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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Baxter CEO Says Heparin Purposely Tainted

Yesterday on Capitol Hill, a house subcommittee heard testimony on the recent issue of contaminated Heparin. Robert Parkinson, CEO of Baxter testified that the company believes the heparin was deliberately tainted.

Most heart wrenching, was when the family’s victims told their stories on how the tainted Heparin has destroyed their lives.

Leroy Hubely, was in tears as he explained how his wife Bonney died in December 2007 and then a month later his son, Randy died under the same circumstances. Only after the recall of Heparin, did he learn from his local dialysis center that tainted heparin, and not some cruel twist of fate, led to both of their deaths.

His daughter-in-law Collen Hubely, a dialysis nurse, testified: “As a nurse, I thought that I would be there to save my husband from any errors, but I guess I was naive. I never thought the life saving medication we were relying on might be contaminated. If citizens are truly going to ever to feel safe in this country going to the hospital, a doctor, taking your daily medication; we have a responsibility to be make sure that everything that is given is free from contamination.”

Families demanded more stringent policies and testing to protect consumers from dangerous materials hidden in our medications.