Vioxx (Rofecoxib) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

OSTEOARTHRITIS

Approximately 3600 patients with osteoarthritis were treated with VIOXX; approximately 1400 patients received VIOXX for 6 months or longer and approximately 800 patients for one year or longer. The following table of adverse experiences lists all adverse events, regardless of causality, occurring in at least 2% of patients receiving VIOXX in nine controlled studies of 6-week to 6-month duration conducted in patients with OA at the therapeutically recommended doses (12.5 and 25 mg), which included a placebo and/or positive control group.

In the OA studies, the following spontaneous adverse events occurred in >0.1% to 1.9% of patients treated with VIOXX regardless of causality:

Body as a Whole: abdominal distension, abdominal tenderness, abscess, chest pain, chills, contusion, cyst, diaphragmatic hernia, fever, fluid retention, flushing, fungal infection, infection, laceration, pain, pelvic pain, peripheral edema, postoperative pain, syncope, trauma, upper extremity edema, viral syndrome.

Cardiovascular System: angina pectoris, atrial fibrillation, bradycardia, hematoma, irregular heartbeat, palpitation, premature ventricular contraction, tachycardia, venous insufficiency.

Digestive System: acid reflux, aphthous stomatitis, constipation, dental caries, dental pain, digestive gas symptoms, dry mouth, duodenal disorder, dysgeusia, esophagitis, flatulence, gastric disorder, gastritis, gastroenteritis, hematochezia, hemorrhoids, infectious gastroenteritis, oral infection, oral lesion, oral ulcer, vomiting.

Eyes, Ears, Nose, and Throat: allergic rhinitis, blurred vision, cerumen impaction, conjunctivitis, dry throat, epistaxis, laryngitis, nasal congestion, nasal secretion, ophthalmic injection, otic pain, otitis, otitis media, pharyngitis, tinnitus, tonsillitis.

Immune System: allergy, hypersensitivity, insect bite reaction.

Metabolism and Nutrition: appetite change, hypercholesterolemia, weight gain.

Musculoskeletal System: ankle sprain, arm pain, arthralgia, back strain, bursitis, cartilage trauma, joint swelling, muscular cramp, muscular disorder, muscular weakness, musculoskeletal pain, musculoskeletal stiffness, myalgia, osteoarthritis, tendinitis, traumatic arthropathy, wrist fracture.

Nervous System: hypesthesia, insomnia, median nerve neuropathy, migraine, muscular spasm, paresthesia, sciatica, somnolence, vertigo.

Psychiatric: anxiety, depression, mental acuity decreased.

Respiratory System: asthma, cough, dyspnea, pneumonia, pulmonary congestion, respiratory infection.

Skin and Skin Appendages: abrasion, alopecia, atopic dermatitis, basal cell carcinoma, blister, cellulitis, contact dermatitis, herpes simplex, herpes zoster, nail unit disorder, perspiration, pruritus, rash, skin erythema, urticaria, xerosis.

Urogenital System: breast mass, cystitis, dysuria, menopausal symptoms, menstrual disorder, nocturia, urinary retention, vaginitis.

The following serious adverse events have been reported rarely (estimated <0.1%) in patients taking VIOXX, regardless of causality. Cases reported only in the post-marketing experience are indicated in italics.

Cardiovascular: cerebrovascular accident, congestive heart failure, deep venous thrombosis, hypertensive crisis, myocardial infarction, pulmonary edema, pulmonary embolism, transient ischemic attack, unstable angina.

Gastrointestinal: cholecystitis, colitis, colonic malignant neoplasm, duodenal perforation, duodenal ulcer, esophageal ulcer, gastric perforation, gastric ulcer, gastrointestinal bleeding, hepatic failure, hepatitis, intestinal obstruction, jaundice, pancreatitis.

Hemic and lymphatic: agranulocytosis, aplastic anemia, leukopenia, lymphoma, pancytopenia, thrombocytopenia.

Immune System: anaphylactic/anaphylactoid reaction, angioedema, bronchospasm, hypersensitivity vasculitis.

Metabolism and nutrition: hyponatremia.

Nervous System: aseptic meningitis, epilepsy aggravated.

Psychiatric: confusion, hallucinations.

Skin and Skin Appendages: photosensitivity reactions, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Urogenital System: acute renal failure, breast malignant neoplasm, hyperkalemia, interstitial nephritis, prostatic malignant neoplasm, urolithiasis, worsening chronic renal failure.

In 1-year controlled clinical trials and in extension studies for up to 86 weeks (approximately 800 patients treated with VIOXX for one year or longer), the adverse experience profile was qualitatively similar to that observed in studies of shorter duration.

RHEUMATOID ARTHRITIS

Approximately 1,100 patients were treated with VIOXX in the Phase III rheumatoid arthritis efficacy studies. These studies included extensions of up to 1 year. The adverse experience profile was generally similar to that reported in the osteoarthritis studies. In studies of at least three months, the incidence of hypertension in RA patients receiving the 25 mg once daily dose of VIOXX was 10.0% and the incidence of hypertension in patients receiving naproxen 500 mg twice daily was 4.7%.

ANALGESIA, INCLUDING PRIMARY DYSMENORRHEA

Approximately one thousand patients were treated with VIOXX in analgesia studies. All patients in post-dental surgery pain studies received only a single dose of study medication. Patients in primary dysmenorrhea studies may have taken up to 3 daily doses of VIOXX, and those in the post-orthopedic surgery pain study were prescribed 5 daily doses of VIOXX.

The adverse experience profile in the analgesia studies was generally similar to those reported in the osteoarthritis studies. The following additional adverse experience, which occurred at an incidence of at least 2% of patients treated with VIOXX, was observed in the post-dental pain surgery studies: post-dental extraction alveolitis (dry socket).

MIGRAINE WITH OR WITHOUT AURA

Approximately 750 patients were treated with a single dose of VIOXX 25 mg or 50 mg in two single-attack migraine studies. Approximately 460 patients in the 3-month extension phase of one study treated up to 8 (average 3) migraine attacks per month. In single attack studies, the following adverse events were more frequent in the VIOXX treatment groups (25 mg and 50 mg) compared to the placebo group, and occurred at an incidence of at least 2% of patients treated: dizziness, nausea, somnolence and dyspepsia. In the 3-month extension phase of one study, the following adverse events occurred at an incidence of at least 2% of patients treated in the VIOXX treatment groups (25 mg and 50 mg): dizziness, dry mouth, nausea, and vomiting.

CLINICAL STUDIES IN OA AND RA WITH VIOXX 50 MG (TWICE THE HIGHEST DOSE RECOMMENDED FOR CHRONIC USE)

In OA and RA clinical trials which contained VIOXX 12.5 or 25 mg as well as VIOXX 50 mg, VIOXX 50 mg QD was associated with a higher incidence of gastrointestinal symptoms (abdominal pain, epigastric pain, heartburn, nausea and vomiting), lower extremity edema, hypertension, serious * adverse experiences and discontinuation due to clinical adverse experiences compared to the recommended chronic doses of 12.5 and 25 mg (see DOSAGE AND ADMINISTRATION).

---

*adverse experience that resulted in death, permanent or substantial disability, hospitalization, congenital anomaly, or cancer, was immediately life threatening, was due to an overdose, or was thought by the investigator to require intervention to prevent one of the above outcomes

REPORTS OF SUSPECTED VIOXX SIDE EFFECTS / ADVERSE REACTIONS

Possible Vioxx side effects / adverse reactions in 46 year old male

Reported by a physician from United States on 2011-10-04

Patient: 46 year old male weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Back Pain, Osteopenia, Lumbar Vertebral Fracture, Dysphonia, Compression Fracture, Gastrointestinal Disorder, Anosmia, Pseudarthrosis, Adverse Drug Reaction, Change of Bowel Habit, Fall, Muscle Strain, Urosepsis, Depression, Bone Disorder, Renal Failure Acute, Emphysema, Dyspnoea, Vomiting, Impaired Healing, Sepsis, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Thirst, Headache, Pyrexia, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Device Malfunction, Ankylosing Spondylitis, Anaemia, Hyperglycaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Nephropathy, Wrist Fracture, Pain, Fatigue, Road Traffic Accident, Neck Pain, Sinusitis, Wound Drainage, Nausea, Rash, Steroid Therapy, Diarrhoea, Lipase Increased, Spinal Disorder, Arthritis, Hypertension, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2001-01-01

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Other drugs received by patient: Oxycontin; Protonix; Prednisone; Clonopin

Possible Vioxx side effects / adverse reactions in 46 year old male

Reported by a physician from United States on 2011-10-04

Patient: 46 year old male weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Lumbar Vertebral Fracture, Osteopenia, Dysphonia, Compression Fracture, Gastrointestinal Disorder, Polyarthritis, Anosmia, Pseudarthrosis, Adverse Drug Reaction, Fall, Change of Bowel Habit, Muscle Strain, Urosepsis, Bone Disorder, Depression, Renal Failure Acute, Emphysema, Dyspnoea, Vomiting, Impaired Healing, Sepsis, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Headache, Pyrexia, Thirst, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Joint Effusion, Device Malfunction, Ankylosing Spondylitis, Hyperglycaemia, Anaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Nephropathy, Wrist Fracture, Pain, Fatigue, Road Traffic Accident, Neck Pain, Wound Drainage, Sinusitis, Nausea, Synovitis, Rash, Steroid Therapy, Diarrhoea, Lipase Increased, Spinal Disorder, Hypertension, Arthritis, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2002-03-28

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Other drugs received by patient: Prednisone; Oxycontin; Protonix; Clonopin

Possible Vioxx side effects / adverse reactions in 84 year old female

Reported by a consumer/non-health professional from United States on 2011-10-12

Patient: 84 year old female

Reactions: Drug Dose Omission, Thrombosis, Anaemia, Typhoid Fever, Pulmonary Embolism, Abnormal Behaviour, Blood Glucose Fluctuation

Adverse event resulted in: hospitalization

Suspect drug(s):
Aricept
    Indication: Product Used FOR Unknown Indication

Fish OIL (Fish Oil)
    Indication: Product Used FOR Unknown Indication

Calcium Carbonate
    Indication: Product Used FOR Unknown Indication

Glyburide
    Indication: Product Used FOR Unknown Indication

Vioxx
    Indication: Product Used FOR Unknown Indication

Fosamax
    Indication: Product Used FOR Unknown Indication