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Wyeth Pharmaceuticals announced that ethionamide (Trecator-SC) sugarcoated tablets have been reformulated to film-coated tablets and renamed Trecator.
New formulation of ethionamide tablets also has new name Wyeth Pharmaceuticals announced that ethionamide (Trecator-SC) sugarcoated tablets have been reformulated to film-coated tablets and renamed Trecator. The film-coated tablet is more rapidly absorbed, resulting in higher peak concentrations of ethionamide, which could lead to patient intolerance when introduced at the same initial dose as the sugarcoated tablet. As a result, patients should be monitored and have their dosages retitrated when switching from the sugarcoated to the film-coated tablet. The MedWatch 2005 Safety Summary is available at: http://www.fda.gov/medwatch/SAFETY/2005/safety05. htm#Trecator .
AAD: Topical corticosteroids should remain Rx The American Academy of Dermatology (AAD) has issued a statement in response to a proposed change being considered by the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee that would switch topical corticosteroids from Rx to OTC status. The statement reflected AAD's concern that patients could self-medicate without being monitored by physicians for serious side effects associated with long-term or improper steroid use.
Program to identify narcotic use trends wins award Anthem Blue Cross Blue Shield has received a national award from researchers at Harvard Medical School and the Blue Cross Blue Shield Association for its program that helps healthcare professionals identify patients who are using narcotics inappropriately. Anthem's clinical pharmacy staff identified a "Rule of Three" pattern of pharmacy claims among members: three or more narcotic Rxs written by three or more physicians and filled at three or more different pharmacies within a three-month period. The program, which was piloted in Indiana, Kentucky, and Ohio, has expanded to include eight Anthem Blue Cross Blue Shield Plans.
Avonex labeling amended Biogen and the FDA have notified healthcare professionals of revisions to the label and Medication Guide for interferon beta-1a (Avonex). Severe hepatic injury has been reported in patients taking Avonex. Asymptomatic elevation of hepatic transaminases has also been reported. In some cases, these events occurred in the presence of other drugs associated with hepatic injury. The potential risk of Avonex used in combination with known hepatotoxic drugs or other products (including alcohol) should be considered prior to Avonex administration, or when adding new drugs to the regimen of those already on Avonex. The MedWatch Safety Summary is available at: http://www.fda.gov/medwatch/safety/2005/safety05.htm#Avonex .
R.Ph.s to review Medicare formularies Up to 145 clinical R.Ph.s will be available to review drug plans' proposed formularies under the Medicare prescription drug benefit. Potential drug plan sponsors had until March 23 to submit their bids to participate in the Rx benefit. During the month-long review period beginning April 18, 20 CMS pharmacists and 125 on-call R.Ph.s will evaluate proposed formularies to be sure they meet 14 standards. CMS will accept or reject the formularies by May 18.
Diabetes drug is the first approved in 80 years for Type 1 The FDA has approved pramlintide (Symlin, Amylin Pharmaceuticals) for injection to be used in conjunction with insulin for the treatment of Type 1 and Type 2 diabetes. Pramlintide is to be used at mealtimes in patients who have failed to achieve desired glucose control despite optimal insulin therapy. Pramlintide will be commercially available in approximately 90 days.