Extra-Strength Tylenol Packaging Called Among Best in Preventing Tampering With PM-Tylenol Bjt
Feb. 12, 1986
WASHINGTON (AP) _ The packaging of Extra-Strength Tylenol capsules is among the most tamper- resistant in the nation, and reveals no weakness in the nation's anti- tampering regulations, a Food and Drug Administration official says.
FDA spokesman William Grigg, speaking Tuesday in the wake of a New York investigation into poisoning of Tylenol capsules, said the Tylenol package incorporates three barriers to tampering: a cardboard box that must be ripped open to get at the bottle, a plastic neckband seal on the outside of the bottle and a foil diaphragm seal on the bottle mouth.
''It's one of the most tamper-resistant packages in existence,'' Grigg said in an interview.
Protections were added to Tylenol and other over-the-counter drug products after seven people died in a 1982 poisoning incident in Chicago. All took Tylenol capsules that apparently were dosed with cyanide while they sat on a drugstore shelf.
Authorities are now investigating the cyanide-poisoning death of a 23-year- old New York woman who took a Tylenol capsule early Saturday morning.
The body of Diane Elsroth of Peekskill, N.Y., was found about 12 hours later. Westchester County Executive Andrew O'Rourke said Ms. Elsroth was murdered by someone who placed the poison inside the Tylenol package within the last 10 days.
FDA Commissioner Dr. Frank Young said three out of 21 capsules left in the bottle were tainted with cyanide.
Homicide investigators asked the FBI on Tuesday to determine whether the cyanide was inserted before the bottle was sealed or afterwards. But FDA officials and government and industry observers said they did not believe the Yonkers death represented another case of tampering in the store.
''There's no evidence that this was the kind of random tampering on the store shelf as was the case in Chicago in 1982,'' said John T. Walden, senior vice president of the Proprietary Association, a trade group for non- prescription drug manufacturers. ''We don't have a national health and safety crisis here like we had for a time in 1982.''
He said the Yonkers case appeared to be ''a single, isolated case of poisoning.''
The assessment was echoed by Dr. Sidney M. Wolfe, head of the Ralph Nader- organized Health Research Group and a frequent critic of both the FDA and the drug industry.
Wolfe said tampering is of less concern to him than the drugs themselves. He said he wished the FDA and the drug industry would move as quickly and effectively on other drug safety issues as they had on the tampering problem.
''It's unfortunate that we have to worry about the people in our society who are deranged,'' Wolfe said. But, he added, ''I think the public should have much less reason to be concerned than they did several years ago,'' before new protections were enacted.
The Tylenol was purchased from an A&P grocery, and the chain immediately ordered its more than 1,000 stores to pull the Tylenol capsules from the shelves.
A&P ordered the recall ''as a precautionary measure,'' said Michael J. Rourke, a spokesman for the Montvale, N.J.-based company. ''If this turns out to be an isolated incident, we'll put it back on the shelves.''
Young said Tuesday that consumers in the New York area should avoid taking Tylenol capsules, and people nationally should not take Tylenol from the batch in question. He said people need not be concerned about Tylenol tablets or other Tylenol medication.
Johnson & Johnson, the New Brunswick, N.J.-based manufacturer of Tylenol, said the batch in question bears the coding ADF916 and a May 1987 expiration date.
Grigg said examination of other bottles from the A&P showed no signs of tampering. No cyanide has been found and no tampering has been reported from other bottles in the batch, Grigg noted, although the batch has been on store shelves since last August.
He said Young's warning to avoid Tylenol from the designated batch was a routine precaution and indicated no special concern about the Tylenol manufacturing process.