Janumet and Januvia Side Effects FAQs

Q: What are Janumet and Januvia?

Janumet and Januvia are type 2 diabetes medications used to control high blood sugar levels. Normally, when a healthy individual eats a meal, the pancreas begins to release a hormone called "insulin." Insulin helps the body transfer sugar from the bloodstream to other parts of the body where it's converted into energy. However, patients with type 2 diabetes have a difficult time producing insulin. As a result, when they eat, some of the sugar stays in the bloodstream, causing their blood sugar levels to rise.

Janumet and Januvia are designed to lower blood sugar levels by increasing insulin production in the pancreas. In essence, they mimic the function of the naturally-occurring hormone "incretin" which stimulates insulin release. Accordingly, Janument and Januvia are classified as incretin mimetic drugs. In addition, these two medications decrease the natural sugar production that takes place in the liver.

Q: What are the similarities and differences between Janumet and Januvia?

Januvia is a brand name version of the generic drug sitagliptin. Januvia received approval from the U.S. Food and Drug Administration (FDA) in 2006. Janumet, on the other hand, is considered a variation of Januvia. Composed of the generic drugs sitagliptin and metformin, Janumet received FDA approval in 2007. Janumet and Januvia, both manufactured by Merck & Co., have grown very popular among type 2 diabetes patients, attaining combined global sales of $5.7 billion in 2012 alone.

A key distinction between the two drugs is that Janumet carries a black box warning - the FDA's most serious type of warning - because it may cause lactic acidosis, an illness that can cause respiratory and abdominal distress. Since Janumet contains metformin, metformin can accumulate in the blood causing lactic acid to build up in the bloodstream.

Q: What are common Janumet and Januvia side effects?

Common complications associated with Janumet and Januvia include:

• Diarrhea
• Headaches/migraines
• Sore throat
• Muscle aches and cramps
• Breathing difficulties
• Runny or stuffy nose

Q: What are serious complications associated with Janumet and Januvia?

Pancreatitis

In 2009, the FDA announced that it was revising the prescribing information for sitagliptin products such as Janument and Januvia to include reports of acute pancreatitis in patients taking sitagliptin. Acute pancreatitis is inflammation in the pancreas for a short period of time. The severity can range from mild discomfort to life threatening.

Pancreatitis can create conditions where the heart, kidneys, and lungs could be vulnerable to harm. The grave nature of the situation led the FDA to advise health care professionals to carefully monitor for signs of pancreatitis after initial dosages or increases in dosage of sitagliptin. The FDA also advised health care professionals to discontinue prescribing sitagliptin for patients if pancreatitis is suspected.

Pancreatic Cancer

In 2013, the FDA announced it would be investigating whether incretin mimetic drugs such as Janumet and Januvia increase the risk for pancreatitis and pancreatic cancer. The investigation was sparked by reports from academic researchers who took pancreatic tissue samples from deceased patients who had died of unspecified causes. Some of these tissue samples linked incretin mimetics to pancreatitis and pancreatic cancer. Subsequently, the FDA requested the researchers' methodology and tissue samples for independent verification.

As of May 2014, the FDA has not yet reached any conclusions on incretin mimetics' alleged link to pancreatic cancer. Until any new developments, patients are advised to continue taking incretin mimetics.

Q: What are the benefits of filing a lawsuit?

A patient who has been injured by Janumet or Januvia side effects may turn to the legal system for help. These types of cases are based on product liability laws. Under product liability law, manufacturers and sellers have a duty to ensure that their products are free from any unreasonable dangers or defects. In a successful product liability suit, the plaintiff can recover compensation for medical expenses, lost wages, and pain and suffering.

If you're considering a lawsuit against Merck & Co. for Janumet or Januvia use, it would be wise to consult with a products liability attorney to discuss your legal options. You should note that time is of the essence in these cases because some states have statutes of limitations (time limits) for product liability claims.