Food and Drug Administration (FDA) officials are making it much harder to get a “miracle drug” that helps people eat normally who would otherwise have to rely on a feeding tube, according to an Arizona think tank’s investigation.
The drug Domperidone was not approved by the FDA, but, until recently, was fairly easily obtained from compounding pharmacies, Goldwater Institute investigative reporter Mark Flatten reports. Compounding pharmacies craft highly specialized drugs for specific patients and are now under tighter scrutiny from the agency.
The report details the lives of patients suffering from gastroparesis, “a potentially deadly condition in which food basically sits in the stomach rather than being digested and passed normally,” Flatten wrote. Sufferers typically vomit most of the food they consume instead of digesting it.
Domperidone is a proven treatment for gastroparesis, with one doctor calling it a “miracle drug.” Patients using the drug are able to eat normally without vomiting.(RELATED: Suit Alleges Former FDA Chief Suppressed Danger Of ‘Deadly’ Drug For Sake Of Profit)
Flatten describes a seven-year-old patient who developed a fear of feeding after living her first three years relying on a feeding tube and regularly vomiting. She was then successfully treated with Domperidone, but the FDA’s crackdown may force her to go back to the feeding tube.
The FDA’s major concern is a link between Domperidone and a heart condition called QT Prolongation, which is “a pause in the electrical buildup in the heart between beats,” Flatten wrote.
Janssen Pharmaceutical applied for FDA approval of Domperidone in 1985, but the agency wanted more evidence the drug was safe. The company instead withdrew its application without explanation.
But the tie between the medicine and the QT condition is overhyped by the FDA, and studies showing the link have been highly criticized, according to Flatten.
Meanwhile, about 150 FDA-approved drugs linked to QT prolongation are on the market, and Domperidone is available in more than 100 countries and is often sold over the counter.
Regardless, Domperidone users Flatten interviewed believe the drug’s benefits outweighed the risks and now must overcome additional hurdles in the face of the FDA’s stricter control.
Domperidone patient Colleen Beener, 62, had been on the drug for 15 years and took it because “she cannot lead anything resembling a normal life without it,” Flatten wrote.
“When I’m not taking it, I don’t get out of bed,” Beener told Flatten. “I’m so sick, I can’t do anything. But when I take it, I have days that I can go watch my grandkids swim or play soccer or whatever. As far as I am concerned, that’s the risk-reward balance that I have to take.”
It’s become increasingly difficult for Beener to get Domperidone. She wouldn’t divulge where she now gets her supply, fearing that the FDA would shut down her supplier.
“She has effectively been forced onto the black market because of the FDA’s actions, she said,” Flatten wrote.
Some patients buy their Domperidone in Mexico, where they can’t be sure of its quality or be told of the safe dosage.
FDA officials refused Flatten’s requests for interviews.
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