Undisclosed Drug Side Effects? Type 2 Diabetes Drug, Byetta Linked to Increased Cancer Risks

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Research has revealed that Byetta (exenatide), which is prescribed for the treatment of Type 2 diabetes, has been associated with increased risk reports for pancreatic and thyroid cancers.

Byetta, a twice-daily injection, was approved in 2005 for use with other diabetes treatments; the drug was later approved as a stand-alone Type 2 diabetes therapy. In a class of drugs called glucagon-like peptide-1 (GLP-1), Byetta increase some natural substances that lower raised blood sugar levels. Typically, diabetics either do not efficiently utilize insulin or have abnormally low insulin levels.

Studies have linked Byetta to some significant adverse reactions. Up until now those links have been specifically with pancreatitis. Of note, pancreatitis is a known risk factor for pancreatic cancer. Other serious side effects have been linked to Type 2 diabetes drugs like Byetta such as low blood sugar; anaphylaxis and other allergic reactions such as hives, rash, swelling of face, lips, tongue, and/or throat; and death.

Byetta’s pancreatic cancer risks are being seen more-and-more in recent research. In fact, a study on Byetta and drugs like it, conducted by researchers at the University of California, Los Angeles found that Byetta patients experienced a nearly three-fold risk of developing pancreatic cancer. Evidence also suggests an increased incidence of thyroid cancer among patients taking Byetta.

Most recently, a March 14 Drug Safety Communication issued by the U.S. Food and Drug Administration (FDA) stated that pancreatic tissue samples taken as part of a study revealed inflammation and cellular changes that are often precursors to cancer. The samples came from a small group of diabetes patients who had taken the new medications, said the Associated Press (AP). The samples were secured post-mortem and the deaths were due to an array of causes.

Although it has issued alerts about pancreatic risks associated Byetta and drugs like it, the FDA has not advised consumers about the pre-cancerous cell changes seen with these drugs, said the AP.

Byetta Whistleblower Protection Under the False Claims Act

In recent years, many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects.

The False Claims Act allows for private persons to file lawsuits providing the government with information about wrongdoing. If a person is found to have knowingly submitted or caused others to submit false or fraudulent claims to the U.S., the government can recover treble damages and $5,500-$11,000 per statute violation. Should the government successfully resolve or litigate its claims, the person who brought the whistleblower complaint may receive 15-25 percent of the recovered amount. If the government declines to join the case, the lawsuit may proceed privately, with the whistleblower entitled to a 25-30 percent recovery reward.

This is important given that, Amylin Pharmaceuticals, the maker of Byetta, was criticized for allegedly hiding a study that revealed serious heart risks associated with Byetta. In fact, the FDA alleged that Amylin concealed the Byetta heart study from the agency and tried to keep the agency from accessing key study data when the FDA learned of its existence. Byetta and Bydureon (exenatide) are both made with the same active ingredient.

Last year, the division director of the FDA unit responsible for the regulation of kidney drugs wrote that approval of Amylin’s longer-acting Bydureon was a “long and complicated process,” in part because of “Amylin’s withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon.” The memo stated that the agency only learned of the disturbing cardiac findings associated with Byetta when Canadian regulators alerted the FDA. The FDA asked that data be included in Amylin’s Bydureon resubmission. When the application was resubmitted, the data were missing, and were, instead, submitted separately and as an addendum to the original Byetta regulatory file.

The FDA eventually did approve Bydureon; however, noted TheStreet, Amylin hid the truth about the Byetta heart study from its investors and FDA records indicate that Amylin neglected to disclose that the Byetta heart-safety study played a significant role in the FDA’s rejection of the drug.