US Public Citizen 'told you so' about Zelnorm

US pressure group, Public Citizen, has issued a statement pointing out that it had warned against the approval, by the Food and Drug Administration in 2001, of Switzerland-based drug major Novartis' constipation-predominant diarrhea drug Zelnorm (tegaserod maleate; see page 3). The drug has been withdrawn at the request of the FDA, citing safety concerns.

Sidney Wolfe, Public Citizen's Health Research Group director, said: "in 2004, we warned readers of our Worst Pills, Best Pills newsletter not to take Zelnorm because of the dangers involved."

He added that, "despite our warnings, the FDA approved a drug with marginal effectiveness in the face of serious questions about its safety - putting at risk the millions of people who have already used it. Today, the FDA has asked the company to withdraw the drug from the market only after even clearer evidence of harm. This again raises questions about both the adequacy of the FDA's pre-approval review and post-marketing surveillance."