The Food and Drug Administration (FDA) has been urged by the public to pull certain drug advertisements due to their misleading nature. The ads in question are for five Type 2 diabetes drugs and the concern is that these ads highlight certain ‘benefits’ of the drugs that have not been approved by the FDA. This is just one of many examples of the growing problem with ‘off-label’ drugs either being promoted for certain unapproved uses or being prescribed to treat something they are not approved for. In this particular case, the FDA was asked to fine the manufacturers of the diabetes drugs in question for violating rules in place that govern off-label marketing. The diabetes drugs and manufacturers that were cited are as follows:
- Farxiya (dapagliflozin)), manufactured by AstraZeneca and Bristol-Myers Squibb
- Jardiance (empagliflozin), manufactured by Boehringer Ingelheim
- Invokana (canagliflozin), manufactured by Janssen Pharmaceuticals
- Victoza (liraglutide), manufactured by Novo Nordisk
- Bydureon (extended-release exenatide), manufactured by Amylin
In the letter to the FDA on April 1st, 2015, the citizen states that “the deliberate placement of the (weight loss) claims in such close proximity to the drugs’ approved indications serves to reinforce this impression”, meaning that the ads make it appear as if the mentioned added benefits are approved and legitimate. In addition to the weight loss claims, ads for the drugs listed above also indicate that blood pressure reduction is touted as a ‘potential benefit’, even though the FDA has not approved the drugs for this purpose. The citizen is encouraging the FDA to issue warning letters to the manufacturers of the drugs in order to get them to pull the ads.
What is The Problem With Off-Label Drugs?
This particular case brings to the light the increasingly serious problem with off-label prescribing, which is the term for when prescription drugs are prescribed for uses other than what the FDA has approved. This is a common practice amongst medical professionals, as it allows doctors to prescribe certain medications that may offer the best possible treatment option for a patient. However, off-label prescribing can also harm patients because when an off-label drug is prescribed, it lacks solid evidence as to its effectiveness and overall safety. There is still incomplete knowledge about the safety and efficacy of many medications commonly used to treat certain conditions in both children and adults. Responsible off-label prescribing requires physicians to evaluate any and all evidence to justify an off-label use, inform patients about the uncertainties associated with off-label prescribing, and do their best to look for additional information and research when adequate evidence is hard to come by. That being said, it is important to recognize the serious repercussions associated with off-label drug use.
If the case mentioned above is any indication, we will likely see an increase in requests for the FDA to monitor patient responses to off-label drug uses and hold the manufacturers of the drugs responsible for false advertisement of certain benefits and uses. If you or a loved one has been injured or become ill due to being prescribed an off-label drug, please contact Wormington & Bollinger. Our knowledgeable team of lawyers will go over your case and determine whether or not you have the right to pursue legal action against the manufacturer of the drug. To set up a consultation with our legal team, give us a call today.