FDA approves first natural latex glove
ROCKVILLE, Md. The Food and Drug Administration on Wednesday cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States.
Traditional latex gloves are made from the milky sap of a rubber tree, Hevea braziliensis. The sap contains a protein that may trigger allergic reactions, especially after prolonged and repeated contact, the agency stated. Sensitized people may experience mild reactions such as skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, shock may occur.
Estimates vary, but anywhere from 3 percent to 22 percent of all healthcare workers are sensitized to traditional latex. Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins.
“This approval has the potential to make a significant difference to both the general public and the medical community at large,” stated Daniel Schultz, director of FDA’s Center for Devices and Radiological Health. “Gloves made from guayule latex may prove to be a safer alternative for some people with sensitivity to traditional latex. And yet they will not sacrifice the desirable properties of traditional latex such as flexibility and strength.”
Health care workers first began using traditional latex gloves in the 1890s. But concerns about allergic reactions increased in the late 1980s after modifications in glove materials made them more sensitizing just as glove use was soaring in response to the HIV epidemic. Some health care institutions have since responded by shifting to alternative glove materials for their workers.
A 1998 rule requires that all medical devices containing latex carry a statement on the label warning about the risk of allergic reactions. Because there is no data on people’s long-term experience with the Yulex glove, the product will carry a warning for now about the potential for allergic reactions.
ADA petitions FDA to crack down on natural weight-loss claims
CHICAGO The American Dietetic Association last week filed a joint citizen’s petition to the Food and Drug Administration regarding the weight-loss claims made by marketers of dietary-supplement-containing diet aids.
“The American Dietetic Association this week is joining with three other groups in asking the U.S. Food and Drug Administration to raise the scientific standard bar for weight-loss supplement health claims,” the ADA noted in its weekly online newsletter published Friday.
The groups, which filed the petition April 17, are asking the FDA for changes in the regulation of weight-loss supplements so that manufacturers would be required, on the basis of credible scientific evidence, to obtain prior FDA approval of weight-loss claims.
Traditionally, regulating weight-loss claims made in advertising has fallen under the purview of the Federal Trade Commission. That would change, however, if the FDA were to rule that weight-loss claims are a disease state claim, as the citizen’s petition argues.
The ruling could weaken the ability of makers of natural diet aids to market their products to consumers, stacking the deck in favor of GlaxoSmithKline’s over-the-counter medicine weight-loss drug Alli, the one brand that would still be able to make weight-loss claims under those restrictions.
The move would potentially drive more of the $180.3 million in diet aid tablet sales that Alli doesn’t already control into GSK’s bucket. According to Information Resources Inc., Alli alone generated sales of $118.9 million for the 52 weeks ended Jan. 27, across food, drug and mass channels (excluding Wal-Mart), accounting for 32.2 percent of all dollars spent in the category and 13 percent of all units purchased.
GSK, according to the ADA report, is one of the companies that has signed the petition. The other petitioners are Shaping America’s Health and the Obesity Society.
The general public already assumes the FDA is governing dietary supplement diet aid claims, the ADA claims. According to ADA statistics, some 34 percent of consumers have used weight-loss products, and 46 percent believe that the FDA regulates natural diet aids for efficacy, which it does not.
Perrigo files FDA application for OTC generic of Monistat
ALLEGAN, Mich. Perrigo on Monday announced that it has filed an abbreviated new drug application for over-the-counter miconazole nitrate vaginal cream, 2 percent and Suppository, 1.2g, a generic version of Monistat 1 Combination Pack.
Monistat 1 Combination Pack is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million through food, drug and mass merchandisers for the 12 months ended March 2008, as measured by Information Resources, Inc., Perrigo reported.
According to Perrigo, McNeil challenged Perrigo’s ANDA with a suit filed Friday alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product.