- 1 Tradjenta and Jentadueto belong to a family of drugs called DPP-4 inhibitors. The drugs are linked to pancreatitis and may also increase the risk of pancreatic cancer.
- 2 How Does Tradjenta Work?
- 3 Tradjenta’s Serious Side Effects
- 4 Pancreatic Cancer Related to DPP-4 Drugs
- 5 Tradjenta’s Common Side Effects
- 6 Tradjenta Manufacturer Information
- 7 Tradjenta Lawsuits
The Food and Drug Administration (FDA) approved Tradjenta in May 2011, after the eight studies submitted by Boehringer Ingelheim showed that Tradjenta consistently improved blood sugar control in nearly 4,000 patients, versus a placebo. Tradjenta’s U.S. sales topped $25 million in the first quarter of 2012 and $33 million in the second quarter.
Although Tradjenta does control blood sugar, it comes with the risk of serious side effects, including pancreatitis. The FDA is investigating reports of additional risks, including pancreatic cancer. These serious side effects are expected to result in lawsuits against Eli Lilly and Boehringer Ingelheim.
How Does Tradjenta Work?
Tradjenta was the third drug to join a class of diabetes drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which are also referred to as gliptins. It is used along with diet and exercise to improve glycemic control in those with type 2 diabetes.
The first DPP-4 inhibitor, Januvia (sitagliptin), was approved in 2006 and is manufactured by Merck & Co. The second drug to be introduced to this class was Onglyza (saxagliptin) in 2009, manufactured by Bristol-Myers and AstraZeneca. Takeda’s Nesina (alogliptin) was approved in early 2013.
DPP-4 inhibitors, like all type 2 diabetes medications, work to lower blood sugar levels. As the body absorbs food, blood sugar rises. This rise in blood sugar prompts the release of incretin hormones, which signal the pancreas to release insulin. Insulin converts the blood sugar into energy.
DPP-4 breaks down incretin, letting the pancreas know that balance has been restored and that no more insulin is needed. DPP-4 inhibitors, like Januvia and Tradjenta, limit the function of DPP-4, to allow an increase in insulin that is needed to control blood sugar levels in people with diabetes.
Tradjenta’s Serious Side Effects
The side effects of Tradjenta are similar to other DPP-4 inhibitors and incretin-based diabetes drugs like Byetta, because they all act on the same process. Side effects can range from allergic reactions, to mild symptoms like a headache or runny nose, to life-threatening conditions like the inflammation of the pancreas.
Like many diabetes medications, Tradjenta can cause hypoglycemia, or low blood sugar. If Tradjenta is prescribed alongside another diabetes drug, doctors will likely lower its dosage to prevent hypoglycemia.
|Signs of hypoglycemia can include:|
|Light-headedness or dizziness||Confusion|
|Headache||Rapid heart rate|
The prescribing information that comes with Tradjenta warns of the risk of pancreatitis, which is a painful inflammation of the pancreas that causes the body’s digestive enzymes to attack the pancreas. It can lead to tissue damage, cyst formation, bleeding and infection that can spread to other organs. Pancreatitis can also lead to pancreatic cancer.
Necrotizing pancreatitis is a more severe and potentially deadly form in which the body actually begins to digest the pancreas. When the onset is sudden, it is called acute pancreatitis, and it can be fatal.
Patients taking Tradjenta should alert their physician if they experience side effects like nausea, vomiting, fever, rapid heart rate, abdominal pain or low back pain that may worsen while bending forward or eating.
Pancreatic Cancer Related to DPP-4 Drugs
People taking Januvia and Byetta more than double their risk of developing pancreatic cancer. The risk increases the longer the drugs are used. Because Januvia, Byetta and Tradjenta all affect the levels of incretin in the body, patients and doctors are concerned that Tradjenta carries the same risk.
Pancreatic cancer is very hard to detect, and is frequently diagnosed in late stages. The average rate of survival is less than 2 years, according to the American Cancer Society.
In March 2013, the FDA issued a safety warning regarding incretin-based diabetes drugs, listing Januvia, Byetta, Tradjenta and Jentadueto among those being investigated. Research findings suggest these medications increase the risk of developing precancerous cells in the pancreas.
The FDA does not have conclusive evidence to tie these drugs to the increased risk of pancreatic cancer, but continues to investigate the link. The FDA will offer its final recommendations on these drugs after participating in the National Cancer Institute’s Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013.
Tradjenta’s Common Side Effects
The most commonly reported side effects of Tradjenta are similar to the common cold or respiratory infection and include cough, stuffy or runny nose, sore throat and headache. Patients have also reported muscle or joint pain, as well as back pain.
Tradjenta alone is not associated with weight gain, but weight gain has been reported when Tradjenta is taken with other diabetes drugs like Amaryl, Glucotrol and other sulfonylureas.
Tradjenta Manufacturer Information
The launch of Tradjenta marked the beginning of a strategic global alliance formed by Boehringer Ingelheim and Eli Lilly to produce and distribute new diabetes treatment options. Diabetes drugs account for at least a quarter of all pharmaceutical sales in the United States.
The alliance plans to develop and commercialize diabetes treatments in addition to Tradjenta, including an SGLT-2 blocker (BI-10773) and a basal insulin analogue. Under the terms of the agreement, Eli Lilly paid Boehringer Ingelheim nearly $445 million up front to kick off the collaboration. The companies will share costs and revenues from their joint products.
Eli Lilly and Boehringer Ingelheim also could end up sharing the costs of Tradjenta lawsuits. Because Tradjenta and Januvia are both DPP-4 inhibitors, industry watchdogs are keeping an eye on legal action related to Tradjenta. If reports of pancreatitis or pancreatic cancer are linked to Tradjenta, like they have been to Januvia, lawsuits could follow.
In lawsuits pending against Januvia manufacturer Merck, plaintiffs claim the company concealed the risks of serious side effects and endangered consumers.