FDA Approves “Eyelash Fertilizer”

The Food and Drug Administration (FDA) has approved the cosmetic use of an eye disease drug, allowing it to be sold as an eyelash enhancer.
Currently called Lumigan, the drug is produced by Allergan, the same pharmaceutical company responsible for Botox.
Lumigan was originally developed to treat glaucoma; however, researchers at Allergan discovered that patients who used the drug grew thicker, longer and darker eyelashes as a result. Allergan plans to call the product “Latisse” when marketing it cosmetically and expects the repurposed drug to generate about a half a billion dollars annually, the Associated Press reports.
An Allergan-conducted review tested 278 patients over the course of 4 months, intending to confirm that the drug increased thickness, length and darkness of lashes. A review of the study by the FDA showed that participants using the drug saw significant cosmetic changes, as compared to patients who received a placebo.
Last Wednesday, the FDA posted a review of the active ingredient in Lumigan on its Web site, preceding an independent review of the drug by medical experts, who voted on Friday to approve the drug for cosmetic purposes.
The panel of eye and skin specialists voted unanimously that the drug’s benefits outweighed its risks, according to WPVI, ABC’s Philadelphia affiliate. However, the panel also voted 5–3 that Allergan should be required to continue studies on certain patient groups.
Allergan says it will sell Latisse under a “risk management plan” meant to encourage doctors to explain and monitor possible side effects. The drug can lower intraocular eye pressure (which is why it’s used as a glaucoma drug) and may cause skin darkening in some users.
However, some doctors believe these safeguards may be not be sufficient to prevent potential abuse of the drug. Dr. Marijean Miller, ophthalmologist with the Children’s National Medical Center in Washington said, “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.”

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FDA Panel to Scrutinize Safety of Some Asthma Treatments

A Food and Drug Administration panel is going to hold hearings this week to review the safety of a particular group of asthma medications after the agency’s staff recommended the drugs be prohibited for kids 18 and younger, Reuters reported.
The drugs in question are known as long-acting beta agonists (LABAs), and there are concerns that they are linked to “asthma-related deaths and asthma attacks,” the news service said.
The medications that could be affected are Foradil, which is made by Novartis AG and marketed in the United States by Schering-Plough Corp.; Advair and Serevent, which are both made by GlaxoSmithKline; and Symbicort, which is made by AstraZeneca.
Serevent and Foradil shouldn’t be used by people of any age with asthma, FDA staff has said.
According to the Philadelphia Inquirer, who cited FDA documents, kids ages four to 11 taking LABAs “appeared to be at greatest risk for complications than those taking older treatments.”
Long-acting beta agonists are inhaled along with steroids. LABAs keep constricted airways open for at least 12 hours, according to the Mayo Clinic, and reduce the use of what are known as “rescue medications” that quickly open up airways. LABAs are useful at night, and people who took them reported waking up less, and having a better quality of life than those who only took steroids for asthma, the clinic said.

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