ProAmatine Recall: FDA Proposes to Withdraw Drug Approval
The FDA is proposing to remove drug approval for the low blood pressure drug ProAmantine and its generics, which would result in a ProAmantine recall from the market.
The FDA announced its intention to withdraw approval for ProAmantine on Monday after the manufacturer, Shire Development Inc. failed to show that the drug provided clinical benefits to its users. Before it takes the regulatory action, the FDA had to issue a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to Shire and the companies that make the generics.
ProAmantine (midodrine hydrochloride) was approved by FDA in 1996 for the treatment of the low blood pressure condition called orthostatic hypotension. It was approved under an accelerated process reserved for drugs that are needed to save lives. Under the terms of the approval, the manufacturers had to conduct post-market studies to show that the drug provided a clinical benefit to patients. At the time of its approval, all it needed to show FDA was a surrogate endpoint believed to be a predictor of actual clinical benefits, which in this case was increased blood pressure.
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Learn MoreAfter 14 years, neither Shire nor the manufacturers of generic midodrine hydrochloride have provided proof that the drug actually helps individuals live longer or more comfortably, the FDA claims. The generic manufacturers include Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.
In its press release announcing the proposed approval recall of ProAmatine, FDA officials state that this is the first time the agency has been forced to take this kind of action against a drug that has undergone the accelerated approval process.
“We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients,” said FDA Cardiovascular and Renal Drugs Director Dr. Norman Stockbridge. “Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing withdrawal of the product.”
Shire has 15 days to respond to the FDA in writing to request a hearing or else the opportunity for a hearing will be waived. Generic manufacturers have 30 days to submit comments.
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7 Comments
DonnaSeptember 9, 2010 at 3:44 am
My 15 yr old daughter has been on this drug for one year after finally being correctly dxd with POTS. Proamatine has given her her life back. She cannot function without it. It allows her to get out of bed and remain upright throughout the day, she can go to school, now she can eat again and have bm's without getting physically ill --nauseous, the sweats, shaking, going pale and feeling as if she [Show More]My 15 yr old daughter has been on this drug for one year after finally being correctly dxd with POTS. Proamatine has given her her life back. She cannot function without it. It allows her to get out of bed and remain upright throughout the day, she can go to school, now she can eat again and have bm's without getting physically ill --nauseous, the sweats, shaking, going pale and feeling as if she will faint and prevents the chest pain and shortness of breath she was experiencing. PLEASE PLEASE DONT TAKE AWAY HER LIFE LINE! CANT IMAGINE HER LIFE WITHOUT IT. THIS IS HEARTBREAKING AND CRUEL THAT WE WONT HAVE ACCESS TO THE MEDICATION THAT IS SAVING HER LIFE.
ChristineSeptember 1, 2010 at 3:00 am
I have taken midodrine for 13 years, and it is the only medication that allows me to function. With it, I work, volunteer in my community, am a productive citizen. Without it, I will be unable to walk across my living room, I will become disabled. The government/FDA is harming US citizens with this recall, and they have the power to prevent our suffering. The safety of this drug is NOT at question[Show More]I have taken midodrine for 13 years, and it is the only medication that allows me to function. With it, I work, volunteer in my community, am a productive citizen. Without it, I will be unable to walk across my living room, I will become disabled. The government/FDA is harming US citizens with this recall, and they have the power to prevent our suffering. The safety of this drug is NOT at question; this makes no sense.
sydneyAugust 30, 2010 at 12:50 am
my best friend uses this drug and if you take it away she will not be able to walk. why would you take something away when it is helping patients with POTS.
abbyAugust 29, 2010 at 5:58 pm
I am seventeen years old and have had POTS for two years now. I am slowly starting to get my old life back thanks to the drug proAmatine. Taking this drug away will set me back to be worst then when i was diagnosed with POTS. Isnt their any way they can give this stictly only to POTS patients because every patient i know that is on this drug depends on it. I want to have a good senior year and tak[Show More]I am seventeen years old and have had POTS for two years now. I am slowly starting to get my old life back thanks to the drug proAmatine. Taking this drug away will set me back to be worst then when i was diagnosed with POTS. Isnt their any way they can give this stictly only to POTS patients because every patient i know that is on this drug depends on it. I want to have a good senior year and taking away this drug pretty much knocks that out.
BonnieAugust 27, 2010 at 11:03 pm
I have been on this medication for over 8 years. It has helped to stabilize my condition -so what can I expect will happen when I have taken this four times a day. Has the FDA looked at the whole picture? What about all the people on it - are the going to take responsibility for Health issues that will occur when they ban it??? Look at the whole picture and not just the paperwork. FDA you are[Show More]I have been on this medication for over 8 years. It has helped to stabilize my condition -so what can I expect will happen when I have taken this four times a day. Has the FDA looked at the whole picture? What about all the people on it - are the going to take responsibility for Health issues that will occur when they ban it??? Look at the whole picture and not just the paperwork. FDA you are dealing with human lives or has this administration thrown humanity away to cut the costs to pay for the pork!!!!
CherylAugust 23, 2010 at 3:28 pm
This drug has really helped my son. he depends on it 6x a day and has HELPED HIM TREMENDOUSLY. I can not imagine what my sons life will be without it. he is finally getting better and to take this med away would be devastating.
RebeccaAugust 17, 2010 at 7:54 pm
This drug has helped my daughter! What documentation is required to show the FDA the clinical benefits of this drug? Our doctor has the bp readings from before and after taking these meds. What else could they possibly need?