If you have purchased and used Latisse TM (for eyelash growth) on or before September 17, 2009, you may be entitled to compensation. Please contact our office by completing the Latisse Client Questionnaire, and calling before the deadline toll-free: 888-350-3931.
This notice applies to all residents of Arkansas, Connecticut, Florida, Kansas, Missouri, New Jersey, New Mexico, South Carolina, New York, Ohio, Vermont and Wisconsin. If you live in one of these states, you may be eligible for compensation if you purchased and used Latisse TM on or before September 17, 2009.
Please click here to contact our law firm immediately for a free consultation. The law firm of Craft Hughes Law, P.C. is actively reviewing potential Latisse TM eyelash cases of deceptive advertising against Allergan, Inc. Please click here to contact an attorney; or call us toll-free at 888-350-3931 and ask to speak to attorney W. Craft Hughes.
September 10, 2009 - The U.S. Food and Drug Administration ("FDA") has told Allergan, Inc. that it has made misleading claims and downplayed potential side effects about its drug Latisse TM, used to lengthen and darken eyelashes. The complete FDA Letter sent on September 10, 2009 can be viewed by clicking here.
One of Latisse Brochure's can be viewed by clicking here.
Latisse TM (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness, and darkness.
In a letter sent to the company Sept. 10 and released Wednesday, the FDA told Allergan to immediately stop disseminating the information about Latisse TM and to respond to the agency on or before September 24, 2009. Read the complete article by clicking here.
Heather Katt, a representative of California-based Allergan, said Thursday that the company was working closely with the FDA to address all its concerns.
The FDA said in the letter that it reviewed the "frequently asked questions" and "about safety" pages of the Latisse TM Web site as part of its routine monitoring and surveillance program. The agency found some of the materials to be misleading because the Web site omitted and minimized risks associated with Latisse TM.
Specifically, the letter said, the Website omits the risk of bacterial keratitis from contamination of Latisse TM or the applicators and the risk of the use of the product for people using contact lenses. A page of the Website also fails to communicate the potential for excessive hair growth outside the treatment area, the letter said.
"In addition, the Web pages do not mention the potential for disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and the direction of eyelash growth," the FDA letter said.
The FDA also said claims made on the Web site minimize the risks associated with Latisse TM because the information misleadingly suggests that eye itching and redness are not associated with allergic reactions related to the Latisse TM treatment.
"Allergic conjunctivitis is an adverse reaction reported with bimatoprost ophthalmic solution, which is the same active ingredient that is used in Latisse TM," the letter said.
"Moreover, eye redness and itching, which are frequent symptoms of an allergic reaction, usually resolve only after discontinuation of the drug. These claims are also concerning because patients are highly unlikely to be able to differentiate between eye redness associated with conjunctival hyperemia, allergic reaction, or inflammation without the advice of a health care provider."
The FDA also said the Web site failed to mention that the use of Latisse TM is associated with side effects in answer to the question, "Is Latisse TM safe?"
Instead, the answer listed implies that Latisse TM is especially safe because the FDA has verified the identity, potency, purity and stability of the ingredients in Latisse TM. "This presentation thus significantly minimizes the risks of the drug," the letter said.
The FDA also took issue with a launch display time line for Latisse TM, which presents an exhibit of "evolution of lash enhancers." The agency said the display failed to present risk information with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.
Katt said Thursday that Allergan was no longer using the time line.
Allergan announced in December 2008 that the FDA had approved Latisse TM as a novel treatment for hypotrichosis of the eyelashes. The company says the once-daily prescription treatment will result in longer, fuller and darker eyelashes in as little as eight weeks, with full results in 16 weeks.
Contact an Attorney Now
If you have purchased and used Latisse TM on or before September 17, 2009, you may be entitled to compensation. Please contact our office by completing the Latisse Client Questionnaire, and calling before the deadline toll-free: 888-350-3931.
This notice applies to all residents of Arkansas, Connecticut, Florida, Kansas, Missouri, New Jersey, New Mexico, South Carolina, New York, Ohio, Vermont and Wisconsin. If you live in one of these states, you may be eligible for compensation if you purchased and used Latisse TM on or before September 17, 2009.
Please click here to contact our law firm immediately for a free consultation. The law firm of Craft Hughes Law, P.C. is actively reviewing potential Latisse TM eyelash cases of deceptive advertising against Allergan, Inc. Please click here to contact an attorney; or call us toll-free at 1-888-350-3931 and ask to speak to attorney W. Craft Hughes.
