Januvia side effects could include pancreatitis according to FDA
September 25, 2009 by Jay Genkins
Filed under Consumer Alerts, Defective Drugs, FDA
Diabetes treatment Januvia and Janumet ( sitagliptin / metformin ) could be linked to occurrences of acute pancreatitis, According to the FDA.
This is the same problem that sunk sales of Amylin Pharmaceuticals Inc.’s Byetta.
88 cases of acute pancreatitis were reported to the fda in Januvia patients between 10/06 and 02/09.
The agency is working with Merck to include new warning information on the drug’s label.
“It is recommended that health care professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases,” the agency said, in a statement.
Patients who take these drugs are advised by the FDA to discuss this news with thier doctor and advice that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin.
Still, the agency said it is unknown whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of the condition.
“Because acute pancreatitis is associated with considerable morbidity and mortality, and early recognition is important in reducing adverse health outcomes, FDA is recommending revisions to the prescribing information to alert health care professionals to this potentially serious adverse drug event,” the agency said.
What is sitagliptin?
Sitagliptin is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.
Sitagliptin is for people with type 2 diabetes (non-insulin-dependent) diabetes. Sitagliptin is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.
Sitagliptin may also be used for other purposes not listed in this medication guide.
If you or someone you care about has taken a medication and suffered adverse side effects, we urge you to contact our law offices today. You may have actually injected or ingested a defective drug; if so, you could be entitled to monetary compensation for any pain and suffering that resulted from your experiences with the product.
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