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Monday, 20-May-2013 21:40 Email | Share | | Bookmark
Serious Health Risks Tied to Victoza Gains FDA Black Box Warning

Victoza, known by its key ingredient liraglutide, is an injectable drug prescribed for the treatment of high blood sugar levels in individuals with type 2 diabetes, medical experts say. A product by Denmark-based pharmaceutical organization Novo Nordisk, it is usually together with other anti-diabetes drugs including thiazolidinediones, sulfonylureas, and metformin.

Novo Nordisk has reportedly acquired approval for Victoza to be distributed in the American consumer market in early 2010. However, prior to this approval, there have been growing questions whether the increasingly popular drug may cause patients to develop thyroid cancer following release study findings suggesting such link to Victoza.

As the FDA announced the approval of Victoza for use in relation with diabetes treatment, the federal agency also made it known that Victoza may have caused thyroid gland tumors to develop in animal models in a study of rats and mice. However, it has yet to be proven whether the drug’s adverse effect may also occur in people. Nevertheless, Victoza received a black box label from the FDA — the sternest alert a medication may carry, highlighting that the medication should not be administered as first-line treatment for diabetes, and should not be prescribed to people made susceptible to medullary thyroid cancer, such as those with a rare genetic condition known as Multiple Endocrine Neoplasia syndrome type 2 and a family history of medullary thyroid cancer.

Certain side effects such as nausea, diarrhea, headache, and pancreatitis (inflammation of the pancreas) have also been linked to Victoza and other diabetes medications such as Byetta.

The FDA has also issued an early communication on March, notifying the public and health care providers of the agency’s intent to closely look into unreleased study results that link Victoza, and other similar diabetes medications to pancreatitis and pre-cancerous cellular changes known as ”pancreatic duct metaplasia”. While the federal agency has yet to reach a conclusion, it may not be too early for patients who may have experienced these alleged adverse effects to embark on a legal course through a Victoza lawsuit, according to legal experts.

Sources:

    drugs.com/victoza.html
    virginiamason.org/PancreaticNecrosis
    accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf
    bloomberg.com/news/2013-03-22/diabetes-drugs-may-cause-damage-to-pancreas-study-finds.html
    fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm198638.htm
    cardiobrief.org/2010/01/25/fda-approves-liraglutide-victoza-for-type-2-diabetes/
    fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343805.htm
    novonordisk.com/include/asp/exe_news_attachment.asp?sAttachmentGUID=b9a7556c-a322-4b44-92c3-a800ddf7aee9


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