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UPDATE: FDA Reconsidering Midodrine Access

ACC urges FDA to reconsider process, access to the drug

The U.S. Food and Drug Administration (FDA) on Aug. 16 proposed to withdraw approval of the drug midodrine hydrochloride, used to treat orthostatic hypotension. According to the FDA, required post-approval studies that verify the clinical benefit of the drug have not been done.This is the first time that the FDA has chosen to exercise its authority to withdraw approval for a drug because of a failure to conduct adequate post-market approval studies.

In response to the announcement, the American College of Cardiology on Aug. 27 sent a letter to the FDA expressing its concern with the process, given that health care providers received "almost no notice of the impending withdrawal of the drug’s approval," which meant no time to prepare alternate courses of treatment or to investigate other options." According to the letter, "the very reason for the expedited approval of midodrine, few alternative therapies available for a life-threatening or serious disease, has not changed. No new evidence has come to light with respect to the side effects of the drug. While serious, the potential side effects of the drug are well-known to the prescribing community." The letter urged the FDA to revisit the process and to also take steps to ensure that there is true access to the drug. Read the full letter.

Update: The Associated Press on Sept. 6 reported that FDA representative Sandy Walsh "said in an emailed statement that the agency will continue to allow access to ProAmatine, also known as midodrine, 'while the necessary data is collected and the legal issues get sorted out.'" More recently, an article in "FDA Weekly" says the agency "intends to continue the process of withdrawing approval for the blood pressure drug midodrine hydrochloride." It goes on to say that the FDA "will not forbid market sales of the product while the necessary post-market efficacy data is aggregated. The entire withdrawal process could take years now that the brand-name manufacturer of the drug has requested a hearing." 

Physician Information: Meanwhile, when treating patients, physicians should refer to the current recommendations for the treatment of postural orthostatic tachycardia syndrome at Class IIb ( 2003 ACC/AHA/ESC Guideline for the Management of Patients With Supraventricular Arrhythmias, page 18), which remains appropriate as long as the drug is available. Should the drug become unavailable, an update will be posted and communicated expediently.

2003 ACC/AHA/ESC Guidelines for the Management of Patients With Supraventricular Arrhythmias – Page 18:
e. Treatment; PHARMACOLOGIC
Centrally acting (eg, methylphenidate, clonidine) or peripherally acting agents (eg, midodrine) have also been effectively used (171,172).
Page 19 - Recommendations for Treatment of Postural Orthostatic Tachycardia Syndrome
Treatment Recommendation Class Level of Evidence References
Pharmacologic*
Peripherally acting Midodrine IIb B (171,175)
*Combination therapy commonly required.

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