|
Multiple Sclerosis
Depression, suicidal
ideation, and suicide attempts have been reported to occur with
increased frequency in patients receiving interferon compounds
to treat multiple sclerosis, inc. Betaseron
|
|
|
|
|
|
Multiple
Sclerosis (MS) Drugs
|
|
|
Betaseron
® Side Effects
|
(interferon beta-1b)
|
| |
Adverse Events Significantly Associated
With Betaseron
®
(Betaferon
®)
|
| |
| The following listings are events which have been reported in pre-marketing
clinical trials of Betaseron ®. Events are listed within
body system categories.
Unless otherwise stated, it is unknown whether
the events are related to exposure to Betaseron ®.
Adverse event reporting falls
into two types:
Significantly associated
with the use of Betaseron; and Infrequently reported events.
To be defined as significantly
associated with Betaseron, an adverse event had to fulfill two criteria:
at least 2% of patients
exposed to Betaseron ® and 2% greater
than placebo control.
|
| |
Adverse Events Significantly Associated with Betaseron (Betaferon)
|
|
|
|
Body as a whole |
|
Injection site
reaction (85%), fever (59%), flu-like complex (76%), asthenia
(49%), malaise (15%), injection site necrosis (5%).
|
| |
|
Cardiovascular |
|
Palpitation (8%)
|
| |
|
Haemic and Lymphatic |
|
ANC (antinuclear
antibody) < 1500/mm3 (18%)
WBC (white
blood cell count) < 3000/mm3 (16%)
|
| |
|
Metabolic and Nutritional |
|
SGPT (serum
glutamic-pyruvic transaminase) > 5 times baseline (19%)
SGOT (serum
glutamic oxaloacetic transaminase) > 5 times baseline (4%)
|
| |
|
Musculoskeletal |
|
Mylagia (44%)
|
| |
|
Respiratory |
|
Dyspnea (8%)
|
| |
|
Skin and appendages |
|
Sweating (23%)
|
| |
|
Urogenital |
|
Abnormal menstruation
and Menstrual disorder (17%)
|
| |
|
| |
| % figures in brackets represent the
percentage of the control group of 124 (N=124) reporting the event |
| |
| |
Infrequent Adverse Events reported during pre-marketing
clinic trials
|
| |
|
Infrequently reported
events:
pre-marketing evaluation
of various doses of Betaseron ® in 1440 patients. Exact figures
are unavailable. It cannot be reliably determined the role or otherwise
of Betaseron ® in these events.
|
| |
|
Infrequent Adverse Events Reported
|
| |
|
Body as a whole |
|
Abscess, adenoma, anaphylactoid reaction, ascites, cellulitis,
hernia, hydrocephalus, hypothermia, infection, peritonitis, photosensitivity,
sarcoma, sepsis, shock. |
| |
|
Cardiovascular |
|
Angina pectoris, arrhythmia, atrial fibrillation, cardiomegaly,
cardiac arrest, cerebral haemorrhage, cerebral ischemia, endocarditis,
heart failure, hypotension, myocardial infarct, pericardial effusion,
postural hypotension, pulmonary embolus, spider angioma, subarachnoid
haemorrhage, syncope, thrombophlebitis, thrombosis, varicose vein,
vasospasm, venous pressure increased, ventricular extrasystoles,
ventricular fibrillation. |
| |
|
Digestive |
|
Aphthous stomatitis, cardiospasm, cheilitis, cholecystitis, cholelithiasis,
duodenal ulcer, dry mouth, enteritis, esophagitis, fecal impaction,
fecal incontinence, flatulence, gastritis, gastrointestinal hemorrhage,
gingivitis, glossitis, hematemesis, hepatic neoplasia, hepatitis,
hepatomegaly, ileus, increased salivation, intestinal obstruction,
melena, nausea, oral leukoplakia, oral moniliasis, pancreatitis,
periodontal abscess, proctitis, rectal hemorrhage, salivary gland
enlargement, stomach ulcer, tenesmus. |
| |
|
Endocrine |
|
Cushing’s Syndrome, diabetes insipidus, diabetes mellitus, hypothyroidism,
inappropriate ADH (antidiuretic hormone). |
| |
|
Haemic and Lymphatic |
|
Chronic lymphocytic leukemia, haemoglobin less than 9.4 g/100
mL, petechia, platelets less than 75,000/mm3, splenomegaly. |
| |
|
Metabolic and Nutritional |
|
Alcohol intolerance, alkaline phosphatase greater than 5 times
baseline value, BUN (blood urea nitrogen) greater than 40 mg/dL,
calcium greater than 11.5 mg/dL, cyanosis, edema, glucose greater
than 160 mg/dL, glycosuria, hypoglycemic reaction, hypoxia, ketosis,
thirst. |
| |
|
Musculoskeletal |
|
Arthritis, arthrosis, bursitis, leg cramps, muscle atrophy, myopathy,
myositis, ptosis, tenosynovitis. |
| |
|
Nervous |
|
Abnormal gait, acute brain syndrome, agitation, apathy, aphasia,
ataxia, brain edema, chronic brain syndrome, coma, delirium, delusions,
dementia, depersonalization, diplopia, dystonia, encephalopathy,
euphoria, facial paralysis, foot drop, hallucinations, hemiplegia,
hypalgesia, hyperesthesia, incoordination, intracranial hypertension,
libido decreased, manic reaction, meningitis, neuralgia, neuropathy,
neurosis, nystagmus, oculogyric crisis, ophthalmoplegia, papilledema,
paralysis, paranoid reaction, psychosis, reflexes decreased, stupor,
subdural hematoma, torticollis, tremor, urinary retention. |
| |
|
Respiratory |
|
Apnea, asthma, atelectasis, carcinoma of lung, hemoptysis, hiccup,
hyperventilation, hypoventilation, interstitial pneumonia, lung
edema, pleural effusion, pneumonia, pneumothorax. |
| |
|
Skin and appendages |
|
Contact dermatitis, erythema nodosum, exfoliative dermatitis,
furunculosis, hirsutism, leukoderma, lichenoid dermatitis, maculopapular
rash, psoriasis, seborrhea, skin benign neoplasm, skin carcinoma,
skin hypertrophy, skin necrosis, skin ulcer, urticaria, vesiculobullous
rash. |
| |
|
Special senses |
|
Blepharitis, blindness, deafness, dry eyes, ear pain, iritis,
keratoconjunctivitis, mydriasis, otitis externa, otitis media,
parosmia, photophobia, retinitis, taste loss, taste perversion,
visual field defect. |
| |
|
Urogenital |
|
Anuria, balanitis, breast engorgement, cervicitis, epididymitis,
gynecomastia, hematuria, impotence, kidney calculus, kidney failure,
kidney tubular disorder, leukorrhea, nephritis, nocturia, oliguria,
polyuria, salpingitis, urethritis, urinary incontinence, uterine
fibroids enlarged, uterine neoplasm, vaginal hemorrhage. |
| |
|
| |
|
|
| Reviewed July 2004 |
|
|
|
