Clinical Safety Experience with PREVACID I.V. (lansoprazole for injection) for Injection
More than 1,000 patients and subjects have participated in domestic and foreign clinical trials. Treatment with PREVACID I.V. (lansoprazole for injection) for Injection was well-tolerated.
In four U.S. trials involving 161 subjects exposed to PREVACID I.V. (lansoprazole for injection) for Injection, the following treatment-related adverse events were reported in ≥ 1% of subjects: headache (1.0%), injection site pain (1.0%), injection site reaction (1.0%) and nausea (1.3%). Treatment-related adverse events occurring in less than 1% of subjects included abdominal pain, vasodilatation, diarrhea, dyspepsia, vomiting, dizziness, paresthesia, rash, and taste perversion. No additional adverse drug reactions were reported with the intravenous formulation that had not been reported previously with the oral formulations.
Clinical Safety Experience with Oral Formulations of PREVACID
Worldwide, over 10,000 patients have been treated with oral PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials.
The following adverse events were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of PREVACID-treated patients and occurred at a greater rate in PREVACID-treated patients than placebo-treated patients in Table 4.
Table 4: Incidence of Possibly or Probably Treatment-Related
Adverse Events in
Short-Term, Placebo-Controlled PREVACID Studies
| Body System/Adverse Event
| Body as a Whole
| Abdominal Pain
| Digestive System
Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9%, 1.4%, 4.2%, and 7.4%, respectively).
Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:
Body as a Whole - abdomen enlarged, allergic reaction,
asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified),
chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified),
malaise, neck pain, neck rigidity, pain, pelvic pain; Cardiovascular System
- angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction,
hypertension/ hypotension, migraine, myocardial infarction, palpitations, shock
(circulatory failure), syncope, tachycardia, vasodilation; Digestive System
- abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry
mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal
ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic
gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal
disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis,
increased appetite, increased salivation, melena, mouth ulceration, nausea and
vomiting, nausea and vomiting and diarrhea, oral moniliasis, rectal disorder,
rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative
colitis, ulcerative stomatitis; Endocrine System - diabetes mellitus,
goiter, hypothyroidism; Hemic and Lymphatic System - anemia,
hemolysis, lymphadenopathy; Metabolic and Nutritional Disorders
- gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss;
Musculoskeletal System - arthralgia, arthritis, bone disorder,
joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, synovitis;
Nervous System - abnormal dreams, agitation, amnesia, anxiety,
apathy, confusion, convulsion, depersonalization, depression, diplopia, dizziness,
emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia,
hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness,
neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor,
vertigo; Respiratory System - asthma, bronchitis, cough increased,
dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, pharyngitis, pleural
disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection,
rhinitis, sinusitis, stridor; Skin and Appendages -acne,
alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular
rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating,
urticaria; Special Senses -abnormal vision, blurred vision,
conjunctivitis, deafness, dry eyes, ear disorder, eye pain, otitis media, parosmia,
photophobia, retinal degeneration, taste loss, taste perversion, tinnitus, visual
field defect; Urogenital System - abnormal menses, breast enlargement,
breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence,
kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis
disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary
tract infection, urinary urgency, urination impaired, vaginitis.
Additional adverse experiences have been reported since oral PREVACID has been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID has not been established. Because these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.
Body as a Whole -anaphylactic/anaphylactoid reactions; Digestive
System - hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic
System - agranulocytosis, aplastic anemia, hemolytic anemia,
leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic
purpura; Musculoskeletal System - myositis; Skin
and Appendages - severe dermatologic reactions including erythema
multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal);
Special Senses - speech disorder; Urogenital System
- interstitial nephritis, urinary retention.
There were no clinically important changes identified in any laboratory parameter with PREVACID I.V. (lansoprazole for injection) for Injection.
The following changes in laboratory parameters in patients who received PREVACID were reported as adverse events:
Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, eosinophilia, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, and increased gastrin levels. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.
In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and PREVACID, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received PREVACID reported jaundice at any time during the study.