Monday, October 5, 2009

FDA: New Manufacturing Standards May Decrease Heparin Potency by 10%.

Given Secure Pharma Chain Blog’s extensive covering of the issues with Heparin the past year, the following involves the widely reported story which appeared in a variety of news publications regarding changes to the manufacturing Heparin in an effort to prevent further complications with the often used medication.

The FDA recently announced that "New manufacturing standards designed to prevent contamination of the blood-thinner heparin will decrease the drug's potency and may require patients to get higher doses." Beginning October 8th, "heparin products...will be about 10 percent less potent than the current medicine used to prevent blood clots, which was posted on the" agency's website.

Dr. John Jenkins, director of the FDA's office of new drugs, stated that "healthcare providers should consider the change in potency of heparin when making decisions about which dose to administer.”

  • Although "older vials of heparin will remain on the market after the new formula begins shipping," which may "cause confusion, the agency said it was necessary to ensure there is adequate supply of the drug."

  • The Dow Jones Newswire reports that the agency has asked manufacturers to change labels on the new products to help pharmacies and physicians identify them from the older vials.

  • According to the Chicago Tribune, the new standards are intended to help " impurities during the quality-control process." The new controls follow "last year's recall by...Baxter International Inc. of its heparin vials linked to a spike in deadly allergic reactions."

  • CQ HealthBeat reports. Jenkins noted that "the change 'may have clinical implications in some situations' where the drug is given in a large dose to produce an immediate anti-coagulant effect." But, Jenkins added that "the change in potency is expected to be less clinically significant when administered subcutaneously,"

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