Warner-Lambert Responds To Rezulin's Negative Press
Warner-Lambert Co. (WLC) recently issued a statement in response to the "mischaracterization of its actions and intentions" in recent media reports, regarding the development and marketing of Rezulin (troglitazone), the Company's therapy for type 2 diabetes. According to WLC's statement, the Company has always been forthcoming with information regarding the safety and efficacy of this therapy with both the U.S. Food and Drug Administration and health care professionals. The statement also expressed WLC's dismay at recent media coverage of the drug, which it says has focused primarily on the risks but largely ignored the significant patient benefits of the medication.
"Therapies such as Rezulin bring tremendous benefit to hundreds of thousands of patients every day," the statement claims. "However, like other anti-diabetic agents, and most other prescription pharmaceutical products, Rezulin may be associated with certain side effects. And while there may be rare adverse hepatic events associated with Rezulin, these events must be viewed in the context of the hundreds of thousands of patients that are currently benefiting from the drug."
According to WLC, there are more than 15 million people with type 2 diabetes. Many of these people go on to experience the effects of this disease, such as blindness, amputation, kidney failure and ultimately death. "It is in that context that the benefit to risk ratio must be weighed," the statement points out, "and why the Company maintains, and the FDA continues to support the view, that the benefits of Rezulin outweigh its risks."
Recent media reports have stated that there have been a total of 33 deaths in the U.S. and Japan. According to WLC, these deaths primarily involved patients who may not have been monitored as recommended in the labeling. The Company's statement also points out that each of these events occurred with patients that started therapy prior to the most recent changes in labeling. With proper monitoring, the Company believes health care professionals can keep these rare but serious events to an absolute minimum. WLC claims that since the first label revisions in 1997 recommended periodic monitoring of liver function, the rate of serious liver-related adverse events has fallen substantially.
To date, more than 1.4 million patients in the U.S. have begun Rezulin therapy.
For more information: Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950, USA. Telephone: 973-540-2000.