The consumer advocacy group, Public Citizen, has called on the U.S. Food and Drug Administration (FDA) to withdraw a diabetes drug because of concerns of heightened pancreatitis, kidney failure, and thyroid cancer risks.
Public Citizen says that in a crowded field of similar diabetes drugs, the drug Victoza, which is manufactured by the Danish pharmaceutical manufacturer Novo Nordisk, has risks that far outweigh its benefits.
To back up its claim, the advocacy group cited that reports of pancreatitis were 3.7-times higher in patients who had used Victoza as opposed to other similar diabetes drugs. Public Citizen also claims that medical reviewers for the FDA noted that the drug had caused thyroid tumors in rats and mice. Because lab outcomes with rodents cannot conclusively prove reciprocal outcomes in humans, the FDA warning label for the drug currently states it is “unknown whether Victoza will cause” thyroid cancer in humans.
According to the Huffington Post, Novo Nordisk denies the allegations, claiming that it has worked closely with the FDA and that the agency approved the drug based on studies involving over 4,000 patients.
Public Citizen cited internal FDA documents in which three of the medical reviewers were against the 2010 approval of the drug. One of the reviewers wrote, “The need for new therapies for Type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”
A Florida dangerous product injury lawyer at Farah & Farah will be keeping tabs on the risks associated with Victoza and other potentially harmful drugs on the market. If you believe you have been injured due to an adverse drug reaction, you might be eligible for compensation. Call us at (800) 533-3555 for a free and confidential assessment of your case.