Should the government ban the sale of over-the-counter drugs in capsule form?
That step is being considered by the U.S. Food and Drug Administration in response to the nationwide recall this week of 12-hour Sudafed decongestant capsules. The recall was ordered following reports that Sudafed sold in the Seattle area was poisoned with cyanide, leading to two deaths and a serious illness.This is the third product-tampering case to result in a nationwide recall in the past decade. In 1982, seven people died in the Chicago area after extra-strength Tylenol capsules were contaminated with cyanide. In 1989, all shipments of Chilean grapes to the United States were quarantined after trace amounts of cyanide were found in two red seedless grapes. Neither case was ever solved.
The Chilean grape episode shows that a ban on capsules is no cure-all, since a determined poisoner could easily switch to poisoning fruit, milk, eggs, or liquid medicines. Indeed, as Americans become more knowledgeable about science and technology, the threat of tampering with non-capsule pills and tablets can be expected to increase.
Instead of a ban on capsules, what's needed now is an education program aimed at alerting the public to signs of tampering.
Since the 1982 deaths of seven people in Chicago from cyanide-laced Tylenol capsules, manufacturers of over-the-counter medicines have been required to include two tamper-resistant features in each product. Sudafed has not just two but three: a blue band around the middle of the capsule itself, a foil seal on a blister pack, and a plastic tape on the outside of the box.
The FDA says the poisoned packages in Seattle showed obvious signs of tampering - the blue band was gone on one of the capsules, it contained a yellower, finer powder and the foil on the back had been cut and re-sealed with tape.
The lesson should be clear: Tamper-resistant isn't tamper-proof. Despite improvements in product design and packaging, there's no guaranteed safeguard against some determined madman. And there's still no substitute for paying close attention to the pills we take and the packages they come in.