Consumer Drug Safety

FDA Inquiry About Diabetes Drug Saxagliptin Starts

Chris Seeger TestosteroneIt was announced in February that the United States Food and Drug Administration, better known as the FDA, will begin investigation into alleged links between the diabetes drug Saxagliptin and elevated chances of heart attack amongst users.

What spurred the FDA inquiry about Saxagliptin was an article published by the New England Journal of Medicine in September of last year. In the article, it was actually said that the study associated with the publication found no link effect on heart attack or stroke risk for patients who used Saxagliptin.  Comments from a prominent New England Doctor, made in a press release shortly after the article was published, however, suggested that all risks hadn’t been assessed.

Doctor Says More Studies Are Needed

The doctor-Dr. Eugene Braunwald, was chair of the study. He works at Boston’s prestigious Brigham and Women’s Hospital and also teaches at Harvard University Medical School, and stated in a press release that the data “deserves further study” because his team did observe a higher heart failure hospitalization rate for Saxagliptin users which made the issue “worthy” of additional study.

The original study included Type 2 Diabetes patients from 26 different countries-16,500 people in all, who were treated with Saxagliptin. The study was funded with money from Saxagliptin’s manufacturers-pharmaceutical giants Bristol Myers Squibb and AstraZeneca. As more studies ensue, and as the FDA inquiry about Saxagliptin gets under way, the agency has not advised patients to stop using the drug, whose users have seen success in treating their diabetic conditions. The FDA does, however, advise users to consult their doctors individually.

FDA: A Broader Inquiry In Underway

The FDA’s inquiry about Saxagliptin is part of a broader investigation into the side effects of diabetes drugs, the agency says. The FDA is also looking at links between heart attacks and the older diabetes drug Avandia, which was approved in 1999.

In 2010, a US Senate report signed by Senator Max Baucus and Senator Chuck Grassley said the drug’s maker, GlaxoSmithKilne “abused patients’ trust” and concluded that the drug raised heart attack risk as part of 334 pages of information the document contained, CNN reported. Medical News Today said last year that a Duke University study showed the drug didn’t raise heart attack risk more than other drugs it was compared to, but Medical News Today didn’t state there was no risk in using Avandia. FDA’s inquiry about Saxagliptin will likely raise the same discussion again. The agency has remained very cautious about diabetes drugs ever since the Senate report on Avandia.

Saxogliptin, which is marketed as Onglyza and Kombiglyze XR, is used to help patients gain better control of their blood sugar levels and in some cases, enables them to reduce the need for more-expensive-and-more-complicated insulin therapy.  The FDA’s inquiry about Saxagliptin will continue as its detailed investigation does.

In the meantime, patients are growing more confused about what to do when it comes to treating their diabetes. The United States Center For Disease Control, or CDC, says that approximately 26 million Americans currently have Type 2 Diabetes. That means that nearly a tenth of the US population is looking for answers about their diabetes care, not to mention all those who care about them and for them.

Some will wonder if they should stop taking their meds. Others will wonder if they should switch to another drug that hasn’t gotten bad publicity amidst the mixed opinions of the medical community. Heart disease is also a well-known killer in the United States, and doctors would prefer not to trade one epidemic for another. Says Dr. Tara Narula of New York City’s Lenox Hill Hospital Cardiac care unit, there is “tremendous confusion” among her patients.

Show Sources
  1. New England Journal of Medicine http://www.nejm.org/doi/full/10.1056/NEJMoa1307684
  2. CNN "Senate report links diabetes drug Avandia to heart attacks" http://www.cnn.com/2010/HEALTH/02/20/avandia.study/
  3. MNT "Avandia (Rosiglitazone) Does Not Raise Heart Attack Risk, Study" June 7 2013 http://www.medicalnewstoday.com/articles/261666.php