The Food and Drug Administration (FDA) has issued its first-ever proposal to withdraw approval of an approved drug because required postapproval studies that verify the clinical benefit of the drug have not been done.

The drug, marketed as ProAmatine^TM by Shire Development Inc. and as the generic midrodrine hydrochloride by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. The approval required that the manufacturer verify clinical benefit to patients through postapproval studies. ProAmatine is used to treat the low blood pressure condition orthostatic hypotension—a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.

To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities. Shire, the manufacturer of the brand name drug, must respond to the FDA in writing within 15 days to request a hearing. If it fails to do so, the opportunity for a hearing will be waived. Sponsors of generic versions of midodrine will have 30 days to submit written comments on the notice. If, after considering any relevant submissions, the withdrawal of FDA approval continues to be warranted, approval of both brand name and generic midodrine will be withdrawn.

Patients who currently take this medication should not stop taking it and should consult their healthcare professional for other treatment options. The FDA is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options.

1. Food and Drug Administration (FDA). News & Events. FDA News Release. FDA Proposes Withdrawal of Low Blood Pressure Drug. August 16, 2010. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm. Accessed August 18, 2010.

Posted in News Service
This entry was posted on Wednesday, August 18th, 2010 at 12:00 pm.