FDA Receives Reports of Januvia Cancer
By Robert J. Boumis
Once a drug is on the market, the United States Food and Drug Administration keeps tabs on it through a process called “postmarket surveillance.” This process can often uncover new side effects not found in original trials. For example, postmarket surveillance of the diabetes drug Januvia has revealed a possible link between the drug and various forms of cancer.
In the process of approving a drug, pharmaceutical companies perform human trials. However, while companies spend millions, if not billions, on this process, they cannot test everyone. Sometime, the testing groups are simply not big enough or long enough to expose every possible side effect of a drug. For this reason the FDA conducts postmarket surveillance.
In postmarket surveillance, the FDA has a hotline that allows patients and physicians to report adverse reactions to drugs. If a patient takes a drug and has a negative reaction, they are encouraged to report any problems. The FDA also looks to peer-reviewed medical research for reported adverse actions.
In the case of Januvia, the trade name of sitagliptin, the FDA has received reports of pancreatic cancer and thyroid cancer in patients who used the drug. Additionally, a study by the University of California Los Angeles (UCLA) was recently published in March issue of Diabetes, a medical journal. This study found that patients taking Januvia and related medications had a much higher risk of developing serious pre-cancerous changes to their pancreatic tissue. Pre-cancerous changes indicate that cells have changed from their normal, healthy state, and have begun to resemble cancer cells. Patients with these pre-cancerous changes often have a much higher risk of developing cancer than a patient without them.
Based on the evidence from postmarket surveillance, the FDA may require changes to the labeling and packaging of Januvia and similar diabetes drugs. These changes may include adding new warnings based on the risk of pancreatic cancer.
A class action lawsuit investigation has been launched to find patients who took Januvia and went on to develop serious health problems like pancreatitis, pancreatic cancer or thyroid cancer. Lawsuits of this nature allege that the dangers associated with Januvia and similar drugs have been known for years.
These drug injury lawsuits further allege that the manufacturers of these drugs downplayed these risks, preventing patients and their prescribing physicians from having all of the information they needed to make informed decisions regarding their medical care. Plaintiffs are seeking damages for health problems sustained after taking Januvia or related drugs.
If you or someone you know took Januvia, then went on to develop serious complications like pancreatic cancer, you may feel overwhelmed. You might not know what steps to take next. But you do have rights. And there are steps that you can take to get your life back on track. You can start by visiting the Type 2 Diabetes Drugs Januvia, Byetta Class Action Lawsuit Investigation. Here, you can enter your information. Your information will be reviewed by a legal expert who specializes in this type of situation. This initial consultation is free of charge. From here, you can receive guidance on the next steps to take in your specific situation.
Updated May 28th, 2013
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