Hot off the press for October 31, 2005

October 31, 2005 Public interest groups to FDA: Ban triclosan products Expert panel reevaluates DEHP Wyeth files petition over bio-identical HRT Kentucky Renaissance Pharmacy Museum opens Personal Products to acquire Rembrandt from Gillette Delsym launches campaign to healthcare professionals Abbott issues urgent correction for blood glucose meters Genco acquires Capital Returns Walgreens to acquire selected assets of Medic drugstores Tennessee pharmacy school names first dean Express Scripts completes Priority purchase VA warns vets of Rx scam Public Citizen to FDA: ED drugs need black box warning Rite Aid offering flu, pneumonia shots Public interest groups to FDA: Ban triclosan products Public interest groups have petitioned the FDA to ban the antibacterial agent triclosan in household products because of evidence that it causes health and environmental effects and leads to antibiotic resistance. The chemical is found in antibacterial soaps, deodorants, toothpastes, cosmetics, fabrics, and plastics. The groups are asking the FDA to recognize the problem and expedite action to ban household triclosan use after an FDA advisory panel found that the chemical doesn't provide any more protection than using soap and water. Jay Feldman, executive director of Beyond Pesticides, the lead petitioner, issued this statement: "The failure to regulate triclosan as the law requires puts millions of people and the environment at unnecessary risk for toxic effects and elevated risk for other bacterial diseases." Back to top Expert panel reevaluates DEHP The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) recently convened an expert panel to reevaluate the reproductive and developmental toxicities of di(2-ethylhexyl)phthalate (DEHP). A wide variety of consumer products, including cosmetics, building and car materials, clothing, food packaging, some children's toys, and even some medical devices, often contain chemicals referred to as phthalates. Levels of concern expressed by CERHR panels include negligible concern, minimal concern, some concern, concern, and serious concern. The panel said it has minimal concern that general population exposure adversely affects adult human reproduction. However, the panel stated, "If the level of exposure is at the high end of the estimated exposure range for the general population, the panel had some concern that exposure to DEHP can adversely impact reproductive development in male children older than one year. The panel has concern that DEHP exposure can adversely affect reproductive development in infants less than one year old." These conclusions are a refinement of the first panel's conclusion of concern for the entire infant/toddler population. Back to top Wyeth files petition over bio-identical HRT Wyeth has filed a citizens' petition urging the FDA to take enforcement action, including warning letters, injunctions, and seizures, against some pharmacies that compound bio-identical hormone replacement therapy (BHRT). The petition alleges that some BHRT compounders engage in the "growing unlawful manufacture and marketing" of such products. The Wyeth petition is not directed at pharmacies that compound individual products for individual patients whose needs cannot be met by an FDA-approved product. In response, the International Academy of Compounding Pharmacists charged that Wyeth's petition is flawed. IACP said that Wyeth is accusing compounding pharmacies of producing new untested drugs on the one hand and claiming that bio-identical hormones are illegal because they are copies of existing pharmaceuticals on the other hand. You can't have it both ways, IACP argued. Back to top Kentucky Renaissance Pharmacy Museum opens The Kentucky Renaissance Pharmacy Museum recently celebrated its grand opening. The museum is located on the ground floor of the old Fayette County Courthouse in Lexington, Ky. Several rooms display memorabilia from the practice of pharmacy in Kentucky and from pharmacists who were educated in Kentucky. The museum is open to the public. Back to top Personal Products to acquire Rembrandt from Gillette Personal Products Co., a Johnson & Johnson company, announced that it has entered into a definitive agreement to purchase the Rembrandt Brand of oral care products from the Gillette Co. The transaction is anticipated to close in the fourth quarter of 2005. The Rembrandt Brand equity is based in tooth-whitening products. As part of the agreement, Personal Products will acquire all of the consumer and professionally dispensed Rembrandt Brand products, including whitening toothpastes, whitening strips, whitening systems, and mouth rinses. Back to top Delsym launches campaign to healthcare professionals UCB Pharma is touting Delsym (dextromethorphan polistirex) in a direct mail campaign targeted to healthcare professionals. The product is an OTC 12-hour cough suppressant. The campaign will reach an estimated 65,000 nurse practitioners, physician assistants, pediatricians, and pharmacists through a three-wave mailing program. Each of the mailings will feature the theme, "Long. Longer," emphasizing the product's 12-hour extended efficacy. Back to top Abbott issues urgent correction for blood glucose meters Abbott Diabetes Care, a division of Abbott, Alameda, Calif., is voluntarily initiating a correction and notification to users of its blood glucose meters in the United States. The products are sold under several model names, including FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, and MediSense Optium. Private-label brands include ReliOn Ultima, Rite Aid, and Kroger blood glucose meters. Test strips are not affected by this correction. The company has received consumer complaints that in the course of setting the time and date for their meters, users have inadvertently changed the units of measure from milligrams per deciliter (mg/dl) to millimoles per liter (mmol/L). This could lead to misinterpretation of test results with possible undertreatment and the potential for hyperglycemia. Consumers using Abbott Diabetes Care blood glucose meters may continue to safely use their meters and should verify that their meter is displaying the correct unit of measure each time they test. For information, call 1-(800) 553-4105. Back to top Genco acquires Capital Returns Genco has acquired Capital Returns, a pharmaceutical returns management and disposition firm headquartered in Milwaukee. The company will operate as a separate Genco business unit. Genco is a firm that specializes in supply chain management, serving a diverse range of manufacturing, retail, and government customers in North America, Australia, and the United Kingdom. Back to top Walgreens to acquire selected assets of Medic drugstores Walgreen Co. announced that it will acquire selected assets of Medic drugstores, a 23-store chain in Cleveland and the surrounding area. Walgreens is acquiring the assets from Hilco, a retail restructuring specialist and agent for Medic. Once finalized, Walgreens will convert eight Medic locations to the Walgreens banner. The transaction doesn't include Medic's home healthcare division, which Medic will continue to operate. Back to top Tennessee pharmacy school names first dean Larry Calhoun has been chosen as the founding dean of the East Tennessee State University's College of Pharmacy in Johnson City. Calhoun, who was previously president-CEO of Wilson Pharmacy and Home Health in Johnson City, was involved in strategic planning for the school. The $7.5 million facility expects to enroll its first class of 65 students for the 2006 fall semester. Back to top Express Scripts completes Priority purchase The pharmacy benefit manager Express Scripts has completed its purchase of the specialty pharmacy Priority Healthcare. The $1.3 billion cash sale will make Priority a part of CuraScript, Express Script's specialty pharmacy subsidiary. The combined operation will have estimated annual sales of more than $3 billion. Back to top VA warns vets of Rx scam The Department of Veteran Affairs issued a scam alert after reports that a company identifying itself as the Patient Care Group was claiming that it now fills VA scripts. The firm has reportedly told veterans that if they don't provide their credit card numbers, they will not receive their medications. The VA has advised veterans not to give out their numbers because the agency has not changed its process for receiving and dispensing prescriptions. Back to top Public Citizen to FDA: ED drugs need black box warning Consumer advocacy group Public Citizen is urging the FDA to immediately require black box warnings on erectile dysfunction drugs to alert consumers that the products may cause irreversible vision loss. In an Oct. 20 citizen petition filed with the FDA, Public Citizen noted that Pfizer's Viagra (sildenafil citrate) accounts for more cases (about 19%) of a type of vision loss called nonarteritic anterior ischemic optic neuropathy (NAION) than any other drug and more than double the percentage of the next most often reported drug. The group derived its figures from an analysis of the FDA's adverse events database. Back to top Rite Aid offering flu, pneumonia shots Some Rite Aid pharmacies are offering flu and pneumonia immunization clinics now through the end of November. A list of participating locations and the date and time of each clinic are available at