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Recent questions over the potential side effects of Invokana, Farxiga and other new-generation diabetes drugs have renewed concerns over the aggressive direct-to-consumer advertisements launched by the drug makers shortly after the medications hit the market.
Invokana (canagliflozin) was the first member of a new class of diabetes drugs introduced in March 2013, known as sodium-glucose-cotransporter-2 (SGLT-2) inhibitors. Farxiga (dapagliflozin) was the second member, introduced in 2014, followed by other similar drugs like Jardiance, Invokamet, Xigduo XR and Glyxambi.
During the short time the new-generation of diabetes drugs have been on the market, they have rapidly grown to become big-sellers, largely driven by direct-to-consumer advertisements where the drug makers encouraged patients to seek out the new diabetes treatments.
Earlier this year, the consumer watchdog group Public Citizen raised serious questions about some of these advertisements, indicating that the pharmaceutical companies were making deceptive and illegal pitches with those ads.
In a letter (PDF) to the FDA’s director of the office of Prescription Drug Promotion on March 31, Public Citizen urged the agency to take action against the diabetes drug commercials, which suggested that the new medications could be used as weight loss products, even though they are not approved for that purpose.
“The ads, which appear in print magazines as well as on the drugs’ official promotional websites, all contain statements describing the alleged weight-reducing properties of the medications,” the letter notes. “However, none of the drugs is approved for weight loss and, despite the presence of disclaimers that the medications are not weight-loss drugs, the implication is clearly that weight loss is an additional potential benefit of the drugs. The deliberate placement of the claims in such close proximity to the drugs’ approved indications serves to reinforce this impression.”
While doctors are allowed to prescribe a drug for any reason they see fit, it is illegal for drug manufacturers to promote their medications for uses not approved by the FDA. This is known as “off-label” marketing.
Concerns over the ads for SGLT-2 inhibitors have taken on a new sense of urgency this summer, after the FDA issued a drug safety communication about the potential risk of ketoacidosis with Invokana, Farxiga and Jardiance.
During the first 15 months that Invokana was on the market, the FDA indicated that more than 20 adverse event reports were received involving individuals using an SGLT2 inhibitor who required emergency room treatment or hospitalization due to diabetic ketoacidosis, ketosis, acidosis or other related conditions that involve a build up of acid in the blood, known as ketones. This can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment and potentially resulting in severe health consequences.
Although diabetic ketoacidosis is commonly associated with type 1 diabetes, it is not normally seen among patients diagnosed with type 2 diabetes, which is the type of diabetes Invokana and the other drugs are approved to treat. Type 2 diabetes is an acquired and curable condition, while type 1 diabetes is usually something someone is born with and persists for life.
In addition to potential ketoacidosis side effects, questions have been raised about a potential link between Invokana and kidney failure, given the mechanism of action that impacts normal kidney function.
The Institute of Safe Medication Practices (ISMP) released a report in May that evaluated adverse event reports submitted to the FDA over the first year Invokana was on the market, identifying several safety signals involving kidney toxicity. The group raised questions about whether the potential Invokana risks may actually outweigh the benefits.
A growing number of lawyers are now reviewing potential Invokana lawsuits, Farxiga lawsuits and Jardiance lawsuits for individuals hospitalized due to ketoacidosis or diagnosed with kidney failure, considering claims for failure to adequately research the new diabetes drug or adequately warn about the potential side effects.
“By inflating the drugs’ perceived benefits, the advertisements dangerously skew the risk-benefit calculations made by physicians and patients in deciding whether to initiate or continue these therapies,” the Public Citizen letter warned nearly two months before the FDA warning. “This is especially likely to occur with a weight-loss claim targeted at overweight and obese Type 2 diabetics struggling with both their disease and weight.”
The letter comes following a year where the FDA approved the highest number of drugs and biologics in its history, 41, while sending out only 10 advertising enforcement letters; the fewest in its history.