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FDA Committee Vote Confirms Darvon’s Risks Outweigh Benefits, Drug Should Be Banned

Statement of Sidney Wolfe, M.D., Director, Health Research Group at Public Citizen

Today’s Food and Drug Administration (FDA) advisory committee vote confirms that the risks of propoxyphene (Darvon) outweigh its benefits. The FDA must, therefore, remove it from the market.

Most advisory committee members did not think there was evidence that the drug has significant benefits. Without benefit, serious risk of death – which this drug carries – should not be tolerated. In Florida alone, medical examiners determined that propoxyphene caused the deaths of 85 people in 2007. For 25 of those people, it was the only drug that caused their deaths. These latest data come atop years of other data showing that the drug’s risks outweigh its benefits.

How much more evidence does the agency need? We again urge the FDA to do the right thing and ban this drug.

Read Wolfe’s testimony to the committee.

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