Pravachol is Bristol-Myers Squibb's biggest selling drug with $2.26 billion in sales in 2002. The New York-based company spent $31.5 million in ad spending last year on Pravachol.
The company said it received the FDA's request in a tersely worded eight-page letter Aug. 7 and is working with the FDA to resolve the issues. In addition to ending the camapign, the FDA has told Bristol-Myers Squibb to promptly make available correct information to the "audiences that recieved the misleading messages."
The FDA charged that "promotional materials are false or misleading in that they claim that Pravachol has been approved by the Food and Drug Administration for conditions and patients for which it has not been approved."
Some of Pravachol's advertising claims that the drug is the only cholesterol-lowering medication proved to prevent first and second heart attacks and strokes in people with high cholesterol or heart disease, an assertion the FDA said is "false."