FDA Warns ASCEND Therapeutics
The FDA’s Office of Prescription Drug Promotion has warned Herndon, Va., drugmaker ASCEND Therapeutics US for distributing promotional cards about its EstroGel product that omit important risk information.
The agency says the cards are misleading because they include efficacy claims for EstroGel — a topical estradiol gel used to treat vasomotor symptoms caused by menopause — without mentioning that using estrogen therapies increases the risk of endometrial cancer, cardiovascular disorders, breast cancer, stroke, pulmonary embolism and dementia. Those concerns, along with an extensive list of contraindications, are highlighted in a boxed warning on EstroGel’s labeling.
While the cards mention an increased risk of “certain cancers, cardiovascular disorders and dementia,” specific information and contraindications are excluded, the June 23 warning letter says.
Further, the statements “please visit www.estrogel.com for additional information” and “see full prescribing information and boxed warning,” included on the cards, aren’t acceptable substitutes for the risk information and misleadingly suggest that EstroGel is safer than it is, the FDA says.
OPDP told Ascend to stop distributing the cards and any other promotional materials that contain similar omissions.
ASCEND did not respond to a request for comment by press time. Read the warning letter at www.fdanews.com/07-13-15-ASCENDWarning.pdf. The promotional card can be viewed at www.fdanews.com/07-13-15-card.pdf. — Kellen Owings