Food and Drug Administration Commissioner Arthur Hull Hayes Jr. released a list of packages the FDA considers tamper-resistant yesterday and said he will seek approval this week for a quickly written new regulation requiring such packages for all non-prescription drugs.
More than 100 "copycat" poisonings had been recorded around the nation by the FDA since seven people died of cyanide-tainted Tylenol in Chicago beginning four weeks ago today. The tampering incidents now cover more than a dozen states and include food such as pies and candy as well as eye drops, mouthwash and pain relievers.
"We are now seeing a wave of 'me-too' crimes . . . , " Hayes said. "It doesn't help to panic in difficult situations whether they are hijackings or holdups or poisonings, but it does help to be alert and aware . . . . A prudent consumer needs to examine products before taking them or giving them to a child."
Hayes said yesterday that the FDA will submit to the Office of Management and Budget this week a new federal packaging requirement for non-prescription drugs. After clearance by the OMB, the regulation will be published in the Federal Register and will go into effect as soon as manufacturers can produce the packages, an FDA spokesman said.
Hayes gave a list of the type of packages that are tamper-resistant: bubble, blister, or strip packs (in the bubble or blister pack, the medicine is sealed between plastic and a foil or cardboard backing; in a strip pack individual capsules are sealed in long cellophane strips); foil seals or plastic pouches; sealed tubes; aerosol cans; sealed or wrapped cartons, or containers with caps that must be broken to be opened.
Hayes said these packages are tamper-resistant "in that tampering may result in breaks in the materials which alert consumers can see and report to their pharmacist or retailer."
Forensic psychiatrist Dr. Jason Rappeport of Johns Hopkins University said that copycat incidents often follow well-publicized crimes of many different sorts.
"In this case, the press has dragged this thing out as far as anybody could possibly do," he said. It is possible that continued publicity stimulates further crimes by unstable, frustrated people who may see an opportunity to strike out at a presumed enemy or target, he said.
In Denver, the most recent copycat poisonings began Monday night when William Sinkovic, 33, took three Excedrin capsules that doctors say may have been contaminated with toxic mercuric chloride. Yesterday, Sinkovic was undergoing dialysis in a continuing attempt to clean the mercury compound from his system. He was in critical condition.
A second person suspected of being poisoned by tainted Excedrin capsules in Denver was Emily Jurick, 20, who took two capsules Monday night for flu-like symptoms. She was taken to the hospital when she developed stomach cramps, headache and other symptoms in the middle of the night.
Last night, however, FDA and Denver General Hospital doctors reported that the capsules she had taken were not tainted with mercuric chloride or cyanide.
In Aurora, Colo., officials at Stanley Aviation Co. said they discovered that a bottle of mercuric chloride was missing from their plant. The company uses the compound for chromium-plating tests, and last used it in February, a spokesman said.
The Bristol-Myers Co., the maker of Excedrin, began pulling all Excedrin extra-strength capsules off store shelves in Colorado and possibly some areas of neighboring states yesterday, a spokesman said, and recommended that consumers return any bottles of the capsules they now have.
In other reported poisonings, a man allegedly tried to murder an inmate at the Jasper County Jail in Missouri by giving him a candy bar injected with cyanide, police said.
In Chicago, authorities said tests have revealed cyanide and Tylenol in the body of a 21-year-old woman whose death in August was attributed to a drug overdose. Dr. Michael Schaffer, chief toxicologist for the medical examiner, said the victim had about half as much cyanide in her body as the seven persons who died of cyanide poisoning after taking Tylenol.
McNeil Consumer Products Co., maker of Tylenol, has already begun to develop a tamper-resistant container and has gone on national television with an advertising campaign in an attempt to calm consumers' fears about the product.
The medical director of McNeil says in the ad, "Tylenol has had the trust of the medical profession and 100 million Americans for over 20 years. We value that trust too much to let any individual tamper with it. We want you to continue to trust Tylenol."
The ad announced that Tylenol capsules with tamper-resistant packages will be back on the market "as quickly as possible."