News
03/22/1990

<TITLE>Recall of L-Tryptophan</TITLE>
<PRE>
Recall of L-Tryptophan


P90-21                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Chris Lecos - (202) 245-1144

    The Food and Drug Administration today expanded its recall of 
L-tryptophan to include even small dosages of the manufactured dietary
supplements.  The agency said reports of the newly recognized disorder
eosinophilia-myalgia syndrome, or EMS -- which has been linked to these 
products -- have climbed to 1,411, with 19 deaths.
    Until now, the recall has involved manufactured L-tryptophan products 
that, taken as directed, would result in a daily intake of 100 or more
milligrams of the amino acid.  But FDA today requested that manufacturers 
expand the recall to products at any dosage.
    HHS Secretary Louis W. Sullivan, M.D.,  said, "We are confronted with a 
major public health problem."  He warned, "EMS can cripple.  It can cause 
great pain.  It can kill.  It has had long-term effects on some unfortunate 
individuals, and some patients are not responding to treatment.  I urge 
everyone to stop taking these supplements immediately." 
    Dr. Sullivan said the rate of illnesses has been dramatically slowed by 
the Nov. 17 recall initiated by FDA, "but some recent victims have apparently 
continued using L-tryptophan products since the recall began."
                                   


                                                         Page 2 
    The recall applies to all L-tryptophan products in tablet, capsule, 
caplet, powdered or liquid form, along with multi-ingredient, non-protein 
supplements that also contain L-tryptophan. 
    Today's action follows a reassessment of the ongoing investigation by the 
FDA's Health Hazard Evaluation Board, a body of scientists within FDA's 
Center for Food Safety and Applied Nutrition, which advised that "the risk of 
contracting EMS due to the consumption of any dietary L-tryptophan product
far outweighs any perceived benefit that may be derived from the continued
marketing of this product in any dosage form..."
    FDA's Nov. 17 recall was based on evidence from the U.S. Centers for
Disease Control in Atlanta and state public health agencies that EMS victims
had intakes of L-tryptophan that ranged from 150 to 17,000 milligrams a day.
The majority were consuming 1,000 to 2,000 milligrams daily.  But there is
now at least one EMS case where the individual's intake level was reportedly
below 100 milligrams. 
    At the time of the November recall, 287 illnesses and four deaths had 
been reported to CDC.  "These numbers have increased every week since then, 
and there are now EMS cases in every state," Dr. Sullivan noted.
    The investigations so far have failed to link the illness to a single 
lot, brand, manufacturer or supplier of L-tryptophan.  Nor have the 
investigations identified any chemical or microbial contaminant in
L-tryptophan preparations that could be responsible for the outbreak. 
    Because natural L-tryptophan is present at low levels in some foods, many 
people assumed the manufactured products were safe and have taken 
L-tryptophan supplements for insomnia, premenstrual syndrome, stress
                                   


                                                           Page 3 
    reduction and other uses.  Such uses were largely spread by word of 
mouth.  None of the uses has been approved by FDA.
    According to CDC and its Jan. 15, 1990, "interim guidance" to physicians
published in the Annals of Internal Medicine, victims of EMS typically
complain of myalgia -- severe muscle pain -- and fatigue.  The myalgia can be 
very intense and often is incapacitating. 
    Many patients suffer breathing difficulties, cough, skin rashes of
varying severity, swelling of the extremities, muscle weakness, and fever.
Not everyone is affected the same way.  Some symptoms disappear while others
persist or reappear.  In some instances, patients display signs of congestive 
heart failure and paralysis.
    Blood tests disclose high levels of eosinophils, a type of white blood
cell.  These counts can range from 1,000 to more than 32,000 eosinophils per
cubic millimeter of blood.  A normal eosinophil count should be below 500.
    Some patients develop potentially fatal ascending polyneuropathy -- a 
condition involving gradual progressive weakness, sometimes to the point of 
complete paralysis. 
    Dr. Sullivan said people who have taken L-tryptophan and experience 
symptoms should contact their physician immediately.
    The only products not subject to today's recall are some protein
supplements, infant formulas and special dietary foods, intravenous and oral
solutions, in which small amounts of L-tryptophan are needed for nutrient 
fortification.  There have been no reported cases of EMS associated with
these products. 
</PRE>