OPDP Issues Second Untitled Letter of 2019

Regulatory NewsRegulatory News | 30 May 2019 | By

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week issued its second untitled letter of the year to California drugmaker Vivus because of claims made on the company’s website about its weight-loss drug Qsymia (phentermine and topiramate).
 
With just two enforcement letters sent so far in 2019, FDA is continuing a years-long trend of declining enforcement action over prescription drug promotion. In 2017 OPDP issued a record low of three warning letters and one untitled letter and in 2018 the office issued two warning letters and five untitled letters.
 
Untitled Letter
 
According to the untitled letter, Vivus made unsubstantiated claims about Qsymia’s efficacy and downplayed the drug’s risks on its website.
 
FDA emphasizes that the misrepresentations on the website are “especially concerning from a public health perspective” and stresses that “consumers and patients who seek assistance with their weight-loss goals should not be misled regarding the actual benefits, serious risks, and necessary nutritional and lifestyle modifications associated with the use of a weight management prescription drug.”
 
Qsymia is indicated for chronic weight management in combination with a reduced-calorie diet and physical exercise.
 
Qsymia is also associated with a number of serious adverse events and is contraindicated in patients with glaucoma, hyperthyroidism and who are hypersensitive to sympathomimetic amines as well as in pregnant women and in patients who have recently taken monoamine oxidase inhibitors.
 
Some of the warnings and precautions for the drug include a risk for fetal toxicity, increased heart rate, suicidal behavior and ideation, cognitive impairment and metabolic acidosis. More common side effects include paresthesia, dizziness, dysgeusia, insomnia, constipation and dry mouth.
 
At issue are statements made by Vivus on its website that suggest Qsymia can help patients lose weight “3 times faster than diet and exercise alone” and other statements that FDA says do not adequately convey the fact that Qsymia is indicated as an adjunct to diet and exercise.
 
FDA says it is “not aware of data to support” the claim that Qsymia can help patients lose weight three times faster than diet and exercise alone, and says the studies cited by the company on the webpage “do not support the rate of weight loss since they describe the amount of weight loss at specific points of time.”
 
The agency also says that the website did not include necessary information about Qsymia’s role as an adjunct to diet and exercise. “We note that the webpage contains illustrations showing an exercise bike, a bag of groceries, and a capsule. However, these are not adequate to convey to the viewer that both exercise and diet are necessary in achieving the benefits (weight management) of Qsymia,” FDA writes.
 
Additionally, FDA says the data included on the webpage was cherry picked to present a “more favorable” representation of the amount of weight loss and reduction in weight circumference demonstrated by the clinical studies conducted for the drug.
 
“By failing to account for an individual’s baseline weight and waist circumference and omitting this context on the webpage, this presentation misleadingly implies that all patients, no matter their baseline weight or waist circumference, should expect to achieve similar results to the absolute amounts presented on the webpage,” FDA writes.
 
Lastly, FDA says the company failed to prominently display information regarding the drug’s contraindications, warnings, precautions and adverse reactions by relegating that information to the bottom of the site past the information on the drug’s benefits.
 
Letter, Promotional Material

 

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