FDA Issues Statements on Dangers of Januvia Side Effects
By Robert J. Boumis
The United States Food and Drug Administration has raised a number of concerns about the type-2 diabetes drug Januvia. These concerns include the marketing of the drug, as well as the potential risks for pancreatitis and different types of cancer caused by Januvia side effects.
In a letter dated March 2009, the FDA warned Merck, the manufacturer of Januvia, that some of their marketing tactics did not live up to the FDA’s regulations. The letter mentions that the FDA had reviewed the marketing of several of Merck’s products, including Januvia. It was found that for Januvia, the marketing information omitted various warnings about the health risks associated with this drug. This information is required to market the drug.
Even earlier, in 2008, the FDA reported that they had received reports of adverse drug reactions, specifically that the FDA had received reports of necrotizing pancreatitis in patients taking related drugs. Necrotizing pancreatitis is a serious health crisis, wherein the pancreas become so irritated it begins to rot away within the body.
Januvia continued to stay on the FDA’s radar and the agency released a follow-up Drug Safety Information release in September of 2009. This updated statement specifically mentioned Januvia side effects. This report indicated that their adverse event surveillance tools had received reports of serious forms of pancreatitis, including both necrotizing and hemorrhagic pancreatitis.
The most recent FDA Drug Safety Alert came in March of this year, stating that incretin mimetic drugs (the class of drugs that includes Januvia) had been linked to various forms of pancreatitis, as well as pre-cancerous changes to the cells of the pancreas. In many forms of cancer, physicians can detect changes in cells prior to the onset of full-blown cancer. Several studies have found an increased risk of precancerous changes to the pancreas in patients taking Januvia.
Dozens of product liability lawsuits have been launched against the manufacturers of Januvia and related diabetes treatment drugs like Byetta, Victoza and Janumet. These lawsuits allege that the manufacturers were aware of the serious health risks associated with these diabetes drugs and failed to act on the information in a timely manner.
Plaintiffs in Januvia lawsuits further allege that the manufacturers downplayed the risks of Januvia side effects, preventing patients and their prescribing physicians from having all of the information they needed to make informed medical decisions.
If you – or someone you care – about took Januvia and went on to suffer from serious complications, you probably have a lot to deal with. Major health complications like pancreatitis and various cancers can completely take over a person’s life. But you need to remember that despite whatever else is going on, you still have rights and there are steps that you can take to regain some measure of control over your situation.
You can start by visiting the Type 2 Diabetes Drugs Januvia, Byetta Class Action Lawsuit Investigation. Here, you can enter information about your Januvia side effects. If you have a case, you will be contacted for a free legal consultation regarding your potential Januvia product liability lawsuit.
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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