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Is there a tetracycline shortage?

Consumer Reports News: August 08, 2012 04:33 PM

Q: I've heard that there's a nationwide shortage of the antibiotic tetracycline. Is this true?

A: Yes. Nearly 30 pharmacies around the country told our Consumer Reports Secret Shoppers last week that they don't have tetracycline in stock and didn't know when they were going to get it. Some pharmacy employees pegged the start of the shortage to a December 2011 recall by one manufacturer Teva, due to particulate matter within the packaging. But why there is still a shortage of it is unclear.

Tetracycline hydrochloride is listed on the Food and Drug Administration's list of Current Drug Shortages, which notes that Teva and another company, Watson, the only two manufacturers of the drug nationwide, both "cannot estimate a release date" for the drug, due to manufacturing delays. Both companies told us they are unable to obtain the active ingredient of tetracycline.

Tetracycline is used to treat bacterial infections, including pneumonia and other respiratory tract infections; acne; skin infections, urinary and genital infections and the H. pylori infection that causes stomach ulcers.

The American Society of Health-System Pharmacists (ASHP), an organization which tracks drug shortages and related issues, also confirmed that both companies were still experiencing shortages. "With only two manufacturers and a raw material shortage, this shortage likely affects most, if not all, pharmacies," says Bona E. Benjamin, B.S.Pharm., coordinator of ASHP's Drug Shortages Resource Center.

A third company, Impax Laboratories, also has FDA approval to manufacture tetracycline. But instead of producing that drug, IMPAX manufactures generic doxycycline, which is in the same drug class as tetracycline. A company spokesperson told us that IMPAX does not manufacture it because the market for it is not "attractive."

How can a shortage of such a common drug occur? It's not clear, and the FDA doesn't know either. An FDA spokesperson told us that they're willing to help the companies involved, but they'd need more information to do so.

Neither Teva nor Watson has said that it will permanently discontinue tetracycline, but the shortage appears to have no end in sight.

Bottom line: If your doctor prescribes tetracycline and your local pharmacies can't fill the prescription, ask your doctor for a new prescription for a drug in the same class: doxycycline or minocycline. "Doxycycline has more or less taken over the market because of its availability, and because it's only taken twice a day," says Marvin M. Lipman, MD, Consumer Reports' chief medical adviser. "Tetracycline has to be taken four times a day."

You might get compounded tetracycline from a pharmacy that's state-certified for compounding, but the resulting medication could be more expensive than doxycycline, Lipman says. One pharmacy in Hickory, N.C., The Compounding Pharmacy, told us they could compound it. Although it would cost more than buying the regular capsules, the pharmacist there, Bill Mixon, RPh, says it would be affordable nevertheless. If you do get it compounded, just make sure the pharmacy is accredited by the Pharmacy Compounding Accreditation Board.

What about buying it online? Think again, ASHP's Benjamin says. "We strongly discourage patients from attempting to obtain tetracycline from Internet sites since there is significant risk of receiving counterfeit or adulterated products."

Source:
List of current drug shortages [U.S. Food and Drug Administration]

Lisa Fields

   

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