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 "manufacturers...spot 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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FDA Links 100 Deaths to Heparin Since 2007

Late yesterday, the FDA announced publicly that over 100 patients within the United States have died while taking the blood thinning medication Heparin since January 2007.

The FDA found that over 62 of the deaths are the result of allergic reactions to contaminated batches of Heparin, which is significantly higher than their previous estimate of 19 deaths. Many of these deaths were not reported when they occurred, but are only now being reported to the FDA.

Allergic reactions to heparin are rare with only 3 deaths reported in 2006. However these increased in 2007, jumping dramatically to 8 in November, 12 in December, 16 in January, and 11 in February. FDA has posted the month to month mortality statistics on their website.

The presumed cause of the increased reactions is the adulterated compound the FDA discovered in the recalled products, whose ingredients were imported from China (See: Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin).

China is a major supplier of raw heparin, which is derived from pig intestines. Recent decreases in swine population, due to blue ear disease, have caused Chinese plants to turn to smaller wholesalers for their own supply. Chondroitin-Sulfate is less expensive than its genuine heparin counterpart, which may explain why it was incorporated in the raw heparin.

In answer to this major threat, recalls have expanded to seven countries: U.S., Germany, Japan, Denmark, France, Italy, and Australia. Furthermore, the FDA has upgraded the pharmaceutical testing of imported Heparin.