FDA committee to review OTC decongestants
ROCKVILLE, Md. The Nonprescription Drugs Advisory Committee will consider the possibility of a revision to the final monograph for over-the-counter decongestants following a review of the safety and efficacy of phenylephrine in a Dec. 14 meeting, FDA said in a notice prepared for the Oct. 24 Federal Register, according to the Tan Sheet.
The meeting is one day after the FDA considers the potential switch of Merck’s Mevacor for the third time.
At the Dec. 14 meeting, the committee will discuss questions on the safety and effectiveness of PE hydrochloride and PE bitartrate in nonprescription decongestants raised in a Feb. 1 citizen petition.
The petitioners—University of Florida pharmacy professors Leslie Hendeles and Randy Hatton—assert that available data does not support the adult and pediatric dosing levels recognized as safe and effective in the monograph for OTC cough, cold, allergy, bronchodilator and antiasthmatic drug products. They requested FDA revise the monograph to increase the adult dose of PE hydrochloride from 10 mg to 25 mg and PE bitartrate from 15.6 mg to 40 mg.
Last week a pair of FDA advisory committees voted to discontinue the recommendation of children’s cough-and-cold remedies for children under the age of six.
Weight loss rather than adverse effects driving patient satisfaction with alli
NEW ORLEANS Data presented at the 2007 Annual Scientific Meeting of NAASO, the Obesity Society, found that patient satisfaction with alli, the only FDA- approved, over-the-counter weight loss product, was connected to the product’s effectiveness in helping them lose weight, and not to potential gastrointestinal treatment effects.
Treatment effects are characterized by predictable GI side effects when alli is taken with meals with too much fat.
This is important because these data show that the weight loss achieved with alli strongly motivates subjects to continue treatment regardless if they are experiencing treatment effects.
“Since having my first child, I have been carrying around extra weight and now I’m a mother of three,” stated Jaime Clear, a 28-year-old alli First Team member from Henderson, Nev. “I committed to losing the weight with alli and have lost 20 pounds in 10 weeks. The treatment effects have been manageable and have kept me honest about my diet.” The alli First Team is a group of 406 men and women that was formed after alli was approved by the FDA, and given the opportunity to use alli at no cost before it was available in stores.
In the study, less than 5 percent of subjects stopped taking alli because of treatment effects and were able to maximize their weight loss.
The analysis of controlled studies shows that during the first week of treatment with alli, the overall incidence of most treatment effects was generally low—between 3 percent and 8 percent. The overall rate was 33 percent lower when compared to those taking Xenical (which has 120 mg of orlistat, the active ingredient, as compared to the 60 mg dose found in alli). Researchers determined that when alli was used for three months without physician supervision in a non-controlled setting, the overall incidence of treatment effects was 20 percent lower compared to controlled studies.
“The alli data we’re reviewing show that treatment effects are not a major issue for most patients taking alli because they are highly motivated by the weight loss achieved,” stated Vidhu Bansal-Dev, GlaxoSmithKline Consumer Healthcare director of medical affairs. “In addition, many alli users have repeatedly told us that they view treatment effects as a positive tool to help make them aware of hidden fats in foods.”
In addition to the cumulative data analysis released at NAASO, recently collected consumer data show overall satisfaction with the alli weight loss program was ranked at 85 percent among alli First Team members. Moreover, a new consumer survey conducted by Nielsen and funded by GlaxoSmithKline Consumer Healthcare showed nearly 70 percent of people reported losing weight after starting the alli program.
Amerifit reformulates its AZO Cranberry supplement
CROMWELL, Conn. Amerifit Nutrition on Monday announced the reformulation of its AZO Cranberry supplement to include Probiotic Lactobacillus Sporogenes and vitamin C.
Two tablets now combine 900 mg of natural cranberry powder concentrate, 100 million
CFU’s of Probiotic Lactobacillus Sporogenes to impede the colonization of bad bacteria and stimulate the immune response, with 60 mg of Vitamin C, which acts as an antioxidant.
Studies have shown that cranberry helps block the attachment of urinary tract infection-causing bacteria to the urinary bladder wall, the company reported.
A 50-count package of the new supplement will retail at a suggested price of $8.99.