Caffeine is able to penetrate the blood brain barrier and directly influence the CNS Roche Issues Notice Regarding Lariam

POST MARKETING REPORTS: FDA MED WATCH PROGRAM

From the FDA's Med Watch Database; Nov. 1, 1997 to June 6, 2005:

Levaquin - Nov. 1, 1997 to June 6, 2005
Total individual safety reports: 7,118
Total reactions: 28,061
Total death outcomes by case: 628

Cipro - Nov. 1, 1997 - June 6, 2005
Total individual safety reports: 6,292
Total reactions: 27,893
Total death outcomes by case: 624

Trovan - Nov. 1, 1997 - May 25, 2005
Total individual safety reports: 5,087
Total reactions: 24,328
Total death outcomes by case: 239

Floxin - Nov. 1, 1997 to May 25, 2005
Total individual safety reports: 2,478
Total reactions: 11,000
Total death outcomes by case: 249

Tequin - Nov. 1, 1997 to May 25, 2005
Total individual safety reports: 4,180
Total reactions: 12,181
Total death outcomes by case: 151

Avelox - Nov 1, 1997 to May 25, 2005
Total individual safety reports: 5,165
Total reactions: 19,454
Total death outcomes by case: 199

THE FOLLOWING TABLES ARE BASED ON THE MEDWATCH DATABASE AS REPORTED BY A FREEDOM OF INFORMATION REQUEST 1997 - 2001

Table 1
Fluoroquinolones removed from clinical practice or use restricted

1962 Nalidixic Acid
1973 Flumequine
1985 Sparfloxacin
1988 Temafloxacin
1989 Grepafloxacin
1993 Trovafloxacin

Table 2
Severe adverse drug reactions associated with fluoroquinolone currently in use

1982 Ofloxacin [Severe peripheral neuropathy, spontaneous tendon rupture, CNS and PNS events, vision damage]
1983 Ciprofloxacin [Severe peripheral neuropathy, spontaneous tendon rupture, CNS and PNS events, vision damage]
1987 Levofloxacin [Severe peripheral neuropathy, spontaneous tendon rupture, CNS and PNS events, vision damage]
1994 Moxifloxacin [Severe peripheral neuropathy, spontaneous tendon rupture, CNS and PNS events, vision damage]

Table 3
Adverse Event Reporting System Summary 11-1-1997 to 10/2001
Bone, Tendon, Muscle and Ligament Damage Ciprofloxacin

Arthralgia 261 (within the top three reported events)
Pain in the Extremity 153
Myalgia 148
Tendinitis 122
Difficulty in walking 89
Tendon Rupture 89
Tendon Disorders 81
Rhabdomyolysis 66
Arthritis 42
Muscle Cramps 34
Arthropathy 34
Joint Swelling 32
Muscle Weakness 27
Neck Pain 19
Movement Disorders 19
Muscle Spasms 18
Limb Injury 18
Joint Stiffness 18
Muscle Twitching 17
Paralysis 16
Muscle Disorders 16
Osteoarthritis 15
Muscle Rupture 14
Musculoskeletal Stiffness 12
Polyarthritis 11
Tendon Injury 10
Tenosynovitis 9
Muscle Stiffness 8
Joint Effusion 8
Bone Pain 8
Rheumatoid Arthritis 7
Rotary Cuff Syndrome 6
Bone Disorders 6
Tongue Paralysis 5
Biopsy Bone Marrow Abnormal 5
Muscle Contractions Involuntary 4
Joint Sprain 4
Cartilage Injury 3
Musculoskeletal Discomfort 3
Muscle Necrosis 3
Joint Range of Motion Decreased 3
Joint Crepitation 3
Facial Bone Fracture 3
Connective Tissue Disorders 3
Buttock Pain 3
Cartilage Disorders 2
Ligament Disorders 2
Fibromyalgia 2
Musculoskeletal Disorders 2
Muscle Tightness 2
Muscle Strain 2
Muscle Spasticity 2
Muscle Rigidity 2
Muscle Injury 2
Muscle Fatigue 2
Mobility Decreased 2
Foot Fracture 1
Synovial Cyst 1
Skull Fractured Base 1
Rheumatoid Factor Positive 1
Posture Abnormal 1
Neuromuscular Disorders 1
Musculoskeletal Pain 1
Muscle Hemorrhage 1
Limb Discomforts 1
Joint Dislocation 1
Joint Arthropathy 1
Burning Sensation Mucosal 1
Finger Deformity 1
Bone Lesions 1
Bone Erosion 1
Arthritis Reactive 1
Arthritis Allergic 1
Ankle Fracture 1

TOTAL EVENTS REPORTED 1,558

Table 4
Adverse Event Reporting System Summary 11-1-1997 to 10/2001
Bone, Tendon, Muscle and Ligament Damage Levaquin

Arthralgia 368 (The number one event reported)
Tendon Disorders 318 (The number two event reported)
Tendonitis 232
Pain 204
Myalgia 193
Pain in the extremity 190
Asthenia 166
Difficulty walking 151
Paresthesia 127
Tendon Rupture 97
Rhabdomyolysis 66
Back pain 59
Swelling 50
Muscle Weakness 42
Joint Swelling 37
Muscle Twitching 30
Arthritis 30
Joint Stiffness 27
Muscle Cramp 25
Muscle Spasms 23
Movement Disorders 23
Myositis 20
Paralysis 18
Neck Pain 18
Muscle Rupture 16
Bone Pain 15
Contusions 15
Muscle Contractions Involuntary 14
Joint Effusion 12
Osteoarthritis 11
Muscle Injury 11
Muscle Atrophy 11
Cartilage Injury 11
Rotary Cuff Syndrome 10
Joint Ligament Rupture 10
Tendon Injury 9
Muscle Tightness 9
Muscle Stiffness 9
Musculoskeletal Stiffness 8
Muscle Disorders 8
Muscle Rigidity 6
Synovitis 6
Nuclear MRI Abnormal 5
Paresis 5
Joint Sprain 5
Joint Dislocation 5
Tenosynovitis 5
Cartilage Disorder 5
Carpal Tunnel Syndrome 5
Polyarthritis 4
Monoparesis 4
Fibromyalgia 4
Rheumatoid Factor Positive 3
Ligament Injury 3
Juvenile Arthritis 3
Jaw Disorders 3
Bone Disorders 3
Ligament Disorders 2
Joint Range of Motion Decreased 2
Fibromyalgia Syndrome 2
Polymyositis 2
Polymyalgia Rheumatica 2
Polymalgia 2
Osteopenia 2
Osteochondrosis 2
Orthopnoea 2
Muscle Hemorrhage 2
Arthritis Reactive 2
Atherosclerosis 2
Tendon Repair 1
Synovial cyst 1
Smooth Muscle Antibody Positive 1
Quadriplegia 1
Limb Discomfort 1
Joint Contracture 1
Humerus Fracture 1
Ganglion Cyst 1
Exercise Tolerance Decreased 1
Exercise Capacity Decreased 1
Musculoskeletal Pain 1
Musculoskeletal Disorders 1
Musculoskeletal Discomfort 1
Muscle Necrosis 1
Muscle Abscess 1
Menigus Lesion 1
Physical Disability 1
(Despite over hundreds of such reports filed by the
members of the adverse drug reaction forum)
Connective Tissue Disorders 1

TOTAL EVENTS REPORTED 2,898

Table 5
Adverse Event Reporting System Summary 11-1-1997 to 10/2001
Peripheral Neuropathy / Nuerotoxicity Ciprofloxacin

Pain 191
Paresthesia 99
Peripheral Neuropathy 58
Burning Sensations 43
Neurological Disorders 41
Polyneuropathy 30
Gamma-Glutamyltransferase Increased 29
Guillain Barre Syndrome 13
Neuralgia 12
Peripheral Sensory Neuropathy 7
Nerve Root Lesions 6
Neuropathy 5
Third Nerve Paralysis 4
Neurotoxicity 3
Neuropathic pain 3
Demyelization 2
Demyelinating Polyneuropathy 2
Skin burning sensation 2
Sjogren's Syndrome 2
Perineal Nerve Palsy 2
Peripheral Sensor Motor Neuropathy 2
Peripheral Coldness 2
Nerve Injury 2
Diabetic Neuropathy 1
Peripheral nerve injury 1
Peripheral Motor Neuropathy 1
Nerve Conduction Studies Abnormal 1
Nerve Compression 1
Neuromuscular Disorders 1
Burning sensation mucosal 1
TOTAL REPORTED EVENTS 567

Table 6
Adverse Event Reporting System Summary 11-1-1997 to 10/2001
Peripheral Neuropathy / Nuerotoxicity Nalidixic Acid

(Total number of reports contained within the summary 12, regardless of events)
Burning Sensation 1

TOTAL REPORTED EVENTS 1

Table 7
Adverse Event Reporting System Summary 11-1-1997 to 10/2001
Peripheral Neuropathy / Nuerotoxicity Levaquin

Burning sensations 55
Disseminated Intravascular Coagulation 43
Peripheral Neuropathy 34
Neurological Disorders 34
Polyneuropathy 23
Feeling hot 22
Epilepsy 9
Sensory Disturbances 9
Neuropathy 9
Feeling cold 9
Peripheral Ischemia 8
Nerve Injury 6
Peripheral coldness 6
Sensory loss 5
Peripheral nerve injury 4
Neurotoxicity 4
Central Nervous System Stimulation 4
Temperature intolerance 3
Myopathy toxic 3
Feeling hot and cold 3
Vith Nerve Paralysis 2
Perineal Nerve Injury 2
Peripheral Sensory Neuropathy 2
Demylelinating Polyneuropathy 2
Trigeminal Nerve Disorders 1
Sciatic Nerve Lesions 1
Diabetic Neuropathy 1
Nerve Root Injury Sacral 1
Nerve Conductive Studies Abnormal 1
Optic Nerve Injury 1
Neuropathic pain 1
Demyelization 1

TOTAL NUMBER OF REPORTS 309

ADVERSE DRUG REACTIONS ONLINE INFORMATION TRACKING in the United Kingdom

Ciprofloxacin: 5,643 ADRS / 70 Fatalities

Nalidixic Acid: 1,980 ADRS / 5 Fatalities

Ofloxacin: 1,580 ADRS / 10 Fatalities

Levaquin: 580 ADRS / 6 Fatalities

Norfloxacin: 438 ADRS / 2 Fatalities

Additional Research from Pubmed/Medline

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3 [No authors listed]Prulifloxacin. NAD-441A, NM 441, Quisnon.
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4 No authors listed]Gemifloxacin. Factive, LB 20304, SB 265805.
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13 [No authors listed]Sitafloxacin: DU 6859, DU 6859A, Gracevit, sitafloxacin hydrate.
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16 Tintinalli JE.Fluoroquinolones should be avoided in myasthenia gravis.
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6 Ahmad K.Drug company sued over research trial in Nigeria.
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8 Bergan T.Antibiotic usage in Nordic countries.
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27 Brown WM.Gatifloxacin Kyorin Pharmaceutical Co.
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28 Jiraskova N.Olamufloxacin. Hokuriku Seiyaku.
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53 Davey PG, Charter M, Kelly S, Varma TR, Jacobson I, Freeman A, Precious E, Lambert J.Ciprofloxacin and sparfloxacin penetration into human brain tissue and their activity as antagonists of GABAA receptor of rat vagus nerve.
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54 Dasgupta R, Mukhopadhyay S, Ganguly S.Adverse effects of quinolone antibiotics.
J Assoc Physicians India. 1994 Apr;42(4):348. No abstract available.
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55 Morita M, Hasuda A, Nakagawa H, Abe Y, Suzuki K.Accumulation of new quinolones in the blood of elderly patients.
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56 Oliaro A.[Rufloxacin: the first quinolone, the fruit of Italian research]
Minerva Pediatr. 1993 Apr;45(4):xv-xvi. Italian. No abstract available.
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57 Girdhar BK.Fluoroquinolones and their adverse effects.
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58 Suto MJ, Domagala JM, Roland GE, Mailloux GB, Cohen MA.Fluoroquinolones: relationships between structural variations, mammalian cell cytotoxicity, and antimicrobial activity.
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59 [No authors listed]Adverse effects prompt withdrawal of temafloxacin.
Clin Pharm. 1992 Sep;11(9):747, 750. No abstract available.
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60 Andrejak M, Schmit JL, Tondriaux A, Hary L, Debailleux S, Moore N.[Neurologic side effects of fluoroquinolones. Apropos of 9 cases concerning pefloxacin]
Therapie. 1992 Sep-Oct;47(5):415-8. French.
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61 Rapp RP.Temafloxacin voluntary withdrawal: concerns about multicenter testing and postmarketing surveillance.
Ann Pharmacother. 1992 Jul-Aug;26(7-8):995. No abstract available.
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62 Shimada J, Hori S.Adverse effects of fluoroquinolones.
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63 Patterson DR.Quinolone toxicity: methods of assessment.
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64 Krasula RW, Pernet AG.Comparison of organ-specific toxicity of temafloxacin in animals and humans.
Am J Med. 1991 Dec 30;91(6A):38S-41S.
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65 Krcmery V, Cepcek P.[Side effects and toxicity of new quinolones]
Bratisl Lek Listy. 1991 Oct;92(10):496-503. Review. Slovak.
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66 Unseld E, Ziegler G, Gemeinhardt A, Janssen U, Klotz U.Possible interaction of fluoroquinolones with the benzodiazepine-GABAA-receptor complex.
Br J Clin Pharmacol. 1990 Jul;30(1):63-70.
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67 Slama TG.Serum sickness-like illness associated with ciprofloxacin. (Previously unreported)
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