Poisonings may change drug packaging FDA may ban capsules after Sudafed scare.


The nationwide recall of Sudafed 12-Hour Cold Capsules, after two deaths and a serious injury were linked to cyanide-laced capsules, could accelerate the disappearance of over-the-counter capsule medicines and lead to a ban on such forms of medicine by the Food and Drug Administration.

At the very least, the action may raise questions for companies and consumers about whether they should steer clear of capsules.

Events of the last few days have provoked new discussions at the FDA on banning the use of capsules in over-the-counter medicines, according to Jeff Nesbit, chief spokesman for the agency.

Every major case of product tampering since the Tylenol deaths in the early 1980s has involved capsules, and all the companies that sold the products involved have since abandoned the use of capsules. But many other companies still use them.

Burroughs Wellcome Co., maker of Sudafed, already has applied for FDA approval of a solid-form, caplet version of Sudafed, according to spokeswoman Kathy Bartlett.

The latest deaths and injury, all in Washington state, underline the fact, as Bartlett put it, that "we've known all along that tamper-resistant is not tamper-proof."

Kathleen Daneker, 40, of Tacoma, died Feb. 11 after ingesting one of the capsules two days earlier. Stanley F. McWhorter, 44, a Lacey real estate broker, died Feb. 18, also after taking one of the pills.

The first victim, 28-year-old Jennifer Meling of Tumwater, fell into a coma Feb. 2 after taking a Sudafed 12 Hour, but she eventually recovered.

Burroughs Wellcome issued a national recall Sunday, after learning Saturday night that the two deaths could be tied to Sudafed capsules.

The company has told consumers, retailers and wholesalers to turn in all Sudafed 12-Hour Cold Capsules for refunds. The company will end up destroying about 1 million packages of the product, said the spokeswoman.

The latest cases bring up a question that has nagged at the industry, and at consumer groups, for years: Why use capsules at all?

"It's irresponsible for any company to be selling" this form of technology, said Sidney Wolfe, a doctor and director of Public Citizen Health Research Group, a consumer rights organization. He called for the FDA to ban capsules.

There are several reasons the capsules still are around, said Jack Walden, senior vice president of the Nonprescription Drug Manufacturers Association in Washington.

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