AEGiS-WSJ: FDA Voices Concern Over New HIV Drugs Wall Street JournalImportant note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
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FDA Voices Concern Over New HIV Drugs

Wall Street Journal - April 21, 2007


The Food and Drug Administration said it was concerned about a proposed new class of HIV drugs that have been associated with increases in the risk of liver damage, lymphoma and infections.

The agency raised its concerns ahead of a meeting of an outside panel of medical experts that will meet Tuesday to make recommendations about a Pfizer Inc. drug called maraviroc, a new type of drug known as a CCR5 co-receptor antagonist. Unlike current HIV drugs on the market that are designed to treat the virus, maraviroc is designed to block a receptor on cells known as CCR5 to keep HIV from infecting healthy cells.

The FDA said other CCR5 drugs that were being developed have shown an increased risk of safety problems. Pfizer said its studies showed the drug had no significant effect on the heart, and no raised incidence of liver problems, cancer or infection compared with treatment with other HIV drugs.


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