Public Citizen Shines a Light on Off-Label Promotion of Diabetes Drugs

The ad looks trustworthy. It contains bright colors and an attractive photograph, and it promises that this drug can help you lose weight as well as control your diabetes. It even lists side effects, though you may not be able to read them in the fine print. Based on everything the ad has told you, you consider asking your doctor to prescribe the drug to help you lose weight. But despite an obligatory disclaimer — also in small print — you probably won’t realize that this drug isn’t even approved for weight loss.

In March, Public Citizen urged the Food and Drug Administration (FDA) to stop the dissemination of several advertisements for diabetes medications that promote the drugs for weight loss and blood pressure reduction. The drugs have never been approved to treat these conditions, qualifying the ads as illegal “off-label” marketing.[1]

The direct-to-consumer pharmaceutical ads appear in magazines, on television and online, and they promote five different diabetes medications: canagliflozin (INVOKANA), dapagliflozin (FARXIGA), empagliflozin (JARDIANCE), extended-release exenatide (BYDUREON) and liraglutide (VICTOZA). The ads all contain statements describing alleged weight-reducing properties of the medications. In the case of canagliflozin and dapagliflozin, blood pressure reduction also is touted as a potential benefit.

Dangerous side effects

By inflating the drugs’ perceived benefits, the ads likely influence physicians and patients — particularly overweight and obese Type 2 diabetics — to use drugs that promise to help them control both their disease and their weight. This is especially concerning when the drugs in question all carry serious risks that may outweigh the sole, limited benefit of helping control patients’ blood sugar.

The drugs’ adverse effects include urinary tract infections and yeast infections (canagliflozin, dapagliflozin and empagliflozin), bladder cancer (dapagliflozin), pancreatitis and thyroid tumors (extended-release exenatide and liraglutide), and kidney impairment (all).[2] Canagliflozin, dapagliflozin and empagliflozin also can cause dangerously low blood pressure, making the claim of blood pressure reduction as a potential benefit of the first two drugs especially egregious.

FDA enforcement lacking

The off-label ads have been released during a time when the FDA’s enforcement of pharmaceutical marketing has fallen dramatically from previous years — at least as measured by the number of letters citing drug companies for ads that violate agency regulations (known as “warning” and “untitled” letters). From 1997 to 2001, the earliest five-year period for which data are publicly available, the agency sent an average of 111 such letters per year, while an average of only 29 letters per year were sent during the most recent five-year period, 2010 through 2014.[3]

The FDA’s dismal record on issuing warning and untitled letters to companies mirrors the agency’s reluctance to issue fines. Despite having been granted the authority in 2007 to issue civil monetary penalties to drug companies for direct-to-consumer ads that violate the law, the agency has yet to use this authority a single time.[4]

This inaction is not for a lack of offending ads. Tens of thousands of direct-to-consumer and physician-targeted pharmaceutical ads are submitted by drug companies to the FDA every year.[5] According to a 2014 study of a random sample of 84 television ads released between 2008 and 2010, 55 percent of the “most emphasized” statements in each ad were “potentially misleading,” and 2 percent were “objectively false.”[6]

What You Can Do

We recommend that you not use any of the five diabetes drugs mentioned in this article for any purpose, including diabetes as well as weight loss. For more information on diabetes drugs, please see “Type 2 Diabetes: A Guide to Prevention and Treatment” in the May 2014 issue of Worst Pills, Best Pills News or information on WorstPills.org. We also have published Worst Pills, Best Pills News articles on dapagliflozin (September 2014 issue), canagliflozin (February 2014 issue) and liraglutide (April and July 2011 issues).

The marketing examples identified in this article highlight the need for a great deal of skepticism when reading or viewing pharmaceutical ads. If you have questions or concerns about information presented in a pharmaceutical ad for a drug you are taking, consult your doctor. You also can read the actual FDA-approved labels of all drugs on the Drugs@FDA website (www.accessdata.fda.gov/scripts/cder/drugsatfda/) or on the National Institutes of Health’s DailyMed website (www.dailymed.nlm.nih.gov/dailymed/index.cfm).

References

[1] Public Citizen. Letter to FDA on the off-label promotion of several diabetes drugs. March 31, 2015. http://www.citizen.org/documents/2250.pdf. Accessed April 21, 2015.

[2] Food and Drug Administration. Most recent available FDA-approved labels (Farxiga 08/14; Jardiance 08/14; Invokana 03/15; Victoza 04/13; Bydureon 05/14) downloaded from: FDA-Approved Drug Products. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed March 10, 2015.

[3] Public Citizen. Letter to FDA on the off-label promotion of several diabetes drugs. March 31, 2015. http://www.citizen.org/documents/2250.pdf. Accessed April 21, 2015.

[4] Personal communication, on January 27, 2015, with Jean-Ah Kang of the Food and Drug Administration’s Office of Prescription Drug Promotion.

[5] Government Accountability Office. FDA’s Oversight of the Promotion of Drugs for Off-Label Uses. July 2008. http://www.gao.gov/assets/280/278832.pdf. Accessed May 6, 2015.

[6] Faerber AE, Kreling DH. Content analysis of false and misleading claims in television advertising for prescription and nonprescription drugs. Journal of General Internal Medicine. 2014;29(1):110-118.