Glaxo Wellcome Ziagen
Executive Summary
Abacavir labeling changes added to black box warning, advising doctors about additional symptoms that may suggest a diagnosis of hypersensitivity, including infectious gastroenteritis and symptoms that appear to be due to another medication. Physicians are also advised that some patients developed hypersensitivity reactions after interruption and reinitiation of abacavir even if they had no prior hypersensitivity. The company sent out a "Dear Doctor" letter July 27. Another Dear Doctor letter was distributed in January informing physicians that respiratory symptoms, including sore throat, cough or shortness of breath, could indicate a hypersensitivity reaction (1"The Pink Sheet" Jan. 31, p. 20). The rate of hypersensitivity reactions continues to be 5% across all patient populations. Two to four out of every 10,000 patients who have taken Ziagen have developed fatal hypersensitivity
You may also be interested in...
Relenza Dear Doctor Letter In EU Follows U.S. Advisory
Glaxo Wellcome is warning European prescribers about potential side effects with Relenza one week after similar concerns were raised by FDA.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials