Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: FRIDAY, March 23, 1990 TAG: 9003232813
SECTION: NATIONAL/INTERNATIONAL PAGE: A/5 EDITION: EVENING
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
They have found no contaminant or bad batch of raw material, no single brand that seems to be the culprit.
"We have analyzed hundreds of products, but we have not been able to single out any brand, manufacturer or supplier that would explain why people are getting sick from taking this stuff," said Chris Lecos, a spokesman for the Food and Drug Administration.
Even so, the FDA announced Thursday that it was expanding its recall of L-tryptophan supplements to include products that contain even small amounts of it.
The initial recall, announced last Nov. 17, was for supplements in which L-tryptophan was the sole or major component and would provide a daily intake of more than 100 milligrams.
But now at least one case has been reported in which the person developed the newly recognized blood disorder after taking less than 100 milligrams a day.
The disorder is called eosinophilia-myalgia syndrome, or EMS. So far, 1,411 cases have been reported in all states, including 19 deaths.
EMS is marked by severe muscle and joint pain, breathing difficulties, swelling of the arms and legs, skin rash, fatigue, cough and sometimes fever. In some cases, victims show signs of congestive heart failure or develop a condition that causes progressive weakness and sometimes leads to paralysis.
L-tryptophan, an amino acid, has been around for many years and occurs naturally in some foods, including milk, beef, turkey and beans.
L-tryptophan supplements are usually sold over the counter in health food, drug and grocery stores under different brand names. They are taken for insomnia, appetite control, depression, premenstrual syndrome, stress reduction and other problems.
"There are literally hundreds of brands involved here with various levels of L-tryptophan in them," the FDA's Lecos said.
In a typical recall, the FDA knows who made the product, how much was produced and where and when it was distributed.
"But here's a situation where the only unequivocal fact is that people who come down with EMS are people taking L-tryptophan before they became ill," he said. "As our investigation has continued, we have discovered that many of these people were taking not just one brand, but six or more brands."
The expanded recall applies to all L-tryptophan products in tablet, capsule, caplet, powdered or liquid form, as well multi-ingredient, non-protein supplements that contain L-tryptophan, the FDA said.
The only products containing L-tryptophan not being recalled are some protein supplements, infant formulas and special dietary foods, intravenous and oral solutions, in which small amounts of L-tryptophan are needed for nutrition fortification, the FDA said.
No cases of EMS have been linked to any of those uses, the agency said.
However, it was not clear whether certain products like diet and body-building supplements containing L-tryptophan would have to be recalled. Some of these are formulated according to FDA regulations, but others are not.
by CNB