Allergan Bats Its Lashes At Glaucoma Drug
4 CommentsBy Ed Silverman // November 19th, 2007 // 7:15 am
The company that brought us Botox - and gave new meaning to ironing out the wrinkles - is tinkering with its own Lumigan glaucoma med because a side effect is eyelash growth. In fact, this unintended consequence has set off a race among cosmetics companies to create new eyelash treatments that contain either bimatoprost - the active ingredient in Lumigan - or other so-called prostaglandins found in glaucoma drugs, The Wall Street Journal reports.
The eyelash products look like mascara tubes and have a brush or tip for applying the product along the base of the lashes, and typically sell for $140 to $160 in spas and a doc’s office. At the same time, some docs are writing Lumigan off-label scripts for their cosmetic patients. But the companies pushing into this arena are already facing two big fights: one with each other, the other with the FDA, the paper writes.
Last week, the agency raided a San Jose warehouse belonging to Age Intervention Eyelash and seized thousands of tubes containing what was called an “unapproved and misbranded drug.” And earlier this month, Allergan filed a patent-infringement suit against several eyelash companies that it says use a prostaglandin in their products.
Lorrie Klein, a cosmetic dermatologist in Laguna Niguel, Calif., tells the Journal she started prescribing Lumigan after noticing “beautiful, long lashes” on a patient using Lumigan for glaucoma. Now, she promotes Lumigan on her Web site as “easy to use at home with only a once daily application” for “one to three months to achieve the desired length, and then once weekly for maintenance.”
Klein says she feels comfortable prescribing Lumigan because it comes from Allergan, which sells other dermatological drugs and products. Some of her patients, she says, work for Allergan and have told her the drugmaker has recruited subjects for a clinical trial of Lumigan for cosmetic use. Klein notes that Lumigan’s safety has been validated by FDA tests, she adds, “it’s scary to me as a physician that some cosmetic companies are slipping in a prescription drug.”
Source: The Wall Street Journal
John
Scares the heck out of me. I used Lumigan for a period for ocular hypertension, and the side effects were incapacitating. After three retrials, they only became worse. Is there labelling on this thing?
Ed Silverman
Hi John,
Here’s the precribing info….
http://www.lumigan.com/46link%20-%20PI.pdf
ed at Pharmalot
Hank
The below just in from FDA on this product:
FDA informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, sold and distributed by Jan Marini Skin Research, Inc. of San Jose, California. The product was seized because it may lead to decreased vision in some users. The eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). Use of the prescription drug in addition to the eyelash product containing the drug, may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug’s effectiveness. Damage to the optic nerve may lead to deceased vision and possibly blindness. Other possible adverse events may include macular edema (swelling of the retina) and uveitis (inflammation in the eye) which may lead to decreased vision.
Dermatologists, estheticians, and consumers who may still have Age Intervention Eyelash should discontinue use and discard any remaining product. Consumers should also consult their healthcare professional if they have experienced any adverse events that they suspect are related to use of the product.
Read the complete 2007 MedWatch safety summary including a link to the FDA News Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Eyelash
Dr. Alan Bauman - Bauman Medical Group
I’ve prescribed Lumigan, as well as the other ‘cosmetic’ products, and witnessed DRAMATIC eyelash growth in our patients. In our patients, we’ve seen few, if any, side-effects other than minor, transient irritation. Bimatoprost, as well as other prostaglanding analogs, are considered by experts to be an exceptionally safe group of medication and even the FDA acknowledged that there have been no reports of decreased vision from these products. There are essentially no systemic side effects from prostaglandin analogs reported in the medical literature. If you consider the alternatives for those women who want enhanced lashes (mascara, false eyelash extensions, topical meds, and eyelash transplants), the topical treatment is quite a good option. Personally, I like the idea of keeping these treatments out of the salons and having them prescribed & dispensed under the supervision of physicians. We’ll have to wait and see how Allergan does defending their turf…