WHY LINZESS KILLS MICE

Quote

Anonymous

Guest
Just met with a GI today who saw your booth at the ACG in Las Vegas. He asked, "The Linzess booth didn't have much information. What do you think about your newest competitor?" He was surprised to learn that it has a black box warning and asked why. I told him, "It's because Linzess causes a significant electrolyte imbalance and kills young mice. Just imagine if a patient's children or grand children got ahold of it and ate it. Would you want to take that chance?" He responded that he couldn't believe the FDA would approve a drug that dangerous. Good luck selling the rat poison!
 






The abortifacient activity of lubiprostone is evident in the data from the pregnant guinea pig study. A preliminary range-finding study showed that abortions occurred in 4% of pregnant females at a dose of 5 micrograms per kilogram (µg/kg). That study was followed by a second, larger study showing dose-dependent abortions beginning at 1 µg/kg. Abortions occurred in 0%, 3.8%, 8.0%, and 19% (0, 1, 10, 25 µg/kg) (see Figure 1). There were 22 to 26 pregnant guinea pigs for each dose. The 1 µg/kg dose in guinea pigs is approximately the same exposure as the 48 µg dose in women.
 












Top Bottom
Back
Quote