Thursday, August 19, 2010

US FDA Proposes To Withdraw Approval of Low Blood Pressure Drug Midodrine Hydrochloride

US FDA Proposes To Withdraw Approval of Low Blood Pressure Drug Midodrine Hydrochloride As Phamaceutical Companies Could Not Provide The Evidence of Clinical Benefit of Drug.

The United States F D A has first time in history has taken a step and proposed to withdraw approval of the drug midodrine hydrochloride, Midodrine Hcl is used to treat orthostatic hypotension a low blood pressure condition.

In orthostatic hypotension patients are not able to maintain blood pressure in the upright position and , therefore, when they stand up suddenly becomes dizzy or faint.

US FDA took this action on the pharmaceutical companies as the granted approval for drug requires a post market or post approval surveillance study and these companies have not done the required post-approval study which is required to verify the clinical efficacy and other untoward outcomes of drug like adverse effect and adverse reactions.

US FDA has asked peoples who are currently taking this drug should not stop taking it, rather they should consult their doctor or health care professional for other alternative treatment options.

US FDA said in their new release that , the drug marketed as ProAmatine by Shire Development Inc. as well as its generic version by others, were approved in 1996 under the FDA’s regulations for drugs that treat serious or life-threatening diseases, an accelerated approval to ensure the life saving treatment is made available to peoples quickly. Such approval requires that the manufacturer carries out a post approval studies to verify clinical efficacy of the drug, and to ascertain that there are no adverse effect associated with the use of such drugs.

So far until the date FDA issued the press release they said that these companies nighther the original maufacturere of midodrine hydrochloride nor the companies which are granted approval for its generic versions have not done any post approval studies to demonstrate drugs clinical efficacy for example, by showing that use of the drug improved a patient’s ability to perform life activities.

This is a first time that US FDA has issued such a notice for a drug approved under the FDA’s accelerated approval regulations.

Pharmaceutical company Shire, is the owner of the brand name drug ProAmatine which contains midodrine hydrochloride, has been requested by US FDA to respond to the FDA in writing within 15 days to request a hearing and If the company fails to do so, FDA said the opportunity for a hearing may be waived.

Sponsors of generic versions of midodrine are given a time period of 30 days for submitting a written comments on the FDA’S notice. And if FDA still belives that that withdrawal of approval is warranted, even after considering any relevant submissions, the approval of all midodrine products, including generic versions, FDA said will be withdrawn.

Midodrine as a generic drug is manufactured by following pharmaceutical companies
Apotex Corp.
Impax Laboratories Inc.,
Mylan Pharmaceuticals,
Sandoz Inc.,
Upsher-Smith Laboratories.

Under accelerated approval program (FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases ) a pharmaceutical company gets an approval for a drug to be used to treat a serious or life-threatening disease or condition considering a surrogate endpoint.

What is a surrogate endpoint :
It is a clinical marker, indicating a physiological or pharmacological effect after use of a drug like a positive effect on blood pressure, surrogate endpoint are used to predict actual clinical benefits such as improved survival or decreased severity of the disease.

It is mandatory for pharmaceutical companies getting approval for a drug under fast track approval to conduct additional post approval study (also see clinical trials) after approval to confirm the drug’s benefit and to find out any untoward outcome.

If in such clinical trials drug is found not confirming its clinical beneficial effects to patients, or if the companies do not conduct the required confirmatory trials with due diligence, the FDA can withdraw approval of the drug using expedited procedures.

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