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Ephedrine Alkaloids Summary of Incidents
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Dated: April 22, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
Donna E. Shalala,
Secretary of Health and Human Services.
Note: The following Appendix will not appear in the annual Code of Federal Regulations.
Appendix--AER's Associated With Ephedrine Alkaloid-Containing Dietary Supplements

ARMS No.
Product manufacturer
Clinical summary
9101
Thermojetics Herbal Tablets-Green
Herbalife International.
33 yo F used product (bid, ?dose) in 11/93 until 1st week in 1/94, when she started having dizzy spells that progressed to involve numbness of L arm & forehead, weakness of both legs, SOB, and shaky feelings. 1/30/94 seen in ER for dizziness & tachycardia, Dx labyrinthitis, Tx Valium, d/c on Antivert. 2/2/94 episodes worsened, including dizziness, severe tachycardia, and SOB. She was transported to hospital & admitted w/extensive w/u (CAT, XR echo, doppler, halter, labs). D/c on 2/8 on Tenormin and Ativan w/Dx of SVT. Normal PE in 10/93. No h/o allergies or CV disease. Mother (insomnia) & husband (blood in stool) using product w/various SSx. Sister took product w/o problems.
9316
E'OLA AMP II Pro Drops--E'OLA
23 yo F hospitalized w/ cardiac arrest, CPR, then Bio-genics, Inc. ICU. Dx inferolat MI. CK > 2000 (MB+), EKG: sinus tachy & <u-arrow>ST inf leads; angio: lacerated coronary (partial dissection) & hematoma at bifurcation of circumflex artery. Used AMP II 3-4 drops in beverage night before arrest, also noted to be using other `diet pills' (?dose/durations). Drug screen negative, doing well off product.
9552
Nature's Nutrition Formula One
35 yo F good health, no risk factors for CAD used Affiliated Consultants Inter./ product 04/94--05/94 (30 days) for WL&E, as much Alliance U.S.A. Inc. as 1-2 caps bid 30 days. She stopped for a week but resumed again at 3 caps qd. On 6/25/94, developed acute onset of throbbing, ant. CP at rest, w/ pain radiation to the left shoulder, numbness of left arm & hand, diaphoresis and SOB. The pain persisted, and she was taken to the ER. The pain decreased with subl nitro and was completely relieved with morphine and nitro. On admission, BP: 140/100, EKG: minor ST depressions V<INF>1, V<INF>2, and minor ST elevation in INF leads, elevated cardiac enzymes. Dx: Acute non-Q wave MI probably secondary to coronary spasm. Cardiac cath 6/27/94 LV angiogram very mild posterior basilar hypokinesis, normal LV function w/ good ejection fraction. Normal coronary arteries. Discharged after 4 days on Cardizem, aspirin, nitro prn, & f/ u for a limited stress test.
9747 Ripped Fuel--Twin Laboratories 40 yo F reported by physician to suffer a grand mal Inc. seizure after using product for 3 days (2 bid) as directed. Her husband stated she stopped breathing and he had to administer mouth to mouth
resuscitation. She was on no medication and had no personal nor family history of seizures. She had no symptoms until she felt dizzy immediately before her seizure. CT head--no abnormalities.
9751 Slim NRG--Momentum Marketing 28 yo F (weighing 95 lb) reported by MD. Used product, 1 tid for 6 months for weight loss (30 lb). Stopped product abruptly, became despondent over 10 days ending w/attempted suicide--gunshot wound to chest. No other products used. Past mental history negative for mental illness, use of drugs/alcohol. Drug/ETOH screen neg. Tx: w/ antidepressants. Positive dechallenge.
9754 Shape-Fast--Shaperite Concepts 44 yo F reported by physician's assistant to be Ltd. taking product (400 mg bid) when she developed heat stroke, chest and back pain, hyperthermia and tachycardia while exercising.
9818 Power Trim--Enrich 43 yo M who used product (details not given) over a International. 6 wk period and lost 30 lb., developed new onset insomnia and atrial fibrillation. Seen by health care provider and given Lanoxin, hospitalized next day when light headedness developed. Extensive w/u (EKG, CXR, echo-cardiogram, smac, myocardial enzymes), compatible with AF. Dx: ``new onset atrial fibrillation, possibly due to the stimulant effect of his dietary supplement.'' Tx: Lanoxin, Betapace, Verapamil, and Coumadin.
9864 Nature's Nutrition--Formula 44 yo M, active swimmer and tennis player, with no One--Affiliated Consultants known cardiovascular risks as documented by Intl/Alliance U.S.A. medical history, originally obtained a sample of product during a routine physical from his health care provider when he requested some substitute for his daily coffee and cocoa use. He used this product as directed, and was able to eliminate his afternoon coffee/cocoa use. On 12/18/93 (3 weeks after starting product), after playing his routine weekly game of tennis, he came home, laid down and was found dead about noon. Resuscitative efforts were unsuccessful. Autopsy revealed an acute thrombus, 1.5 cm from the origin of the left anterior descending coronary artery, resulting in occlusion. All lumina were otherwise patent, although calcification of the coronary arteries resulting in focal narrowing to about 50 percent was noted. A drug screen performed at the time of autopsy was reportedly negative for amines.
10009 MetaboLift Thermogenic--Twin 35 yo M w/acute MI (inferoapical). Took product Laboratories, Inc. (two capsules at noon and 3 capsules at 4:30 PM) Worked out 5:30 PM--6:30 PM and developed chest pain around 7:30 PM. Consumer admitted, treated w/ TPA, subsequent cardiac catheterization
demonstrated normal coronaries. CPK elevated, EKG diagnostic for MI.
10026 Formula One--Affiliated 48 yo F took product (3 caps qd) for 6-7 months Consultants Intl./Alliance when developed weakness, syncopal episode, U.S.A. increased BP, increased HR, tightness in chest. Seen in ER w/EKG which showed nonspecific STT wave abnormality, and increased cardiac enzymes. BP-120/ 99. Saw MD next day, complained of right sided weakness and speech difficulty. Meds:
antihypertensives, hormones. Dx: ``conversion reaction'', thought to be stress related. Sxs improved over next month. MD later told about use of product, which he states could aggravate nervousness.
10063 Super Diet Max--KAL, Inc 22 yo F had been using product several months at 1 tab bid for WL. On day of adverse event she had taken 2 caps (1 q AM, 1 q PM), and experienced increased BP, pounding heart, n/v, lasting 1.5-2 hr. Event abated after product discontinued. Saw health care provider. Started on Prozac 2 wks prior to adverse event.
10088 Nature's Sunshine SN-X 100 38 yo F took product for 4 days and developed Vegitabs--Nature's Sunshine. syncope, blood pressure = 180/110. Seen in ER with severe HA, nausea, diaphoresis. The consumer had been seen every 3-4 months for 5 years prior to this event and no history of high blood pressure. After stopping the product her blood pressure returned to normal.
10275 Nature's Nutrition Formula One 63 yo F reports using product for 3 weeks at Affiliated Consultants recommended dose, never used maximum recommended International/Alliance U.S.A. dose, when she developed hives. The next day she had difficulty walking across room, difficulty breathing and swallowing, and vomited. She suffered ventricular fibrillation, a small non Q- wave infarct by enzymes criteria and was hospitalized 5 days where evaluation (cardiac catheterization, electrophysiology study) failed to find any sort of heart problem or heart disease to explain her arrest. She has chronic obstructive pulmonary disease secondary to cigarette smoking. Previous to arrest no medicine and only vitamin and occasional aspirin.
10437 Thermojetics Herbal Tablets 55 yo F reports grand mal seizure after 3 days on Beige, Thermojetics Herbal product per directions. No significant past Tablets--Green, Formula 1, history, normal CT and EEG. No meds or other Formula 2, Formula 3-- dietary supplement products. Herbalife International.
10862 Ultimate Xphoria--Alternative 20 yo M took 8 tabs @ 4 pm (directions: Take 4 Health Research. tablets, on an empty stomach; do not exceed 4 tablets in 24 hours). Within 30 minutes, complained of being hot, w/ sweating & HA. Found dead by friends 8 hr later. Coroner's report notes toxic levels of ephedrines.
10919 Power Trim--Enriched 9 yo F used Power Trim, 3 capsules three times International. daily for 3 weeks for weight loss. She developed weakness, dizziness, nausea, vomiting, and palpitations and went to the ER where she was found to have vertigo, serous otitis media bilaterally, hypertension (150/102) and elevated liver enzymes. The consumer reports stopping the product and her blood pressure has returned to normal without any medical treatment. She has no history of high blood pressure.
10943 Multi DS 37 yo F used for 1 week, (1) Omnitrim Tea, 2 teaspoons (2) Omni 4--Omnitrition three times per day, and Omni 4 (a vitamin) one International, Inc. daily, both as directed, for weight loss. She stopped due to the development of shakes, sweats, dizziness, racing heart, and loss of hearing in R ear. Symptoms abated after stopping product. No other products in use and no significant medical history.
10946 Multi DS (1) ThermoChrome 42 yo F used Thermochrome 5000, 1 capsule twice 5000, (2) Isotonic Vitamin daily for 3 days for weight loss. She was also B12, & (3) Isotonic OPC3 (1) taking B12 and an antioxidant supplement. She Health Power Products Inc./ developed a rash over her entire body and stopped Market America; (2) & (3)-- all three products. She restarted the Thermochrome Labels unavailable. 5000 after 3 days and 3 days after that, on a visit to her doctor for a nonproductive cough and congestion, was found to be hypertensive (170/ 114). She has no history of hypertension and was seen by her gynecologist 1 week before starting the Thermochrome with a normal blood pressure (120/ 78).
10957 E'Ola Amp II Pro Drops--E'OLA 34 yo F used E'Ola AMP II Pro Drops according to Bio-genics, Inc. label directions, off and on over a 2 year period for weight loss. She developed ``triple vision'' which lasted a few moments and recurred 3 days later accompanied by vertigo. She was initially seen in an ER, where examination and CT were normal and she was diagnosed with dehydration. She spent 3 days in bed with severe vertigo, nausea, and vomiting. She was unable to reach out and pick up a drinking glass. An MRI showed multiple bilateral cerebellar infarcts. No source of embolization was identified. Cardiovascular, autoimmune, and coagulopathy workups were unremarkable.
10960 Blast and Burn--Vita Labs Inc. 16 yo F used Blast and Burn as directed on the package for several weeks for performance as a high school athlete. Within the first week of use she was taken to the ER with a racing heart. She had several similar episodes. She couldn't afford to buy a second bottle of the product and noticed her symptoms resolved once she stopped using the product.
10974 ShapeFast--Shaperite Concepts 19 yo F took Shaperite, one before each meal, three Ltd. times per day (\1/2\ of recommended amount) for 1 month, for weight loss. Her family witnessed seizure activity at mealtime and took her to the ER. CT and EEG were normal. Neurologist's evaluation found no other risk factors for seizure. No other products used, no significant past history noted.
10977 Emphora Ecstasy--Label 18 yo F took Emphora Ecstasy, 4 pills at once, to unavailable. get high. About 2 hours later she noted dizziness, racing heart and felt she would pass out if she stood up. She was unable to sleep for most of that night. The next morning she passed out in the shower, injuring her neck and back. She went to the ER where the only abnormality noted was a low potassium of 3.1 meq/L (normal 3.6-5.2). She has had dizziness in the past but no previous loss of consciousness. The product was not used again and her symptoms resolved.
10989 Herbal Ecstasy--Label 18 yo F used Herbal Ecstasy, 5 pills at once, one unavailable. time as directed to get high at a Lolapalooza concert. She felt ``numb, weird'' and fell backwards. She was unable to sleep for 3 nights in a row. Over the next 8 months, she had difficulty sleeping, refused to leave the house unless her parents insisted and did not attend college as planned in the fall. She has been diagnosed with panic attacks and depression and is currently under psychiatric treatment. She has also been diagnosed with a ``weak heart valve.''
10990 Tri-Chromaleane--Achievers 58 yo M used Tri-Chromaleane, 3 pills once daily Unlimited. for 6 weeks for weight loss. He developed memory problems. He couldn't remember his son's middle name, his office phone number or how to get home from a local store. He would start work and be unable to remember why he had started the task or what to do next. He stopped the product and his symptoms resolved over the next 2 weeks. At the same time he had been participating in a clinical trial of Proscar for the prevention of prostate cancer and does not know whether he had been taking Proscar or placebo. The Proscar study coordinator reported that it was unlikely that the consumer's complaints were related to Proscar. Of note, he never had prostate cancer.
10991 Tri-Chromaleane--Achievers 54 yo F used Tri-Chromaleane, at less than the Unlimited. recommended amount, once daily for a number of weeks. She was under treatment for hypertension and was told by the distributor that the product would lower her blood pressure. After starting the product her blood pressure increased and her doctor added a second medication and her blood pressure improved. She was unable to pass an insurance physical due to her inadequately controlled high blood pressure. She stopped the Tri-Chromaleane and her blood pressure has improved to the point that her doctor is planning to stop the second blood pressure medication to see if she can be controlled on a single medication (as she was before using the Tri- Chromaleane).
11050 ThermoChrome 5000--Health Power 63 yo F took 2-3 pills bid, for 2 months for weight Products. loss. She was taking Lescol for hypercholesterolemia, Zantac for esophageal reflux and Vasotec for hypertension. She developed worsening of her hypertension (174/93) and episodes of palpitations. She sought medical assistance from a neighbor who is a physician after an especially severe episode of palpitations. After stopping products BP normalized (140/80) and palpitations resolved.
11062 Power Trim--Enrich 2 yo F used 2-3 caps before meals tid as directed International. for 3 months for weight loss. She was taken to hospital by ambulance after family members found her seizing. She had another seizure while being examined by neurologist. She complained of increased headaches and slow thinking in the days preceding her stroke and was taking penicillin for a dental abscess. CT and MRI showed a small R- sided intracerebral hemorrhage. MRI and
angiography revealed no evidence of any vascular abnormality. She was treated with Dilantin.
11065 Thermo Slim--Weight Loss 23 yo F used product, 1 tab before meals 3 times Specialist. per day with The Accelerator Guarana, 1 tab before AM and noon meals, for 8 days. On the 9th day she forgot to take her noontime dose. At first she thought she might be going into withdrawal, took another dose and vomited shortly afterwards. She was taken to the ER with complaints of a racing heart, dizziness, numbness of face and arms, and disorientation. The doctor advised her to stop the products and over the next week her symptoms resolved.
11078 Formula One with Quick Start 36 yo F used Formula One for 2 yrs, stopped that Alliance U.S.A. product and then took Quick Start 2 caps which she used once. The next morning she experienced grand mal seizures. She was taking 2 iron tablets, Ionamin 30 (a dietary supplement) and B12 liquid; also had switched to the night shift. CT, MRI, and EEG were normal.
11081 Herbal Ecstacy--Label M used Herbal Ecstacy, 10 pills once, to get high. unavailable. He states he became ``psycho,'' very active, developed a ``bad mood'' and assaulted a friend. His symptoms resolved and he did not try the product again.
11105 Trim Easy--TeamUp International 31 yo F used Trim Easy for about 1 year for weight Inc. loss. She originally used 2 capsules three times daily for 1 month and then increased to 3 capsules three times daily (9 total). The directions advised beginning at 2 capsules three times per day and increasing if tolerated to 3 capsules three times per day, the maximum recommended dose. At times she would forget one of the 3 doses and double up the next time she took the product (6 capsules at once). She continued to take a total of 9 capsules this way daily for about 3 months and then decreased to a total of 6 capsules taken all at once each day for about 8 months. She developed dizzy spells which increased over 1 month's time to twice daily and eventually suffered a stroke--an intracerebral hemorrhage with Lft hemiparesis and aphasia. CT and MRI documented the bleed, showing midline shift. Cerebral angiogram did not show any additional abnormality such as an arteriovenous malformation.
11106 Therma Slim--Great American 47 yo F used 1 pill at breakfast and 1 at lunch for Products. 2 months. She developed profuse sweating, trembling and HTN, and menstrual bleeding which lasted 6 wks. She was treated first with Megesterol and then with Premarin and Provera, by gynecologist. It was also noted that her BP had risen from 110/70 (3/18/96) to 156/98 (4/10/96). She complained to radio station where she originally heard about product and received a letter telling her side effects she was
experiencing were normal and would quickly subside. 4/11/96--Consumer contacted her HMO after seeing broadcast on ephedra and was advised to stop using product. 6/1/96--This consumer later suffered a pontine stroke and requires an endotracheal tube and feeding tube for long-term ventilatory and nutritional support, respectively. Estrogen use was implicated as a possible contributing factor by health care provider.
11107 Diet Fuel--Twin Laboratories 42 yo M used Diet Fuel, 3 pills daily for 9 months. Inc. He became dizzy, nauseated, developed left sided chest pain, passed out in a meeting. Paramedics noted his pulse to be in the 30's and he was hospitalized. After cardiology evaluation and electrophysiologic studies it was concluded that the consumer had an abnormal vasodepressor response to tilt plus catecholamine administration and was placed on Tenormin. The consumer reports a similar episode many years prior and as a young man treated with Dilantin for what was diagnosed as epilepsy.
11109 Unspecified E'OLA product 46 yo F used two E'OLA products, an energy product, E'OLA Bio-genics, Inc. 2 drops twice daily, and a metabolism booster, 4-5 drops twice daily, both for 1\1/2\ weeks, for energy and weight loss. She developed a heart rate of 200 beats per minute and sought medical attention. Medical records describe evaluation for recurrent paroxysmal palpitations for 20 years. No mention of the use of E'Ola products. Blood pressure, pulse, EKG, echocardiogram, exercise stress test failed to reveal an underlying cardiac disorder.
11112 Thinner Jizer--Quiet Storm 34 yo F used Thinner Jizer 1 pill for 1 day, 1 pill twice daily, then 2 pills in AM and 1 pill in PM, increasing as directed. After 3 days on the highest amount (2 pills AM and 1 pill PM) she developed jitters and was advised by the distributor to cut back the dose as this response was normal. She used 1 pill AM and 1 pill PM for an additional 3 days when she developed acute visual changes in her right eye lasting 25 minutes. She sought medical care and was advised that her symptoms were likely due to vascular spasm, possibly related to her use of ephedra. She stopped the product, took aspirin for 1 week and has had no further episodes of acute visual changes. She was taking no other products and has no significant prior history.
11114 Herbal Ecstacy--Label 16 yo M used Herbal Ecstacy, 2 pills one time. Half unavailable. an hour later he found himself driving down the wrong side of a road and didn't realize it until he saw a car headed towards him. He described feeling ``a major rush, tingly, hyper.'' He denies taking other products including drugs, alcohol, or street-type drugs at the time. He occasionally uses ginkgo biloba, but had not taken any that day.
11131 Multi DS (1) Herbal Ecstacy & 20 yo M used Herbal Ecstacy, 5 pills one time as (2) Nirvana--(1) Global World directed, for recreational purposes. He also took Media & (2) Label unavailable. 6 Nirvana pills one time (directions recommend 7 pills) also for recreational purposes. He went to a club and began to feel dizzy, lightheaded and nauseous. He noted stomach cramps, thirst, and a ``real bad headache.'' His symptoms forced him to leave the dance floor, feeling he was going to pass out. He fell on his knees, started ``seeing things'' and felt his seeing and hearing were distorted. He noted shortness of breath, sleeplessness, and hives. His symptoms resolved by the next day. He denies alcohol, other drug or product use that night.
11134 Multi DS (1) Ripped Fuel, (2) 23 yo M college student who used multiple dietary The Ultimate Whey Designer supplements for approximately 2 years with Protein, (3) Super Amino 2000, observed daily use during the year prior to being (4) Super Once-A-Day Timed found dead at home by his sister. There was no Release Multiple Vitamins and previous medical history and no evidence of trauma Chelated Minerals--(1) Twin or substance abuse. Toxicology screens were Laboratories, Inc. (2) Next negative for alcohol, barbiturates, cocaine, Nutrition Inc. (3) Ultimate methamphetamine, morphine, and salicylate but Nutrition Products Inc. (4) indicated the presence of ephedrine alkaloids in Quest Vitamins LTD. the urine. The Medical Examiner's reports states the cause of death as, ``patchy necrosis associated with ephedrine toxicity from protein drink containing ma huang extract.'' Review of health examination reports from the University Health Service indicate the consumer was in excellent health with normal weight, height, blood pressure, and laboratory measurements.
11137 Natural Trim--Starlight 9 yo F used product for 6.5 months, 1 thermogenic International. pill, 1 vitamin and 1 booster pill at 10 AM, and 1 thermogenic pill at 4 PM, as directed. While on antibiotics for a sore throat, she developed upset stomach and stopped the products. She became shaky, weak, and exhausted, and felt as if she were about to pass out if she tilted her head. She was diagnosed with hyperthyroidism. She also reports her supplier has stopped selling the product as the seller has suffered seizures.
11140 Power Trim--Enrich 59 yo F used Power Trim and later Power Prime and International. has had a total of 3 vertigo attacks: 2/96, 4/96, and the third at an unspecified time. She has been to the ER and seen her physician.
11144 Metabolift--Twin Laboratories 28 yo M used Metabolift for 10 months, 1 cap 1-2 Inc.. times daily for energy. While visiting a rental property with his father's truck, his father had found him bloody, walking away from the garage, and responding inappropriately. He has transient retrograde amnesia. In the emergency room his blood pressure was 168/90, and pulse was 116. CT head EKG were normal. He was diagnosed with syncope and a closed head injury. The next week the consumer had an EEG, echocardiogram, and MRI of the head--all normal. His neurologist stated ``most likely he had a seizure secondary to the ephedrine'' from the health food substance he was taking. He was advised to avoid the product and dispose of it. He was on no other medication, has no significant past medical history and has never had problems with dizziness or passing out.
11180 Nature's Nutrition Formula One 41 yo F used Nature's Nutrition Formula One Alliance U.S.A. Inc. (Alliance) 1-2 pills in AM and 1-2 pills PM for about 6 months for energy. One morning she took 2 pills, skipped breakfast and drank a diet Pepsi. Soon after she developed hives while visiting a nursing home and was given benadryl tablets. Two hours after taking the Formula One she was found unconscious in a stairwell by nursing personnel who described seizure activity. She was taken to an ER where the evaluation including EEG and CT scan was normal. She has not used the product again and has had no further episodes.
11181 Multi DS (1) Ripped Fuel & (2) 19 yo M used Ripped Fuel 2 pills 2-3 times daily, Unspecified chromium according to label directions, for 2 days for picolinate with caffeine weight-loss and body-building. He was found by product--(1) Twin family members on the morning of the third day, in Laboratories, Inc., (2) GNC. his bed with seizure activity and afterward complained of dizziness and a headache. He was taken to the ER and given IV Dilantin. CT and MRI were normal and EEG was nonparoxysmal. He had also been taking chromium picolinate, 1 pill daily as directed for 3-4 months; Phosphagen, 1 teaspoon with meals, three times per day as directed for 3- 4 months; and B2G vanadyl sulfate, 2 capsules with meals, three times per day, as directed for 1 month at the time of the event. Based upon the test results and history of use of the Ripped Fuel, his neurologist felt the patient did not need to be treated with Dilantin. The neurologist advised the patient to stop use of all ``over-the- counter medications''. The patient suffered a second witnessed seizure 1 month later and was started on Dilantin. His past history is significant for a concussion as a child with a normal CT at the time.
11215 Ripped Fuel 24 yo M used Ripped Fuel, 2 tablets three times Ripped Force--Label daily for 2 years and Ripped Force, 1 bottle daily unavailable. for 2 months. He used both products for body building. He went on vacation, stopped the products and within 3 days experienced 2 grand mal seizures. The second seizure was witnessed by the ambulance crew while en route to the ER. MRI of head and EEG were both reportedly normal. He was also using `vanadyl', creatine, and amino acids as part of his body building regimen. He denied use of recreational drugs, medications, or other products.
11248 Multi DS (1) Formula One, (2) Equilizer, 37 yo M used products 2 yr (and had used other (3) Protein Plus Chromium products containing ephedrine prior to use of Picolinate, (4) Fast Start-- Formula One). (Formula One use: 1-2 cap mid AM & (1) Alliance U.S.A., Inc, (2), PM, per label instructions). Also known to consume (3), (4) Equinox Intl. large amount of diet cola. Experienced apparent sudden cardiac arrest, with no details known surrounding death. Coroner's report notes: cardiomegaly w/mild LVH, focal interstitial fibrosis & mild medial hypertrophy. PMH: neg for HTN. Tox screen noted pseudoephedrine in urine.
11249 Victory Turbo Pump--Joe Wider 20 yo M took product for 3 months (once or twice Nutrition. per week), experienced grand mal seizure. Neg. past history and family history for seizure disorders. He was treated with Dilantin.
11286 Breathe Easy Herbal Tea 36 yo F used Breathe Easy Herbal Tea on one Traditional Medicinals. occasion at less than recommended dose. She steeped tea for 1 minute and drank \1/3\ cup instead of steeping tea for 5 min as indicated on the instructions. She used product along with 2 Advil to relieve cold/congestion symptoms. Approximately 15 min after drinking tea she experienced rapid, pounding heartbeat. Following advice of friend who is a nurse, she drank large amounts of water in effort to ``flush tea out of her system.'' She felt so bad she could hardly get out of bed, but did not seek medical care secondary to anxiety about hospitals. Symptoms resolved completely within 5 hours. Routine medical visit approx 1 month after event was unremarkable. Past medical history is significant for occasional palpitations. Consumer's husband used product on several occasions prior to event with no report of negative side effects.
11298 Multi DS (1) Fast Start-The Equilizer, 41 yo M used 3 herbal products as directed on (2) Nigh Time, (3) Protein labels in an attempt to lose weight. He Plus, Chromemate--Equinox experienced a ``rush'', and blurred vision which International. influenced his ability to operate heavy equipment. On 5th day of using the product, his underwear was noted to be stained red. A physician visit confirmed hematuria, and noted BP of 136/102, and labs: SGPT 72, cholesterol 208, triglycerides 401. He stopped the product, with recovery, including normalization of BP.
11401 Ultra Energy Now--Phoenix 42 yo M used Energy Now tablets on 2 separate Health Products. occasions. He took 3 tablets as instructed on label on both occasions. First occasion was without incident. 2 weeks later when he used product for second time, he experienced severe diaphoresis, blurred vision, SOB, lightheadedness, and pounding chest pain within 1 hour of taking product. Symptoms lasted approx 15 min and had resolved completely by the time he was seen in emergency room. He was admitted to hospital overnight for evaluation including EKG, CBC, & SMA- 18 which was all within normal limits. Of note, he was not using any other products. History is significant only for positive tobacco history=1.5 pack of cigarettes per day.
11417 Thermojetics Herbal Tablets 34 yo F died following diagnosis of primary Green--Herbalife International. pulmonary hypertension (PPH). Mother of deceased found bottles of Herbalife Green & Beige tablets in home of the deceased. Duration and detail of use are unknown. Deceased appeared to be in excellent health until approx. 3 months prior to her death when she developed SOB & n/v while skiing in Colorado despite numerous previous ski trips in same location which were uneventful. She was diagnosed with ``high altitude sickness.'' Symptoms persisted and she subsequently underwent cardiac catheterization 3 months after onset of sxs. Results of cath were apparently consistent with PPH and indicated that she would need heart/ lung transplant in 3-5 years. She died 3 days later in August 94. Past medical history is significant only for hospital admission 1 year prior to death for CP, SOB, and possible pneumonia.
11441 Ripped Fuel--Twin Laboratories 27 yo M died secondary to injuries sustained in Inc. motor vehicle accident. Wife of deceased reports he had been taking Ripped Fuel 2 tabs bid as instructed on label for approx. 3 years prior to death. No autopsy was performed. Post mortem blood analysis indicate: 0.05 percent ethyl alcohol & 0.31 percent mg/L phentermine. Post mortem urine analysis: Positive for phentermine, negative for cocaine, opiates, benzodiazepine, cannabinoids.
11442 Thermojetics Herbal Tablets 39 yo F used Herbalife Diet Plan which consisted of Green--Herbalife International. the following 5 products: Formula 1 Protein Drink Mix (2 tablespoon bid); Formula 2 Multivitamin- Mineral Tablet (1 tablet tid); Formula 3 Cell Activator Capsules (2 capsule bid); Herbal Beige Tablet (1 tablet bid); Herbal Green Tablet (3 tablet bid) all taken as directed on label. No other products were being used at the time she developed the adverse events. 3-4 months after starting plan, she began experiencing blurred vision and headache. 2 weeks later she began experiencing dizziness, lightheadedness, slurred speech, and numbness on right side of her body. Evaluation by neurologist indicated patchy sensory deficit in right leg, most pronounced in foot. MRI of brain showed findings consistent with recent hemorrhage associated with cavernous malformation. Evaluation by internist indicated negative w/u for Lyme disease and no additional significant findings. Symptoms improved after consumer discontined use of products.
11619 AMP II Drops--E'OLA Bio-genics 35 yo F used Liquithin & AMP II Pro (both 7 drops Inc. bid) and Citrin Trim (2 tablet/day) for 1 day and developed migraine headache which she typically experiences every month. She awoke at 3 AM on morning after using products with notable right sided facial weakness, CP, palpitations, right arm weakness and numbness, photophobia, and unsteady gait. She was seen by doctor and admitted to hospital. Symptoms improved during hospitalization which was uneventful. All test results were within normal limits except cerebral arteriogram findings which suggested mycotic aneurysmal change or possible changes secondary to an unusual drug induced vasculitis or collagen vascular disease. Discharge dxs included: right facial and arm weakness, cause uncertain; improving right eye irritation; resolving headache; resolved chest pain & palpitations with neg w/u; and history of right C5-6 cervical radiculopathy, carpal tunnel syndrome. Sxs continued to improve in month following discharge. History is significant for: Classical migraine headache associated with right jaw tingling; cardiac murmur with prior
evaluation; allergy to iodine dye (tachycardia); and habit of drinking 1.5 quart of caffeinated soda daily.
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