Miracle Drug Comeback?

001128_Attkisson_Lotronex CBS

Lotronex was Maria Zargo's miracle drug, the only thing that curbed her debilitating symptoms from irritable bowel syndrome (IBS).

Since Lotronex was pulled from the market, she's been desperately rationing the little she has left, reports CBS News Correspondent Sharyl Attkisson.

"My supply is running low, I'll be out of the medication in August. Right now I'm cutting the pills in half to make it last longer," said Zargo.

She lives in fear of the disabling bouts of diarrhea and pain brought on by IBS that forced her to quit work, and left her unable to take care of her family. Lotronex has given Zargo her life back.

It's the little-known story behind drugs taken off the market: some patients are robbed of their only effective treatment. Now the Food and Drug Administration (FDA) is considering something it's never done before: bringing Lotronex back — because so many patients are lobbying for its return.

A return of Lotronex is unthinkable to Kathy McCormick, who says the drug made her sicker than the IBS it was supposed to treat.

"I just think it's not a good idea to put it back on the market — they should keep it off permanently," said McCormick.

The advocacy group Public Citizen says the risk increases the longer someone takes Lotronex and recently told that to the FDA.

In a letter, Public Citizen says it will be responsible for the "needless deaths and serious injuries..." if it allows the drug back without the strictest of limits on who gets it and how they're monitored.

At last count, Lotronex was blamed for 127 severe reactions and at least four deaths.

And some FDA scientists concluded in an internal memo last November that no risk management plan will eliminate the problems, and "early warning of the dire side effects... is clearly not feasible."

But thousands of Lotronex supporters like Corey Miller say it works for them and they're contemplating what life will be like if their pill supplies run out.

"I really feel like I'm fighting for my life and the quality of the rest of my life," said Miller.

The hardest part will be striking a balance between those who insist Lotronex is too risky, and others who say it's their only chance at a real life.



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  • Amanda Straniero

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