(NaturalNews) In a move that shows how desperate pharmaceutical companies are for a new blockbuster drug, the FDA is about to approve a drug which will increase the length of eyelashes. This drug comes from Allergan Inc and is derived from Lumigan; a drug used in the treatment of glaucoma since 2001. Glaucoma is a condition in which the pressure within the eyeball is increased. Patients using Lumigan reported increased eyelash growth which prompted the development of the spin off drug Latisse. Allergan also makes Botox and expects sales of Latisse (bimatoprost) to top 500 million a year. The company anticipates launching the drug in 2009.
Last winter, the FDA forced Jan Marini, a cosmetic manufacturer, to pull a similar product off the market. The product was seized and banned because:
1: The FDA had not approved such a product.
2: Jan Marini did not have authority to sell a prescription drug over the counter.
3: Allergan had patent rights on the substance that was the active ingredient and was working on Latisse.
Latisse, 5% the strength of Lumigan, is a liquid applied daily to the upper eyelid like eyeliner. It will be available by prescription only and is not intended to actually go in the eye. In the one and only study conducted, Latisse was shown to make lashes darker, thicker and longer.
The drug was tested for safety on only 137 people. 141 used a placebo liquid and 137 people used Latisse for 16 weeks. The manufacturer states side effects were mild and reversible with no serious side effects confirmed. "The overall benefit-risk assessment of bimatoprost for eyelash growth is favorable due to the fact that risks are minimal and the aesthetic benefits are well-demonstrated and meaningful," the company said.
Prescribing information for Lumigan states: The drug may darken eyelid skin and gradually increase pigmentation of the iris, making eyes browner. Those iris color changes, which may not be noticeable for several months to years, may be permanent but don't progress after stopping Lumigan. Note the study on the safety of Latisse was 16 weeks long although these side effects in Lumigan are not seen for months to years.
Four of the 278 people in the study dropped out due to eczema, dry eye, inflammation of the eye and dermatitis. The FDA advisory board gave a unanimous recommendation that the drug be approved and although the FDA doesn't always follow the advice of the board, it is generally a good indication a drug will be approved. The FDA panel, composed of outside ophthalmologists and dermatologists, also recommended further studies to assess Latisse's use in certain groups of patients, such as young patients and people who lost their eyelashes because of chemotherapy.
There are concerns being expressed by physicians:
"I'm worried about off-label, nonsupervised use of this medication, and I'm concerned teenagers might use it three or four times a day instead of once," said Dr. Marijean Miller, an ophthalmologist with the Children's National Medical Center in Washington.
Other experts noted that only one African-American patient was included in company trials and state that Allergan should be required to show the drug's effectiveness in that population.
Some questions the FDA forgot to ask:
• What happens over the long term to people using this drug cosmetically that don't have glaucoma?
• What happened to the years of rigorous testing drugs used to have to undergo for safety? What can really be learned in 16 weeks? Will this drug be taken off the market in a few years because people's eyeballs have collapsed from reduced intraocular pressure?
http://www.dbtechno.com/health/2008/12/09/update-fda-set-to-approve-drug-...http://www.reuters.com/article/americasIpoNews/idUSN0332186720081203http://www.eyelashproducts.com/About the author
Patty Donovan was in a wheelchair and could only walk around her house with a cane. She was on over 20 medications. When told to "take the morphine, get in the wheelchair and learn to live with it" by a neurosurgeon, she knew her life had to change. She is now almost a fanatic when it comes to healing through the use of "whole foods" and and natural remedies. Since that time, she has spent countless hours researching nutrtion and alternative health. After spending 30 years in the allopathic health care industry in both pharmacy and as an RN, she brings a unique perspective to Natural News readers. Since committing to this new life style, she no longer uses even a cane, has gotten off over 20 medications, lost over 50lbs and returned to work.
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