Pharmaceutical Drug Midodrine Not Yet Established as Beneficial, FDA Says
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Midodrine, a pharmaceutical drug used to control blood pressure, may soon find itself off pharmacy shelves due to a lack of follow up studies. Midodrine, sold under brand name ProAmatine, is an oral pharmaceutical drug used to treat patients with low blood pressure. The medication belongs to a class of drugs known as vasosuppressors, which help alleviate symptoms related to low blood pressure such as fainting, light-headedness and dizziness.
What Action will the FDA Carry Out in Regards to the Prescripiton Drug
The FDA has expressed concern that follow up studies have not been done by Shire Pharmaceuticals, the drug’s manufacturer, to demonstrate the pharmaceutical med’s clinical benefits. The drug was approved on an accelerated basis, on the condition that it support the medication’s clinical benefits with follow up clinical studies. 144 follow-up clinical studies are required for fast-track approvals and complete studies have not been sent to the FDA.
The FDA has responded swiftly by taking action to remove the prescription drug from the market within the next 30 days. Shire and its generic manufacturers have been given 30 days to respond in writing to the motion. Even if data is supplied, the FDA may still remove the pharmaceutical from pharmacy shelves if studies are deemed inadequate.
The FDA’s motion is the first of its kind against a rapidly approved drug. The FDA has recommended that current users seek alternative medical therapy in the interim and consult their physician. 100,000 patients throughout the United States are currently taking pharmaceutical drug midodrine.
