Latebreakers: February 6, 2006

February 6, 2006

The FDA has unveiled a major revision to its prescription druginformation format, commonly called the package insert. The changesinclude the following: Highlights, a section that will provideimmediate access to the most important prescribing informationabout benefits and risks; Table of Contents, for easy reference todetailed safety and efficacy information; the date of initialproduct approval; and a toll-free number and Internet reportinginformation for suspected adverse events. Commenting on the plan,Consumers Union said the proposal will make existing drug safetyand risk information clearer to physicians, but the new plan fallsshort of dramatically improving drug safety for consumers becauseit does not require better safety measures from drugmakers.

FDA unveils new Rx drug information format

The FDA has unveiled a major revision to its prescription drug information format, commonly called the package insert. The changes include the following: Highlights, a section that will provide immediate access to the most important prescribing information about benefits and risks; Table of Contents, for easy reference to detailed safety and efficacy information; the date of initial product approval; and a toll-free number and Internet reporting information for suspected adverse events. Commenting on the plan, Consumers Union said the proposal will make existing drug safety and risk information clearer to physicians, but the new plan falls short of dramatically improving drug safety for consumers because it does not require better safety measures from drugmakers.

Labeling changes made for Clozaril

Liver toxicity reported with telithromycin use

The FDA has issued a public health advisory following reports of three patients who experienced serious liver toxicity after administration of telithromycin (Ketek, Sanofi-Aventis), published in a recent issue of Annals of Internal Medicine. One of the three patients recovered, one required a liver transplant, and one died. All patients were previously healthy and were not taking other prescription medications. The FDA said it would continue to evaluate the issue in order to determine whether labeling changes or other actions are necessary. In the meantime, the agency recommends that healthcare providers continue to monitor patients taking the antibiotic for signs or symptoms of liver problems and discontinue therapy when these signs are present.

New labeling and guide for topical calcineurin inhibitors

A new boxed warning states that rare cases of malignancies have been reported in patients treated with tacrolimus (Protopic, Astellas Pharma) and pimecrolimus (Elidel, Novartis). The FDA approved the new labeling for the eczema treatments following reports of skin cancer and lymphoma. The new labeling reminds healthcare professionals that the topicals are considered second-line treatments and other therapies should be tried first. The FDA also warned that although the companies are currently conducting studies to learn more about the cancer risk, it could be years before the research is finished. Pharmacists will now be required to distribute an FDA-approved Medication Guide that informs patients how to use the drugs safely.

Part D plans must cover 30-day transition scripts

CMS has instructed Medicare Part D Rx drug plans that they must provide a 30-day supply of any drug a beneficiary was taking prior to Jan. 1 and that they must not charge poor beneficiaries more than $2 for covered generics or $5 for brands. Fearing political fallout from the rocky launch of its drug program, the Bush Administration is working to clear up snafus that have led at least 20 states to step in to pay for medications for Medicaid patients who were switched to Part D but were not listed on the rolls.