Ten years of adverse drug reaction reports for the multiple sclerosis immunomodulatory therapies: A Canadian perspective

Multiple Sclerosis

Volumn 14, Issue 1, 2008, Pages 94-105

  Tremlett, Helen L ^a   Oger, J ^a  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

Adverse drug reactions; Beta interferon; Glatiramer acetate; Immunomodulatory drugs; Multiple sclerosis; Pharmacovigilance; Post marketing surveillance

Indexed keywords

ALLOPURINOL; AMANTADINE; AMITRIPTYLINE; ATORVASTATIN; BACLOFEN; BETA INTERFERON; BETA1A INTERFERON; CLOPIDOGREL; DIAZEPAM; ENOXAPARIN; GABAPENTIN; GLATIRAMER; GLYCEROL; IBUPROFEN; IMMUNOMODULATING AGENT; INTERFERON BETA SERINE; LEVOTHYROXINE; LITHIUM; LORAZEPAM; METOPROLOL; MODAFINIL; NADOLOL; NIFEDIPINE; PARACETAMOL; PREDNISONE; RAMIPRIL; ROBAXACET; ROFECOXIB; SERTRALINE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VERAPAMIL; IMMUNOLOGIC FACTOR; IMMUNOLOGICAL ADJUVANT; PEPTIDE;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ABORTION; ACNE; ACUTE KIDNEY FAILURE; ACUTE LEUKEMIA; ADOLESCENT; ADULT; AGED; AKINESIA; ANOREXIA; ANXIETY; AORTA RUPTURE; APPETITE; ARTERIOSCLEROSIS; ARTICLE; ASPIRATION PNEUMONIA; BACKACHE; BALANCE DISORDER; BIPOLAR DISORDER; BLEEDING; BLOOD CLOTTING DISORDER; BLOOD TOXICITY; BONE MARROW TOXICITY; BONE METASTASIS; BRAIN EDEMA; BRAIN HEMORRHAGE; BRAIN METASTASIS; BRAIN TUMOR; BRONCHOPNEUMONIA; CANADA; CARDIOMEGALY; CEREBROVASCULAR ACCIDENT; CHEST TIGHTNESS; CHROMOSOME DISORDER; COLIC; COLON CARCINOMA; COMA; CONFUSION; CONGENITAL MALFORMATION; CONGESTIVE HEART FAILURE; CONSUMER; CONVULSION; COUGHING; CRYING; DEEP VEIN THROMBOSIS; DEHYDRATION; DELUSION; DEPRESSION; DEVELOPMENTAL DISORDER; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; DYSPNEA; EAR DISEASE; EDEMA; ENCEPHALITIS; ENDOCRINE DISEASE; ENTEROPATHY; EPILEPTIC STATE; ERYTHEMA; EYE DISEASE; FACE EDEMA; FACIAL NERVE PARALYSIS; FALLING; FATIGUE; FEEDING DISORDER; FEMALE; GASTROINTESTINAL SYMPTOM; GASTROINTESTINAL TUMOR; GENITAL SYSTEM DISEASE; GROWTH DISORDER; HALLUCINATION; HEADACHE; HEALTH CARE DELIVERY; HEALTH CARE PERSONNEL; HEART ARREST; HEART ARRHYTHMIA; HEART DISEASE; HEART INFARCTION; HEMORRHOID; HEPATOBILIARY DISEASE; HIP DISLOCATION; HUMAN; HYPOACUSIS; HYPOTHERMIA; IMMUNOMODULATION; INDIGESTION; INFECTION; INGROWN NAIL; INJECTION SITE PAIN; INJECTION SITE REACTION; INTESTINAL DYSMOTILITY; INTESTINE ULCER; JAUNDICE; JOINT STIFFNESS; KIDNEY DYSFUNCTION; KIDNEY FAILURE; LEG EDEMA; LETHARGY; LIVER FAILURE; LIVER METASTASIS; LIVER TUMOR; LOW BIRTH WEIGHT; LOWER RESPIRATORY TRACT INFECTION; LUNG CARCINOMA; LUNG CONGESTION; LUNG DISEASE; LUNG EMBOLISM; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALAISE; MALE; MALIGNANT NEOPLASTIC DISEASE; MENINGITIS; METABOLIC DISORDER; MICTURITION DISORDER; MIGRAINE; MULTIPLE SCLEROSIS; MUSCLE STIFFNESS; MUSCULOSKELETAL DISEASE; MYELITIS; NAUSEA; NECK PAIN; NEONATAL RESPIRATORY DISTRESS SYNDROME; NEUROLOGIC DISEASE; NEUROLOGIC EXAMINATION; NEUTROPENIA; NURSE; OVARY CARCINOMA; PAIN; PANCREAS CANCER; PANCREAS CARCINOMA; PANCREAS DISEASE; PAPILLEDEMA; PARANOIA; PATHOLOGIC FRACTURE; PATIENT CARE; PERICARDIAL EFFUSION; PERIPHERAL VASCULAR DISEASE; PHARMACIST; PHYSICIAN; PLEURA EFFUSION; PNEUMONIA; PNEUMOTHORAX; PRURITUS; PUPIL DISEASE; RESPIRATORY FAILURE; RESPIRATORY TRACT DISEASE; RHABDOMYOLYSIS; SCHOOL CHILD; SCLERODERMA; SEPSIS; SEPTIC SHOCK; SEXUAL DYSFUNCTION; SHOULDER PAIN; SIDE EFFECT; SKIN ALLERGY; SKIN MANIFESTATION; SKIN NECROSIS; SKIN ULCER; SLURRED SPEECH; SOFT TISSUE DEFECT; SOMNOLENCE; SPINE MALFORMATION; SPONTANEOUS ABORTION; STAPHYLOCOCCUS INFECTION; SUICIDAL IDEATION; SUICIDE; THORAX PAIN; TUMOR THROMBUS; UNCONSCIOUSNESS; URINARY TRACT INFECTION; UROGENITAL TRACT DISEASE; VASCULAR DISEASE; VIRUS INFECTION; VISUAL DISORDER; VOMITING; WEAKNESS; WEIGHT REDUCTION; CHILD; MIDDLE AGED; PREGNANCY; PREGNANCY COMPLICATION; STATISTICS;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; CANADA; CHILD; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; INTERFERON-BETA; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; PEPTIDES; PREGNANCY; PREGNANCY COMPLICATIONS;

EID: 42149129419     PISSN: 13524585     EISSN: None     Source Type: Journal    
DOI: 10.1177/1352458507079658     Document Type: Article

References (37)

1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 200-205.
2. Pirmohamed M, James S, Meakin S et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. Br Med J 2004; 329: 15-19.
3. Stephens MDB, Talbot JCC, Waller P. Stephens' detection of new adverse drug reactions, 5th edition. Wiley, 2004.
4. Lewis JA. Post-marketing surveillance - how many patients? Trends in Pharmacological Sciences 1981; 2: 93-94.
5. United States Government Accountability Office. GAO/PEMD-90-15 FDA Drug Review. Post-approval Risks 1976-85. http://archive.gao.gov/d24t8/ 141456.pdf (accessed 19 October 2006).
6. Strom BL. How the US drug safety system should be changed. JAMA 2006; 295: 2072-75.
7. United States Government Accountability Office. GAO-06-402: Drug Safety. Improvement Needed in FDA's Post-market Decision-making and Oversight Process. http://www.gao.gov/new.items/d06402.pdf (accessed 19 October 2006).
8. Pascale Olivier J-LM. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf 2006; 15: 808-12.
9. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med 2005; 165: 1363-69.
10. Hartmann K, Doser AK, Kuhn M. Postmarketing safety information: how useful are spontaneous reports? Pharmacoepidemiol Drug Saf 1999; 8(Suppl 1): S65-71.
11. van Puijenbroek EP, Egberts AC, Heerdink ER, Leufkens HG. Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: an example with diuretics and non-steroidal anti-inflammatory drugs. Eur J Clin Pharmacol 2000; 56: 733-38.
12. Rawlins MD. Spontaneous reporting of adverse drug reactions I: the data. Br J Clin Pharmacol 1988; 26: 1-5.
13. Health Canada. Med Effect. Adverse Drug Reporting http://www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html (accessed 19 October 2006).
14. The Multiple Sclerosis International Federation. http://www.atlasofms.org/ An Atlas of MS. (accessed 17 August 2006).
15. Health Canada's Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Database. http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/ index_e.html (accessed 17 August 2006).
16. Anonymous. Common Terminology Criteria for Adverse Events. http://ctep.cancer.gov/reporting/ctc.html (accessed October 2006).
17. Boskovic R, Wide R, Wolpin J, Dauer DJ, Koren G. The reproductive effects of beta interferon therapy in pregnancy: A longitudinal cohort. Neurology 2005; 65: 807-11.
18. Copaxone® monograph. In Repchinsky C ed. Compendium of pharmaceuticals and specialties. Canadian Pharmacists Association, Webcom Ltd, 2006.
19. Betaseron® monograph. In Repchinsky C ed. Compendium of pharmaceuticals and specialties (CPS). Canadian Pharmacists Association, Webcom Ltd, 2006.
20. Rebif® monograph. In Repchinsky C ed. Compendium or pharmaceuticals and specialties. Canadian Pharmacists Association, 2006.
21. Avonex® monograph. In Repchinsky C ed. Compendium of pharmaceuticals and specialties. Canadian Pharmacists Association, Webcom Ltd, 2006.
22. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993; 43: 655-61.
23. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/ remitting multiple sclerosis. Lancet 1998; 352: 1498-504.
24. Jacobs LD, Cookfair DL, Rudick RA et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol 1996; 39: 285-94.
25. Johnson K.P, Brooks BR, Cohen JA et al. Copolymer I reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicentre, double-blind placebo-controlled trial. Neurology 1995; 45: 1268-76.
26. Pohl D, Rostasy K, Gartner J, Hanefeld F. Treatment of early onset multiple sclerosis with subcutaneous interferon beta-1a. Neurology 2005; 64: 888-90.
27. Banwell B, Reder AT, Krupp L et al. Safety and tolerability of interferon beta-1b in pediatric multiple sclerosis. Neurology 2006; 66: 472-76.
28. Thurmann PA. Methods and systems to detect adverse drug reactions in hospitals. Drug Saf 2001; 24: 961-68.
29. Public Health Agency of Canada (PHAC), Health Statistics. (http://dsol-smed.hc-sc.gc.ca/dsol-smed/cancer/d_dis_e.html; accessed October 06).
30. Achiron A, Barak Y, Gail M et al. Cancer incidence in multiple sclerosis and effects of immunomodulatory treatments. Breast Cancer Res Treat 2005; 89: 265-70.
31. Baxter K, Stockley IH. Stockley's drug interactions: a source book of interactions, their mechanisms, clinical importance and management, 7th edition. Pharmaceutical Press, 2006.
32. Martindale. The complete drug reference. Pharmaceutical Press, 2005.
33. Gehshan A, Ruebig A, Salesse M. Important new safety information: Hepatic injury associated with beta-interferon treatment for multiple sclerosis (http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ beta-interferon_hpc_e.pdf; accessed December 2003).
34. Kappos L, Traboulsee A, Constantinescu C et al. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology 2006; 67: 944-53.
35. Ford CC, Johnson KP, Lisak RP, Panitch US, Shifronis G, Wolinsky JS. A prospective open-label study of glatiramer acetate: over a decade of continuous use in multiple sclerosis patients. Mult Scler 2006; 12: 309-20.
36. Ebers G, Traboulsee A, Li D et al. Final results from the interferon beta-1b 16-year long-term follow-up study (abstract, P666) Mult Scler 2006; 12(Suppl 1): S189.
37. Sega S, Horvat A, Popovic M. Anaplastic oligodendroglioma and gliomatosis type 2 in interferon-beta treated multiple sclerosis patients. Report of two cases. Clin Neurol Neurosurg 2006; 108: 259-65.