FDA Warns of Risks With Liraglutide
The FDA has issued a warning about the risks of thyroid cancer and pancreatitis associated with the diabetes drug liraglutide (Victoza).
The agency issued the safety alert and directed drugmaker Novo Nordisk to send out a "Dear healthcare professional" letter after determining that some primary care providers were not fully aware of the serious risks.
The drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Liraglutide causes thyroid C-cell tumors in rats and mice exposed to levels of the drug similar to those used clinically. The risk rises with dose and duration of treatment.
Whether the same is true for humans has not been ruled out by clinical trials, which have shown a handful of papillary thyroid carcinomas.
The FDA decided to approve the glucagon-like peptide-1 (GLP-1) analogue early last year, despite the split vote of its advisory committee over the thyroid cancer risk, but recommended against first-line use for type 2 diabetes until more evidence is available.
While the agency did not push for routine monitoring of elevated serum calcitonin or of thyroid nodules, finding either should prompt primary care providers to refer patients to an endocrinologist for further evaluation, the safety advisory noted.
Clinical trials have shown more cases of pancreatitis with liraglutide than with other diabetes drugs, so the FDA recommended patient monitoring after starting liraglutide or raising the dosage, for symptoms such as persistent severe abdominal pain. This pain can sometimes radiate to the back and is accompanied by vomiting.
Liraglutide should be immediately stopped if pancreatitis is suspected and not restarted if the disease is confirmed.
The FDA urged a cautious approach in patients with a history of pancreatitis. The agency also highlighted the contraindication for liraglutide in patients with a personal or family history of medullary thyroid cancer or a personal history of multiple endocrine neoplasia syndrome type 2.
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An acute abdomen is the sudden onset of severe abdominal symptoms, including pain, usually due to a major problem with one of the organs in the abdomen such as the appendix, gall bladder, intestine, and so on. It may be caused by inflammation of the organs, rupture, perforation or any other pathology. An acute abdomen can proceed to become a medical emergency with potentially life-threatening consequences unless correctly diagnosed and treated immediately. Surgical intervention often becomes necessary.
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