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FDA Crack Down on Domperidone Leaves Patients with Life-Threatening Condition Few Options

October 25, 2016

Phoenix—Cassie Le’s seven-year-old daughter was put on a feeding tube when she was seven months old. Four years ago, doctors tried a new treatment that worked so well the feeding tube was removed and the girl was able to eat normally. Now, the FDA is blocking the Le family and thousands of others from accessing the only drug that allows them to live a normal lives.

Today the Goldwater Institute released an investigative report documenting the FDA’s efforts to cut off access to domperidone, a drug commonly used throughout the world to treat a potentially deadly medical condition called gastroparesis.

Domperidone is available in more than 100 countries, including Canada and throughout the European Union. In many of those countries it is sold over the counter. Since its introduction in 1978, domperidone has been a common treatment for such things as heartburn and bloating, as well as more serious conditions like gastroparesis.

In the past couple of years, the FDA has been aggressively enforcing an import ban on domperidone. Patients who until recently had little trouble filling prescriptions for the drug can no longer get it. And people who had previously benefited from this drug are being forced off the only medication that has allowed them to live normal lives.

Those who can no longer get domperidone face terrible consequences. They are people like Cassie Le’s daughter. “I fear she will need to get a feeding tube again,” Le said. “How do I tell her that? She is a little girl who has worked extremely hard to overcome her fears of eating. And now, her joy of being a normal little girl will be taken away.”

Colleen Beener, 62, of Florida, said she has taken domperidone for 15 years, and she has never had any heart problems associated with the drug. “I am choosing quality of life over quantity of life,” Beener said. “I don’t want to spend my days in bed. And if I get 10 years less because of that, so be it. I want to enjoy my grandkids. I want to enjoy my life, and domperidone helps me do that.”

Now, the only way to legally obtain the drug in the United States is through an FDA-authorized “expanded access” program. Agency officials refuse to say how many people are accessing the drug through its program.

FDA guidance for physicians who want to treat patients with domperidone shows they must agree to a litany of requirements which include developing monitoring and treatment plans for each patient, reporting adverse events, and securing approval from institutional review boards, which aren’t always readily available. Front-line physicians and medical professionals, and even members of the FDA’s own review committee, have called the agency’s expanded access program unworkable, cumbersome and impractical.

Federal legislation is pending that would make drugs that have been approved in other developed countries like Canada, European countries, and Japan available to Americans without delay.

Read the new Goldwater Institute report Sickening: FDA Bureaucracy Blocks Common “Miracle Drug.”

Sickening: FDA Bureaucracy Blocks Common “Miracle Drug.”

 

 

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