12, 2013

Cancer Risk with Byetta and Januvia Downplayed by FDA

by Dr. Shezad Malik

According to the FDA, there is no scientific evidence to confirm that a group of type 2 diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer. The FDA decision comes on the heels of the European Medicines Agency, which stated that they have been unable to confirm an increased risk of pancreatic cancer linked to side effects of Byetta, Januvia, Janumet, Victoza and other incretin mimetic drugs.

The FDA has apparently completed its safety review into the new group of medications, known as incretin mimetics, and is preparing to report that it has found no conclusive connection between the medications and pancreatic cancer. According to the EMA, its experts reviewed the data and found “methodological limitations and potential sources of bias” and decided the available data don’t bear out worries about an increased risk of “pancreatic adverse events.”

The report addresses the entire group of incretin mimetics, which comprises GLP-1 agonists, which mimic a key hormone, and DPP-4 inhibitors, which interfere with a protein that breaks down the same hormone.

August 1, 2013

Lipitor and Diabetes Risk

by Dr. Shezad Malik

According to experts, the blockbuster cholesterol drug Lipitor may increase the risk of diabetes.

What is Lipitor?

Lipitor (atorvastatin) is a statin-based cholesterol drug manufactured by the Pfizer subsidiary Warner-Lambert. The cholesterol drug is a best seller and has achieved blockbuster status. Lipitor has produced more than $125 billion in sales before the patent expired in 2011. Now off patent, several generic Lipitor versions are available.

June 14, 2013

Concerns About Byetta, Januvia and Victoza Drug Safety

by Dr. Shezad Malik

The National Institutes of Health held a workshop, addressing the risks associated with the newer diabetic drugs. These medications, known as Incretic Mimetics are coming under fire for alleged increased risk of pancreatic cancer.

Merck & Co., Novo Nordisk A/S and others, the manufacturers of these drugs may be asked to collect more data on a potential cancer link even as they try to reassure U.S. regulators this week of the drugs’ safety.

The Food and Drug Administration said it is considering setting up a study, either through the agency or the companies, that looks deeper into whether medicines for Type 2 diabetes, including Merck’s Januvia and Bristol Myers-Squibb Co.’s Byetta, cause pancreatic cell growth that could turn cancerous.