Published on October 31st, 20190
Matthews and Associates
TINA.org obtained the letters through a Freedom of Information Act request. One of the firms was Matthews and Associates.
Here’s what the Matthews and Associates TV ad cited in the letter said:
Amputations, gangrene of the limbs or genitals and ketoacidosis have been associated with the use of Invokana and Invokamet, medications used to treat Type 2 diabetes. … The FDA announced that final results from two large clinical trials showed patients using SGLT2 inhibitors, including Invokana and Invokamet, were about twice as likely to develop gangrene requiring leg and foot amputations, mostly affecting the toes. The FDA also warned that patients, both men and women, who use Invokana, Invokamet, and other SGLT2 inhibitors to treat Type 2 diabetes have an increased risk of developing gangrene of the genitals.
And what the FTC said:
We note that the FDA describes gangrene of the genital area as a rare side effect. Accordingly, the implication that these products pose a substantial risk of gangrene of the genital area appears to be false. In addition, this ad may convey to a significant number of viewers that taking SGLT2 inhibitors poses a substantial risk of toe, leg, and foot amputations and that the risks from taking these medicines outweigh their benefits. Unless you have competent and reliable scientific evidence to support such claims, you should not make them
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