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“Another Company Recalls Heparin”: The Case For Going “Full Tylenol”

Friday, March 21, 2008  |  posted by Hugh Hewitt
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A second heparin manufacturer has decided to recall all of its heparin on the fear that its supply has been contaminated as well:[# More #]

A manufacturer of the blood thinner heparin initiated a nationwide recall Friday because some products may contain a potentially dangerous contaminant. Contaminated heparin from a different manufacturer has been associated with 19 deaths and hundreds of allergic reactions.

In the recall announced Friday, B. Braun Medical Inc. said it was recalling 23 lots of heparin as a precautionary measure. No adverse events have been reported in connection with their product, company officials said in a press release.

The company issued the recall after one of its suppliers, Wisconsin-based Scientific Protein Laboratories, disclosed that an ingredient it provided contained oversulfated chondroitin sulfate, a chemical that does not occur naturally. Federal officials are investigating how the contaminant got into the drug.

Heparin is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China. Scientific Protein Laboratories owns a Chinese factory -Changzhou SPL -and buys additional raw heparin from other Chinese suppliers.

Since I began following this story last week, I have been amazed that MSM has paid so little attention to it, and that Baxter and the other firms involved as well as the FDA have been so quiet about the problem. The analogy to the famed Tylenol poisoning case is very strong, except that Tylenol was an over-the-counter medication, and heparin is not. But in both cases the public benefits from full disclosure of all relevant facts as soon as they are available. That’s what Johnson & Johnson did when the Tylenol deaths occurred in 1982. But nothing like is happening right now.

Were I in the Baxter HQ, I’d be urging the CEO to post a blog and flood it with as much info as they have about every reported case of heparin-associated death or illness, and the distribution data, pre-recall, of the tainted product and the dates during which it might have been in use, along with a comprehensive listing of associated side-effects and advice on contacting doctors.

When the lawsuits began to roll in, I expect they will make it an issue that Baxter was not quick to the public with this sort of information, and if there are long-term side effects associated with the contaminated drug that could be alleviated or avoided through prompt medical treatment, the passivity of the manufactures will be a source of enormous liability when it comes to light.

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