Magazine article Drug Topics

After the Ban

Magazine article Drug Topics

After the Ban

Article excerpt

When an over-the-counter drug is banned by the Food & Drug Administration, retailers are usually allowed to sell whatever stocks they have left, even though manufacturers are barred from shipping new supplies of that particular product. (See "Latelines," May 22.)

A recent U.S. News & World Report investigation focused on this practice. The article stated that OTC drug bans are seldom publicized and that the FDA has no formal mechanism in place by which to inform consumers or pharmacies of either a ban or a recall.

Asked about this, FDA spokeswoman Ivy Kupec explained that when the FDA issues a recall--a more serious step than a ban--it sends out a press release to the wire services and to all major newspapers as a way of notifying consumers. These releases are also picked up by broadcast media.

There are different levels of recall, she also noted. They range from the recall of a subpotent drug to a Class 1 recall, which directs consumers to remove a specific product from their medicine cabinets immediately. In addition, the FDA's weekly enforcement reports, which list recalls, also go to subscribers.

Most recalls take place because a product is subpotent or inconsistent or because there's a problem with manufacturing. Some problems are so minor that people don't even hear about them, she said. "We inform consumers if there's an imminent health risk," explained Kupec.

U.S News & World Report cited the case of a woman who took OTC quinine sulfate tablets to treat leg cramps. Within a short time, her kidneys failed. She remained in critical condition for nine days and has since filed a suit against the manufacturer of the quinine tablets as well as against the pharmacy that sold her the drug. The manufacturer continues to maintain that its quinine sulfate wasn't to blame for the woman's illness. However, the FDA announced on Aug. …

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