For the second time in three years pharmaceutical manufacturer Ascend Therapeutics is under fire from the Food and Drug Administration (FDA) regarding it’s only product on the market, Estrogel topical menopausal estrogen gel.
In 2015, the FDA accused Ascend of omitting “important risk information” about Estrogel from a “Zazzle” card distributed to healthcare providers.
Then in August the FDA once again reprimanded the Virginia-based company, this time for publishing false and misleading claims on an Estrogel “sell sheet” given to healthcare providers. A sell sheet, also called a flyer or sales sheet, is a single page document that contains product information and is used for promotional purposes.
An August 15th FDA letter asserted that the company had “misbranded” Estrogel and that selling it in this context was a violation of the Federal Food, Drug and Cosmetics Act. The FDA requested that Ascend immediately stop violating the law and that the company respond to the FDA by August 30.
Estrogel was approved by the FDA in 2004 to treat moderate to severe menopausal vasomotor symptoms such as hot flashes and night sweats, and moderate to severe vulvar and vaginal atrophy (VVA). VVA a condition in which the vulvar and vaginal tissues become dry, brittle and less flexible due to significantly lower estrogen levels in menopausal and postmenopausal women. Symptoms of VVA include burning, itching, inflammation and thinning of the vaginal walls, any or all of which can cause painful intercourse and overall discomfort.
The active ingredient in Estrogel is .06 percent plant-based estradiol, one of three naturally-occurring forms of estrogen, the primary female sex hormone. Two of the FDA’s three complaints in the agency’s August letter pertained to claims Ascend made about the advantageousness of this particular level of estrogen.
The drug should be taken in the lowest possible dose for the shortest amount of time due to potentially serious Estrogel side effects including increased risk of endometrial (uterine) cancer, increased risk of dementia for women 65 and older, and increased risk of heart disease for women in their 70s. Other possible Estrogel side effects – and this is a partial list – include gallbladder disease, weight gain, abdominal pain, hypothyroidism, fluid retention, diarrhea and suspicious pap smears.
On the sell sheet, Ascend claimed that Estogel’s .06 percent estrogen level had been proven to be the lowest effective treatment dose, and secondly, that Estrogel had the lowest effective estrogen dose of any transdermal (applied to the skin) estrogen product on the market.
The FDA countered that Ascend had failed to provide proof that .06 percent estrogen was in fact the lowest effective dose for treating moderate to severe menopausal symptoms, and that other products on the market, including other transdermal products, contained lower amounts of estrogen.
The FDA also accused Ascend of implying that Estrogel had been endorsed by the North American Menopause Society when in fact it has not been.
At publication, Ascend Therapeutics had not responded to MedTruth’s request for comment.
As of publication, the Estrogel informational web page for healthcare providers makes none of the claims that the FDA objected to.
Ascend Therapeutics is one of 18 subsidiaries of Besins Healthcare, a privately-owned pharmaceutical company based in Monaco that sells its products in 100 countries.
According to Ascend, Estrogel is the most-frequently prescribed estrogen product in Europe and Canada.