Sudafed Cold Pills Recalled -- 2 Deaths Blamed On Poisoned Capsules
Once again, a common, over-the-counter medication appears to have been perverted into an uncommon kind of death.
Two Western Washington residents are dead of cyanide poisoning after ingesting Sudafed 12-Hour Cold Capsules.
Another victim is recovering from a near-death bout of cyanide poisoning. At least one other purchaser of Sudafed decongestant capsules has turned in a package that appears to have been tampered with.
Each of the four packages suspected of being tampered with was purchased at a different store, said Sue Hutchcroft, spokeswoman for the Food and Drug Administration.
They are the Fred Meyer Stores in Lakewood and Lacey, a K mart Store in Tacoma and a Drug Emporium Store in Olympia. All Sudafed 12 packages in those stores are being closely inspected by the FDA.
The manufacturer of Sudafed 12-hour Cold Capsules, Burroughs-Wellcome of Research Triangle Park, N.C., yesterday ordered a nationwide recall of the medication. Initially the recall was limited to Washington state but Burroughs-Wellcome announced the nationwide recall yesterday as ``an extreme measure of caution.''
Hutchcroft said the North Carolina plant where the medication is packaged made has been inspected and the FDA believes no tampering occurred at the facility.
The capsules are made by K.V. Pharmacuticals in St. Louis.
The dead have been identified as 40-year-old Kathleen Daneker of Tacoma and Frank McWhorter, a 44-year-old Lacey man. Jennifer Meling, 28, of Tumwater, lapsed into a coma after taking the over-the-counter medication and suffered damage to several internal organs. She is expected to recover.
``We do not know of any connection between the victims,'' Hutchcroft said. ``The only thing in common that we are aware of is that the blister packs had the same lot number, and that those lot numbers were different from those printed on the boxes.''
One of the boxes involved had a code of 8U2849, expiration date 1/91, and the other box had a code of 002847, expiration date 6/93. The foil blister pack in both cases had the same code number of 8U2846. Hutchcroft said the number on the box and on the blister pack should be identical - different numbers may indicate tampering.
Haggerty said 150,000 packages bearing the 8U2846 number were shipped, 90,000 with 8U2849 amd 145,000 with 002847.
The FBI is the lead investigating agency. Working with police in Pierce, Thurston and King counties, as well as the FDA and Burroughs-Wellcome, the FBI will pursue the deaths as possible homicides. Thousands of Sudafed 12-Hour Cold Capsules will also be confiscated and tested in FBI, FDA and Burroughs-Wellcome laboratories.
The trail of tainted medicine began Saturday, Feb. 2, when Meling became seriously ill seconds after taking a Sudafed 12-Hour Cold Capsule and a daily vitamin pill. Her husband had purchased the medicine at the Drug Emporium at 1200 Cooper Point Road in Olympia. By the following Tuesday evening, Meling said her doctor had confirmed she was suffering from cyanide poisoning. However, lab tests of the remaining capsules in the Sudafed packet failed to show any trace of the deadly poison.
On Feb. 11, Daneker died after ingesting a Sudafed 12-Hour Cold Capsule. The suspect medication was purchased at a Fred Meyer store at N. 19th Street and Stevens Street in Tacoma.
According to the Pierce County medical examiner, Daneker died after two days of hospitalization. An autopsy did not reveal any obvious cause of death.
Thurston County coroner Judy Arnold yesterday credited John Howard, a physician with the Pierce County medical examiner's office, with pursuing the possibility of cyanide poisoning. Howard had assisted with the 1986 Stella Nickell case, in which an Auburn woman was convicted of causing two deaths by putting cyanide in medication capsules.
Unable to determine a cause of death, the Pierce County medical examiner's office sent tissue samples to the state toxicology lab. Friday, results were reported indicating Daneker died of deprivation of oxygen to the brain due to cyanide poisoning.
But tests failed to find cyanide in Daneker's remaining medication, said Sharon Haggerty, a Burrows-Wellcome spokesman.
The third case of cyanide poisoning was brought to the attention of authorities late Saturday, following news reports of the recall. The wife of Frank McWhorter, a 44-year-old Lacey man, called the county coroner and said her husband collapsed after taking Sudafed Feb. 17. The cold medicine was purchased that day at the Fred Meyer store at 700 Sleater-Kinney Road in Lacey.
According to the Thurston County coroner, McWhorter remained unconscious and unresponsive until his death 26 hours later, on Feb. 18.
In McWhorter's case, however, the investigation was complicated by the fact that his organs were removed before the autopsy under a donor program.
Blood and other fluid samples drawn earlier from the man's body were taken to the state toxicology laboratory the following Sunday afternoon. Over-the-counter medications McWhorter had been taking were delivered to the FDA.
State toxicologist Logan said tests in that case will take a couple of days, but the Thurston County coroner said the man's death was consistent with cyanide poisoning.
Then, yesterday, a Tacoma-area woman returned an unused Sudafed package that showed signs of tampering to the K mart in Lakewood, a Tacoma suburb. FBI agent Dick Thurston said that ``it was obvious that the capsule was different than what was portrayed on the label.''
Dean Owen, spokesman for state Department of Health, said he's been told that the blue strip around the capsule was missing and the medicine inside was discolored.
Before returning the Sudafed to the store from which she had bought it, the customer called a Seattle radio station to express her fear that the medication might be tainted. The woman took the package to K mart, where FBI agents recovered it. Thurston said the suspect Lakewood package corresponded to the lot number for which Burroughs-Wellcome had issued warnings.
``Based on the one that was found in Tacoma today, it appears that the tampering was probably made locally,'' said Thurston.``Our initial examination would point in that direction.''
Consumers are being warned not to take the cold capsules. The FDA and the manufacturer have asked that any unused product be returned.
If a package shows signs of tampering, Thurston said consumers should contact the FBI prior to returning the medication to the store.
Saturday evening, FDA field investigators began pulling the 12-hour cold capsules off the shelves. Yesterday, retailers were pulling their stores of Sudafed 12-Hour Cold Capsules and fielding calls from nervous consumers.
Death from cyanide poisoning can be almost instantaneous, said William Robertson, director of the Seattle Poison Center.
``With cyanide poisoning, if it happened with a perfectly normal individual who immediately dropped dead, in that situation, police authorities would look for an explanation why,'' Robertson said.
``But if someone were sick and didn't give a history of it, it might take some time while they were looking around.''
Robertson said that the ``mechanism of death'' in cyanide poisoning is very similar to that of a heart attack. Robertson said that smaller doses would manifest symptoms of ``inefficient use of oxygen,'' including lack of muscle power and headaches.
The case puts Western Washington in the forefront of murders by tampering. In 1988, Stella Nickell was convicted of planting cyanide in Extra-Strength Excedrin that killed her husband, Bruce, and an unrelated Auburn bank manager, Sue Snow.
Under the federal Anti-Tampering Act, Nickell was sentenced to 270 years in prison.
In 1982, seven people in the Chicago area died after unwittingly taking Extra-Strength Tylenol capsules that had been laced with cyanide. The crime remains unsolved.
Haggerty of Burroughs-Wellcome said the company expects to receive more than a million blister packs in the recall.
WHERE TO CALL
-- Burroughs-Wellcome has set up a toll-free number for concerned consumers at 1-800-643-9500. Retailers and wholesalers may call 1-800-643-9400.
-- Consumers who think they have a tampered package of Sudafed cold capsules should call the Seattle office of the FBI at 622-0460.
Copyright (c) 1991 Seattle Times Company, All Rights Reserved.