Regulatory News In Brief

Orlistat benefits outweigh risks, EMA says; J&J, Energizer to study SPF 85; Health Canada warns about Miracle Mineral Solution; Regencea recalls RegenArouse; more Regulatory News In Brief

Orlistat benefits outweigh risks, EMA says

The benefits of weight loss drugs containing orlistat – including GlaxoSmithKline Inc.’s OTC alli – outweigh their risks, the European Medicines Agency says. There is “no strong evidence” that orlistat increases risk of liver injury and “no known mechanism” by which the drug is expected to cause liver disorders, EMA said in a Feb.16 release. EMA started the review in August at the request of the European Commission after “spontaneous reports of liver injuries.” The agency recommend uniform labeling for orlistat products, including generics authorized in some European Union markets, to ensure the warning about liver damage is consistent. FDA investigated the connection between orlistat and hepatitis and added a warning about rare reports of severe liver injury to the drug facts box (Also see "FDA Alerts Public To Ongoing Safety Review Of Orlistat In GSK, Roche Drugs" - Pink Sheet, 31 Aug, 2009.). Most recently, FDA announced it is studying the link between orlistat and kidney stones (Also see "FDA Evaluates Alli For Potential Serious Risk Of Kidney Stones" - Pink Sheet, 16 Jan, 2012.).

J&J, Energizer to study SPF 85

Johnson & Johnson Consumer Inc. and Energizer Personal Care propose to study consumer use and the efficacy of sunscreens with sun protection factor 85. The firms explain in a Feb. 1 letter to FDA that the study will address the agency’s concerns with a previous study designed to demonstrate the superiority of the higher SPF to SPF 50. FDA dismissed the previous study in a review on which it based a proposal to cap sunscreen SPFs at 50 (Also see "FDA Considers Capping SPF Values At 50+ Despite Efficacy Data" - Pink Sheet, 20 Jun, 2011.). The new study will instruct subjects to use the sunscreen “as they normally would” to determine if they sufficiently reapply, among other questions, the firms explain.

Health Canada warns about Miracle Mineral Solution

Health Canada warns Miracle Mineral Solution, promoted to cleanse toxins from the body, includes a hard surface disinfectant that caused four adverse effects in Canada, including one life-threatening reaction. The distributor, www.themmsstore.com, agreed to remove the product from the Canadian market. It includes 200 times more sodium chlorite than the tolerable daily intake established by Health Canada. The regulatory agency notes the sale of sodium chlorite for human consumption violates the Food and Drug Act and no therapeutic products with the ingredient are authorized for human consumption. FDA in 2010 warned U.S. consumers that MMS is an unapproved drug and can cause serious adverse reactions. The agency said it would consider civil or criminal enforcement (Also see "FDA warns of MMS dangers" - Pink Sheet, 9 Aug, 2010.).

Regencea recalls RegenArouse

Regeneca voluntarily recalls one lot of RegenArouse after FDA found the prescription erectile dysfunction ingredient tadalafil in the product. The Irvine, Calif., firm Feb. 11 said the unlabeled active ingredient makes the product an unapproved new drug and could interact with nitrates in some prescription drugs resulting in dangerously low blood pressure. FDA is cracking down on tainted supplements, and sexual performance products are a main target (Also see "FDA, Trade Groups Team Up To Bolster Enforcement On Tainted Supplements" - Pink Sheet, 20 Dec, 2010.). The firm said an outside lab tested the product and found no PDE-5 inhibitors, but it added it later learned “there was an error on this test” and recalled the product.

Two Vagifresh products recalled

USA Far Ocean Group recalls Vagifresh Gel because it contains the undeclared painkiller benzocaine, the active ingredient in anesthetic drug products, FDA announces in a Feb. 16 consumer update. The Los Angeles firm also recalled Vagifresh Ball because it is contaminated with harmful bacteria, the FDA adds. The two products were sold as cosmetics but relied on unproven treatment claims related to gynecologic conditions. The agency worries the claims could have caused women who used these products to delay or not seek proper medical attention for potentially serious ailments. The products also were sold together with Vagifresh Liquid in a package named Female One. Vagifresh Liquid has not been recalled.

Healthy People supplements recalled

FDA testing found the banned weight-loss drug sibutramine and the erectile dysfunction ingredient tadalafil in products sold as supplements by Healthy People Co. The agency and firm announced a recall Feb. 3 of seven stock-keeping units, including Mince Belle and Perfect Men supplement capsules and Ever Slim shake mixes. The recalled products were sold at Healthy People’s Irwindale, Calif., store and can be returned to that location, the firm said.