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Review Sibutramine Safety Reports submitted to FDA

Total Sibutramine reports: 31.
Sibutramine FDA safety alerts: 2007 .
Reported deaths: 4    Reported hospitalizations: 20.
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FDA Reported Sibutramine Side Effects: supraventricular tachycardia, psychotic disorder, depression, somnolence, paraesthesia, nuclear magnetic resonance imaging abnormal, headache, arthropathy, abortion spontaneous, intracranial pressure increased, pyromania.
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Sibutramine Side Effects Report #5647332-7
Physician from UNITED KINGDOM reported SIBUTRAMINE problem on Feb 25, 2008. Female patient, 29 years of age, weighting 176.4 lb, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, pancytopenia. SIBUTRAMINE dosage: unknown. Patient recovered.

Sibutramine Side Effects Report #5649620-7
SIBUTRAMINE problem was reported by a Consumer or non-health professional from BRAZIL on Feb 25, 2008. Female patient, 27 years of age, weighting 136.7 lb, was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: overdose, poisoning. SIBUTRAMINE dosage: unknown. During the same period patient was treated with DIETHYLPROPION. Patient died.

Sibutramine Side Effects Report #5655602-1
Consumer or non-health professional from SINGAPORE reported SIBUTRAMINE problem on Feb 28, 2008. Female patient was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: catatonia, psychotic disorder. SIBUTRAMINE dosage: unknown. Patient recovered.

Sibutramine Side Effects Report #5661191-8
SIBUTRAMINE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 03, 2008. Female patient, 26 years of age, weighting 88.18 lb, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: catatonia, psychotic disorder. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5668695-2
Consumer or non-health professional from BRAZIL reported SIBUTRAMINE problem on Mar 06, 2008. Female patient, 27 years of age, weighting 136.7 lb, was diagnosed with ex-smoker and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: overdose, poisoning. SIBUTRAMINE dosage: unknown. During the same period patient was treated with DIETHYLPROPION, BUPROPION. Patient died.

Sibutramine Side Effects Report #5689178-X
SIBUTRAMINE problem was reported by a Physician from BRAZIL on Mar 24, 2008. Female patient, 57 years of age, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: cerebral disorder, demyelination, dysphonia, muscle contracture, nervous system disorder, quadriplegia. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5611336-0
Physician from UNITED KINGDOM reported SIBUTRAMINE problem on Jan 24, 2008. Female patient, 34 years of age, weighting 202.8 lb, was diagnosed with obesity and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: gastroenteritis, haematemesis. SIBUTRAMINE dosage: unknown. During the same period patient was treated with NORGESTIMATE AND ETHINYL ESTRADIOL, TRIAMCINOLONE ACETONIDE, BECLOMETHASONE DIPROPIONATE, ALBUTEROL, CETIRIZINE. Patient recovered.

Sibutramine Side Effects Report #5600343-X
SIBUTRAMINE problem was reported by a Consumer or non-health professional from COLOMBIA on Jan 15, 2008. Male patient, 28 years of age, weighting 156.5 lb, was diagnosed with body dysmorphic disorder and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: affective disorder, blood pressure fluctuation, heart rate abnormal, psychotic behaviour. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5602847-2
Physician from UNITED KINGDOM reported SIBUTRAMINE problem on Jan 18, 2008. Male patient, 33 years of age, weighting 385.8 lb, was diagnosed with obesity, lower respiratory tract infection, wheezing and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, aortic dilatation, aortic rupture, cardiac arrest, cardiac tamponade, chest pain, connective tissue disorder, diffuse vasculitis, dyspnoea. SIBUTRAMINE dosage: unknown. During the same period patient was treated with AZITHROMYCIN, CEFACLOR, CLARITHROMYCIN, PREDNISOLONE. Patient was hospitalized. Patient died on 10/20/2006.

Sibutramine Side Effects Report #5610245-0
SIBUTRAMINE problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on Jan 23, 2008. Female patient, 32 years of age, was diagnosed with overweight, insomnia and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic coma, overdose. SIBUTRAMINE dosage: unknown. During the same period patient was treated with LORAZEPAM. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5533814-5
Consumer or non-health professional from SPAIN reported SIBUTRAMINE problem on Nov 27, 2007. Female patient, 46 years of age, was diagnosed with weight decreased and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: psychotic disorder. SIBUTRAMINE dosage: INCREASING S UP TO 14 MG/DAY. During the same period patient was treated with SIBUTRAMINE HYDROCHLORIDE CAPSULES. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5569599-6
SIBUTRAMINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Dec 10, 2007. Female patient, weighting 213.0 lb, was diagnosed with obesity, type 2 diabetes mellitus, analgesia, arthritis, hypertension, myocardial ischaemia, angina pectoris and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, iron deficiency anaemia, pulmonary fibrosis. SIBUTRAMINE dosage: unknown. During the same period patient was treated with METFORMIN, INSULIN, DIHYDROCODEINE, KETOPROFEN, FRUMIL, VALSARTAN, DOXAZOSIN MESYLATE, GLYCERYL TRINITRATE. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5504455-0
Consumer or non-health professional from BRAZIL reported SIBUTRAMINE problem on Oct 25, 2007. Female patient, 50 years of age, weighting 149.9 lb, was diagnosed with weight control, glaucoma and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: constipation, haemorrhoids, insomnia, vision blurred. SIBUTRAMINE dosage: unknown. During the same period patient was treated with THIOMUCASE, BRIMONIDINE TARTRATE. Patient recovered.

Sibutramine Side Effects Report #5503125-2
SIBUTRAMINE problem was reported by a Consumer or non-health professional from IRELAND on Oct 29, 2007. Female patient, weighting 134.5 lb, was diagnosed with obesity and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, amnesia, anger, back pain, crying, disturbance in attention, dry mouth, eye pain, feeling abnormal. SIBUTRAMINE dosage: 15MG TWICE DAILY PO. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5421158-1
Physician from UNITED KINGDOM reported SIBUTRAMINE problem on Aug 17, 2007. Male patient, 27 years of age, weighting 242.5 lb, was diagnosed with weight control, headache and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: intracranial pressure increased. SIBUTRAMINE dosage: unknown. During the same period patient was treated with ACETAMINOPHEN W, DICLOFENAC, MIGRALEVE. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5424592-9
SIBUTRAMINE problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on Aug 14, 2007. Female patient, weighting 187.4 lb, was diagnosed with obesity and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. SIBUTRAMINE dosage: unknown. Patient recovered.

Sibutramine Side Effects Report #5432126-8
Consumer or non-health professional from BRAZIL reported SIBUTRAMINE problem on Aug 20, 2007. Female patient, 62 years of age, weighting 172.0 lb, was diagnosed with weight control, arthralgia, hypertension and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: arthropathy. SIBUTRAMINE dosage: unknown. During the same period patient was treated with LUMIRACOXIB, INDERIDE. Patient recovered.

Sibutramine Side Effects Report #5380627-3
SIBUTRAMINE problem was reported by a Consumer or non-health professional from GERMANY on June 26, 2007. Female patient, 43 years of age, weighting 109.1 lb, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: aggression, apathy, attention deficit/hyperactivity disorder, depression, hallucination, visual, jealous delusion, persecutory delusion, psychotic disorder, pyromania. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5380627-3
Consumer or non-health professional from GERMANY reported SIBUTRAMINE problem on June 26, 2007. Female patient, 43 years of age, weighting 109.1 lb, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: aggression, apathy, attention deficit/hyperactivity disorder, depression, hallucination, visual, jealous delusion, persecutory delusion, psychotic disorder, pyromania. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5759945-2
SIBUTRAMINE problem was reported by a Physician from AUSTRALIA on May 28, 2008. Female patient, 23 years of age, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: psychiatric evaluation. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5736804-2
Consumer or non-health professional from POLAND reported SIBUTRAMINE problem on Apr 11, 2006. Male patient, weighting 231.5 lb, was diagnosed with obesity, coronary artery disease, hypertension and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest. SIBUTRAMINE dosage: unknown. During the same period patient was treated with METOPROLOL TARTRATE, METOPROLOL TARTRATE, AMILORIDE AND HYDROCHLOROTHIAZIDE, PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE, AMLODIPINE, ACETYLSALICYLIC ACID SRT. Patient died on 12/15/2003.

Sibutramine Side Effects Report #5751016-4
SIBUTRAMINE problem was reported by a Health Professional from UNITED KINGDOM on May 21, 2008. Male patient, weighting 374.8 lb, was diagnosed with obesity, diabetes mellitus, blood pressure increased and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia. SIBUTRAMINE dosage: unknown. During the same period patient was treated with ASPIRIN, BISOPROLOL, FUROSEMIDE, INSULIN GLARGINE, LISINOPRIL, METFORMIN, SIMVASTATIN. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5695290-1
Physician from BRAZIL reported SIBUTRAMINE problem on Mar 26, 2008. Female patient, 57 years of age, was diagnosed with weight decreased, obesity, hypothyroidism, hysterectomy and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: anorexia, demyelination, depression, dysphonia, dyspnoea, fatigue, gait disturbance, haematemesis, herpes simplex. SIBUTRAMINE dosage: unknown. During the same period patient was treated with AMFEPRAMONE HYDROCHLORIDE, LEVOTHYROXINE, BUMETANIDE, ESTRADIOL. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5699537-7
SIBUTRAMINE problem was reported by a Physician from UNITED KINGDOM on Apr 02, 2008. Female patient, 22 years of age, weighting 164.2 lb, was diagnosed with obesity, contraception and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: vaginal haemorrhage. SIBUTRAMINE dosage: unknown. During the same period patient was treated with EUGYNON. Patient recovered.

Sibutramine Side Effects Report #5357513-8
Physician from BELGIUM reported SIBUTRAMINE problem on June 05, 2007. Female patient, 76 years of age, was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: glaucoma. SIBUTRAMINE dosage: unknown. Patient recovered.

Sibutramine Side Effects Report #5375046-X
SIBUTRAMINE problem was reported by a Consumer or non-health professional from GERMANY on June 26, 2007. Male patient, 48 years of age, weighting 194.0 lb, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: agitation, anxiety, depressed mood, hallucination, auditory, psychotic disorder. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5321859-X
Physician from UNITED KINGDOM reported SIBUTRAMINE problem on May 02, 2007. Female patient, 25 years of age, weighting 257.9 lb, was diagnosed with weight control, contraception and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: depression, emotional disorder. SIBUTRAMINE dosage: unknown. During the same period patient was treated with DESOGESTREL. Patient recovered.

Sibutramine Side Effects Report #5333639-X
SIBUTRAMINE problem was reported by a Physician from UNITED KINGDOM on May 18, 2007. Female patient, 41 years of age, weighting 198.4 lb, was diagnosed with weight control and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: proctitis. SIBUTRAMINE dosage: unknown. During the same period patient was treated with LEVOTHYROXINE. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5283840-9
Consumer or non-health professional from SPAIN reported SIBUTRAMINE problem on Mar 23, 2007. Male patient, 50 years of age, was diagnosed with weight control, obesity and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: delusion. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5295026-2
SIBUTRAMINE problem was reported by a Consumer or non-health professional from FRANCE on Apr 04, 2007. Female patient, 47 years of age, weighting 198.4 lb, was diagnosed with overweight and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: headache, nuclear magnetic resonance imaging abnormal, paraesthesia, somnolence. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.

Sibutramine Side Effects Report #5308744-4
Consumer or non-health professional from FRANCE reported SIBUTRAMINE problem on Apr 17, 2007. Female patient, 47 years of age, weighting 198.4 lb, was diagnosed with overweight and was treated with SIBUTRAMINE. After drug was administered, patient experienced the following problems/side effects: headache, nuclear magnetic resonance imaging abnormal, paraesthesia, somnolence. SIBUTRAMINE dosage: unknown. Patient was hospitalized. Patient recovered.


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