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FDA intercepts illegally imported drugs
Wednesday, January 28, 2004 Posted: 10:10 AM EST (1510 GMT)WASHINGTON (AP) — Medicines such as codeine and Valium and potent hormones with instructions written only in Chinese are among the latest illegally imported drugs intercepted by the government.
The Food and Drug Administration’s spot inspection of shipments from Canada and elsewhere netted 1,728 medicines unapproved for sale in this country.
The agency released results this week of its inspection, conducted in November in Chicago, Illinois; Seattle, Washington; Dallas, Texas; Buffalo, New York; Cincinnati, Ohio; and Memphis, Tennessee.
Thousands of Americans order prescriptions from Canada, where brand-name medicines can cost half the price. Proponents say it’s a safe way to lower drug costs, but the practice is illegal and the FDA calls it dangerous.
FDA hasn’t targeted patients but it is trying to shut down their suppliers. And this latest inspection suggests patients aren’t the only customers: FDA also uncovered batches of foreign flu vaccine, presumably destined for municipalities with shortages.
The agency wouldn’t identify who ordered the shots, saying investigations remain open.
Eighty percent of the intercepted drugs were shipped from Canada, but some actually were manufactured in such places as India, Pakistan and Thailand, FDA found.
FDA said the controlled substances and numerous other drugs posed risks, including:
• Foreign versions of the widely used blood thinner warfarin. Warfarin’s potency can differ depending on manufacturing conditions, leading to bleeding problems.
• A version of the acne drug Accutane, which can cause birth defects, shipped without the pregnancy testing required here before women buy it.
• The experimental drug atrasentan, labeled as “medical study cancer samples” intended for research use.
• Many that contained no instructions or side effect warnings. Labels on some were not written in English, including human growth hormone labeled only in Chinese.
