Midrodrine hydrocholoride (ProAmatine)  Will Come off Pharmacy Shelves Effective September 30th

For many patients with autonomic dysfunction the simple act of standing up or being upright is difficult if not impossible.  Some patients have what’s called low blood pressure, otherwise known as orthostatic hypotension or postural hypotension meaning that the person’s blood pressure falls when a person changes position and stands up.   The fall in blood pressure can cause patients to pass out and have reduced blood flow to major organs of the body. 

Postural Orthostatic Tachycardia Syndrome (POTS), which is a type of autonomic dysfunction, has been treated successfully with two main types of medications, one being beta blockers and the second being Midrodrine. For more information,  you may want to view the video below featuring Dr. Phil Fischer, MD, from the Mayo Clinic talk about POTS and how it effects patients.

POTS Discussion with Dr. Phil Fischer, MD Of the Mayo Clinic

 

The FDA proposed that approval of the drug would be withdrawn, because, according to the FDA “post approval studies that verify the clinical benefit of the drug have not been done.” 

Shire Pharmaceuticals, which markets the  drug, issued a statement on August 17th saying that they were withdrawing the product which would become effective September 30, 2010.   Shire also states on their website that they did complete post marketing trials that were required by the FDA. The FDA, says, that the studies conducted by Shire were “inconclusive” and mandated that Shire conduct additional studies if Shire were to continue marketing the drug. 

There were no safety considerations involved whatsoever with regards to Midrodrine.  And conducting additional studies can take years and millions of dollars.

If you think that decisions like this don’t affect you, think again. Medical decisions and which drugs are available to you as a patient may be based more on dollars and cents, rather than common sense.

Have you ever wondered why newer antibiotics aren’t hitting the marketplace? Even in an era where the top scientists are saying they are desperately needed, and we have new strains of drug resistant “super bugs” thought to have originated in surgery centers in India and spreading around the world? 

The answer may surprise you. Because drug manufacturers would rather develop more profitable drugs that are taken daily, instead of antibiotics that are taken for a limited amount of time. 

How much does it cost to bring a drug to the marketplace?
That’s tricky. In 2003, some studies were conducted that reported costs of around 800 million to bring a new drug into the marketplace.  2006 studies reported numbers that were even higher, with figures ranging from 500 million to 2 billion dollars.

I don’t know how much it would’ve cost Spire Phamaceuticals to redo clinical studies that were already done in order to satisfy the FDA. But obviously it was not cost effective for them to do so. This leaves many patients vulnerable, some may even not survive in severe cases because a drug which helps them moderate their blood pressure will no longer be available.

Patients are noticeably upset as are their medical providers. Another vulnerable population that has orthostatic hypotension issues are hemodialysis patients. And considering the rise in diabetes patients in the United States, this has the potential to be a very big deal.

If you ask physicians, researchers, study authors and patients, Midrodrine has proved to have clinical efficacy.

Midodrine: a role in the management of neurocardiogenic syncope. Ward CR et al Heart. 1998 Jan;79(1):45-9. Observations on midodrine in a case of vasodepressor neurogenic syncope Ward et al Clin Auton Res. 1995 Oct;5(5):257-60.

Spinal cord patients, have also benefited from Midrodrine by preventing severe orthostatic hypotension,  if their injuries were above T6, when given to them about 30 minutes before getting them out of bed.
Arch Phys Med Rehabil. 2009 May;90(5):876-85

A systematic review of the management of orthostatic hypotension after spinal cord injury.
Krassioukov A, Eng JJ, Warburton DE, Teasell R; Spinal Cord Injury Rehabilitation Evidence Research Team.
International Collaboration on Repair Discoveries, University of British Columbia, Vancouver, BC, Canada.

Obviously, there are certain parameters that drug marketers must go through in order to satisfy certain criteria and ensure that the public has access to safe and effective medications. But if our bureaucracy and red tape continues to expand and medium sized pharmaceutical companies have no incentive to produce innovative medications that can be life enhancing or life saving, where does that leave you and me?   Where does that leave your children?

Below is an Excerpt from the FDA’s News Release:

FDA Proposes Withdrawal of Low Blood Pressure Drug

Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

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.

Orthostatic hypotension is 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.

 

Here is the Press Release Issued by Shire Pharmaceuticals:

Philadelphia, USA – August 17, 2010 – Shire plc (LSE: SHP, NASDAQ: SHPGY) acquired ProAmatine as a part of the acquisition of Roberts Pharma in 1999 and Shire conducted and completed the post marketing trials that the FDA required.  The FDA, however, viewed these trials as inconclusive and required that additional trials be conducted for ProAmatine to maintain its marketing authorization.  As a result, Shire elected to withdraw the product effective September 30, 2010 and notified the FDA in November 2009 and healthcare professionals earlier this year of this decision.  Shire’s withdrawal of the NDA was not related to any concerns regarding the safety of ProAmatine.