Posted by on Jan 9, 2014 in Defective Products | 2 comments

Sitagliptin, which is marketed as Januvia in the US, has been approved by the U.S. Food and Drug Administration for use by adults suffering from type 2 diabetes mellitus. This dipeptidyl peptidase-4 (DPP-4) inhibitor or diabetic drug was intended as an addition to exercise and diet to help improve the control of blood sugar level. This oral anti-diabetic drug (anti-hyperglycemic) was introduced by Merck & Co. and earned FDA approval on October 17, 2006. The FDA, likewise, permitted Sitagliptin to be combined with metformin and to be marketed under the name Janumet.

Compared to placebo and other type 2 diabetes drugs, this enzyme-inhibiting Sitagliptin or Januvia is known to cause fewer side-effects, such as lesser gain in weight and hypoglycemia. The enzyme that Januvia specifically inhibits is dipeptidyl peptidase 4 (DPP-4), which breaks down the Gastric inhibitory polypeptide or GIP and glucagon-like peptide-1 or GLP-1 (GIP and GLP-1 are the two major incretin hormones that are discharged by the intestine upon intake of nutrients or glucose). DPP-4’s prevention of GIP and GLP-1 inactivation causes an increase in insulin secretion while suppressing the pancreas from the releasing the hormone glucagon; this, in turn, results to normalization of blood glucose level.

Despite its efficacy, Januvia has been found to cause acute pancreatitis (the sudden inflammation of the pancreas which can result to severe complication or death). In fact, eighty-eight acute pancreatitis cases were reported to the FDA between the 16th of October in 2006 and the 9th of February 2009.

Thus, on September 25, 2009, the FDA required a revision in Januvia’s prescribing information to include information that tells about the reported acute pancreatitis cases associated with the drug. The FDA also asked the drug’s manufacturer to include: reports of necrotizing or hemorrhagic pancreatitis (severe forms of acute pancreatitis) in the prescribing information; the need for healthcare professionals to closely and carefully monitor patients for any sign of pancreatitis development after the drug has been prescribed to them; and, the need to stop use of the drug if pancreatitis is suspected during its use.

An article on the website of Williams Kherkher also speaks of medical findings that prove the high risk of developing pancreatic duct metaplasia, a “pre-cancerous cellular change” that is serious and a potential threat to life, due to use of the drug.

When it involves loss of lives due to the use of drugs, no one has the right to say that the drug’s benefits outweigh the harm. Medication is supposed to provide cure, not more serious illnesses or even death. The manufacturers of harmful drugs, including Merck & Co., have a lot to answer to the individuals (and their families) for the worse illnesses, instead of cure, that these individuals have been subjected to.

2 Comments

  1. 11-20-2014

    Your blog is improperly displaying characters when I use Ubunto with Google Chrome. Just thought you should know!

  2. 11-25-2014

    Do you have a facebook where I can see more posts like this?

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