| ASPARTAME 92 REPORTED SYMPTOMS |
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IN
A REPORT DATED APRIL 20, 1995, WRITTEN WITH THE LETTERHEAD OF THE UNITED
STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, THE REPORT ENTITLED “SYMPTOMS
ATTRIBUTED TO ASPARTAME IN COMPLAINTS SUBMITTED TO THE FDA”, THE FOLLOWING
SYMPTOMS ARE LISTED. NOTE THAT THERE ARE TWO REPORTS HERE. THE FIRST REPORT
LISTS SYMPTOMS REPORTED OVER 100 TIMES AND LUMPS THE REMAINDER TOGETHER
UNDER THE HEADING OF “SYMPTOMS REPORTED BY LESS THAN 100 COMPLAINTS”. THE
NEXT REPORT LISTS 92 SEPARATE SYMPTOMS, AS CATEGORIZED BY THE FDA ACCORDING
TO THEIR CRITERIA IN CATEGORIZING SUCH COMPLAINTS. ONE RESULT OF THIS CATALOGING
IS THAT SEIZURES – ONE MAJOR CONCERN ASSOCIATED WITH ASPARTAME CONSUMPTION,
ARE BROKEN DOWN INTO AT LEAST FIVE DIFFERENT CATEGORIES. THUS WE HAVE LISTED
291 REPORTS OF “SEIZURES AND CONVULSIONS”, 174 REPORTS OF “GRAND MAL”,
26 REPORTS OF “PETIT MAL”, 10 REPORTS OF “SIMPLE PARTIAL SEIZURES”, AND
4 REPORTS OF “COMPLEX PARTIAL SEIZURES”. THIS RAISES THE NUMBER OF REPORTS
WHICH MIGHT BE CLASSIFIED AS “SEIZURES AND CONVULSIONS” TO AT LEAST 505,
MAKING THOSE REPORTS INTO AROUND 19.4% OF THE TOTAL REPORTS FILED IN THIS
PARTICULAR COLLECTION OF COMPLAINTS.ANOTHER
NOTABLE ELEMENT IS THAT IN THE FIRST REPORT, HEADACHES ARE LISTED AS HAVING
BEEN REPORTED 1847 TIMES AND IN THE SECOND REPORT 1862 TIMES. WE DO NOT
KNOW WHAT THE EXPLANATION FOR THAT DISCREPANCY IS.
THIS
REPORT WAS GOTTEN WITH THE AID OF THE FREEDOM OF INFORMATION ACT. THE FDA
DID NOT WANT TO GIVE IT UP FREELY OR EVEN ACKNOWLEDGE ITS EXISTENCE. |
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REPORTED
SYMPTOMS |
NO.
OF COMPLAINTS |
% OF REPORTS |
%
OF COMPLAINTS |
| HEADACHE |
1847 |
21.1% |
19.0% |
DIZZINESS/POOR
EQUALIBRIUM |
735 |
11.2% |
7.5% |
CHANGE
OF MOOD |
656 |
10.0% |
6.7% |
VOMITING
OR NAUSEA |
647 |
9.8% |
6.6% |
ABDOMINAL
PAIN AND CRAMPS |
483 |
6.9% |
4.7% |
CHANGE
IN VISION |
362 |
5.5% |
3.7% |
| DIARRHEA |
330 |
5.0% |
3.4% |
SEIZURES
AND CONVULSIONS |
290 |
4.4% |
3.0% |
MEMORY
LOSS |
255 |
3.9% |
2.6% |
| FATIGUE,WEAKNESS |
242 |
3.7% |
2.5% |
OTHER
NEUROLOGICAL |
230 |
3.5% |
2.4% |
| RASH |
226 |
3.4% |
2.3% |
SLEEP
PROBLEMS |
201 |
3.1% |
2.1% |
| HIVES |
191 |
2.9% |
2.0% |
CHANGE
IN HEART RATE |
185 |
2.8% |
1.9% |
| ITCHING |
175 |
2.7% |
1.8% |
GRAN
MAL |
174 |
2.6% |
1.8% |
NUMBNESS,
TINGLING |
172 |
2.6% |
1.8% |
LOCAL
SWELLING |
114 |
1.7% |
1.2% |
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CHANGE
IN ACTIVITY LEVEL |
113 |
1.7% |
1.2% |
DIFFICULTY
BREATHING |
112 |
1.7% |
1.2% |
ORAL
SENSORY CHANGES |
108 |
1.6% |
1.1% |
CHANGE
IN MENSTRUAL PATTERN |
107 |
1.6% |
1.1% |
SYMPTOMS
REPORTED BY LESS THAN 100 COMPLAINTS |
1812 |
——– |
18.6% |
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THE
FOLLOWING IS THE COMPLETE LIST OF ALL 92 SYMPTOMS REPORTED TO THE FDA IN
1995, LISTED IN ORDER OF VOLUME OF REPORTS.
1862 28.28% 19.03% HEADACHE
737 11.19% 7.53% DIZZINESS OR PROBLEMS WITH
BALANCE
656 9.96% 6.70% CHANGE IN MOOD QUALITY
OR LEVEL
651 9.88% 6.65% VOMITING AND NAUSEA
457 6.94% 4.67% ABDOMINAL PAINS AND
CRAMPS
364 5.52% 3.72% CHANGE IN VISION
331 5.02% 3.38% DIARRHEA
291 4.42% 2.97% SEIZURES AND CONVULSIONS
256 3.88% 2.61% MEMORY LOSS
242 3.67% 2.47% FATIGUE, WEAKNESS
230 3.49% 2.35% OTHER NEUROLOGICAL
226 3.43% 2.31% RASH
201 3.05% 2.05% SLEEP PROBLEMS
191 2.90% 1.95% HIVES
186 2.82% 1.90% CHANGE IN HEART RATE
175 2.65% 1.78% ITCHING
174 2.64% 1.77% CHANGE IN SENSATION
(NUMBNESS, TINGLING)
174 2.64% 1.77% GRAND MAL
115 1.74% 1.17% LOCAL SWELLING
114 1.73% 1.16% CHANGE IN ACTIVITY
LEVEL
112 1.70% 1.24% DIFFICULTY BREATHING
108 1.64% 1.10% ORAL SENSORY CHANGES
107 1.62% 1.09% CHANGE IN MENSTRUAL
PATTERN
100 1.51% 1.02% OTHER SKIN
98 1.48% 1.00% OTHER
93 1.41% 0.95% LOCALIZED PAIN AND TENDERNESS
91 1.38% 0.93% OTHER UROGENITAL
74 1.12% 0.75% CHANGE IN BODY TEMPERATURE
74 1.03% 0.75% DIFFICULTY SWALLOWING
68 1.03% 0.69% OTHER METABOLIC
67 1.01% 0.68% JOINT AND BONE PAIN
66 1.00% 0.67% SPEECH IMPAIRMENT
59 0.89% 0.60% OTHER GASTROINTESTINAL
57 0.86% 0.58% CHEST PAIN
51 0.77% 0.52% OTHER MUSCULO-SKELETAL
50 0.75% 0.51% FAINTING
43 0.65% 0.43% SORE THROAT
43 0.65% 0.43% OTHER CARDIOVASCULAR
39 0.59% 0.39% CHANGE IN TASTE
37 0.56% 0.37% DIFFICULTY WITH URINATION
37 0.56% 0.37% OTHER RESPIRATORY
36 0.54% 0.36% EDEMA
36 0.54% 0.36% CHANGE IN HEARING
35 0.53% 0.35% ABDOMINAL SWELLING
30 0.45% 0.30% CHANGE IN SALIVA OUTPUT
30 0.45% 0.30% CHANGE IN URINE VOLUME
30 0.45% 0.30% CHANGE IN RESPIRATION
PATTERN
30 0.45% 0.30% EYE IRRITATION
30 0.45% 0.30% UNSPECIFIED
26 0.39% 0.26% MUSCLE TREMORS
26 0.39% 0.26% PETIT MAL
25 0.37% 0.25% CHANGE IN APPETITE
22 0.33% 0.22% CHANGE IN BODY WEIGHT
22 0.33% 0.22% NOCTURNAL
20 0.30% 0.20% CHANGE IN THIRST OR
WATER INTAKE
18 0.27% 0.18% UNCONSCIOUSNESS AND
COMA
18 0.27% 0.18% WHEEZING
16 0.24% 0.16% CONSTIPATION
16 0.24% 0.16% OTHER EXTREMITY PAIN
16 0.24% 0.16% PROBLEMS WITH BLEEDING
15 0.22% 0.15% UNSTEADY GAIT
15 0.22% 0.15% COUGHING
15 0.22% 0.15% BLOOD GLUCOSE DISORDERS
14 0.21% 0.14% BLOOD PRESSURE CHANGES
14 0.21% 0.14% CHANGES IN SKIN AND
NAIL COLORATION
13 0.19% 0.13% CHANGE IN HAIR OR NAILS
11 0.16% 0.11% EXCESSIVE PHLEGM PRODUCTION
10 0.15% 0.10% SINUS PROBLEMS
10 0.15% 0.10% SIMPLE PARTIAL SEIZURES
8 0.12% 0.09% HALLUCINATIONS
7 0.10% 0.07% ANY LUMPS PRESENT
6 0.09% 0.06% SHORTNESS OF BREATH OR
EXERTION
6 0.09% 0.06% EVIDENCE OF BLOOD IN
STOOL OR VOMIT
5 0.07% 0.05% DYSMENORRHEA
4 0.06% 0.04% DENTAL PROBLEMS
4 0.06% 0.04% CHANGES IN SMELL
4 0.06% 0.04% DEATH
4 0.06% 0.04% OTHER BLOOD AND LYMPHATIC
4 0.06% 0.04% ECZEMA
4 0.06% 0.04% COMPLEX PARTIAL SEIZURES
3 0.04% 0.03% SWOLLEN LYMPH NODES
3 0.04% 0.03% HEMATURIA
2 0.03% 0.02% SHORTNESS OF BREATH DUE
TO POSITION
2 0.03% 0.02% DIFFICULTIES WITH PREGNANCY
2 0.03% 0.02% (CHILDREN ONLY) DEVELOPMENTAL
RETARDATION
2 0.03% 0.02% CHANGE IN BREAST SIZE
OR TENDERNESS
1 0.01% 0.01% ANEMIA
1 0.01% 0.01% CHANGE IN SEXUAL FUNCTION
1 0.01% 0.01% SHOCK
1 0.01% 0.01% CONJUNCTIVITIS
1 0.01% 0.01% DILATING EYES
1 0.01% 0.01% FEBRILE
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