Elmiron: Ineffective, Dangerous—And Still on the Market
Another striking case is
Elmiron, approved in 1996 for interstitial cystitis—a painful bladder condition.
The FDA authorised it based on “close to zero data,” on the condition that the company conduct a follow-up study to determine whether it actually worked.
That study wasn’t
completed for 18 years—and when it was, it showed Elmiron was no better than placebo.
In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalised with colitis. Some died.
Yet Elmiron is still on the market today. Doctors continue to prescribe it.
“Hundreds of thousands of patients have been exposed to the drug, and the American Urological Association lists it as the only FDA-approved medication for interstitial cystitis,” Lenzer and Brownlee reported.