ADVERSE REACTIONS
Clinical Trials Experience
The safety of DEXILANT was evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on DEXILANT 30 mg, 2218 patients on DEXILANT 60 mg, and 1363 patients on lansoprazole 30 mg once daily.
As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Most Commonly Reported Adverse Reactions
The most common adverse reactions (≥2%) that occurred at a higher incidence for DEXILANT than placebo in the controlled studies are presented in Table 2.
Table 2: Incidence of Treatment-Emergent Adverse Reactions in Controlled Studies
|
Placebo |
DEXILANT
30 mg |
DEXILANT
60 mg |
DEXILANT
Total |
Lansoprazole
30 mg |
| Adverse Reaction |
(N=896)
% |
(N=455)
% |
(N=2218)
% |
(N=2621)
% |
(N=1363)
% |
| Diarrhea |
2.9 |
5.1 |
4.7 |
4.8 |
3.2 |
| Abdominal Pain |
3.5 |
3.5 |
4.0 |
4.0 |
2.6 |
| Nausea |
2.6 |
3.3 |
2.8 |
2.9 |
1.8 |
| Upper Respiratory Tract Infection |
0.8 |
2.9 |
1.7 |
1.9 |
0.8 |
| Vomiting |
0.8 |
2.2 |
1.4 |
1.6 |
1.1 |
| Flatulence |
0.6 |
2.6 |
1.4 |
1.6 |
1.2 |
Adverse Reactions Resulting in Discontinuation
In controlled clinical studies, the most common adverse reaction leading to discontinuation from DEXILANT therapy was diarrhea (0.7%).
Other Adverse Reactions
Other adverse reactions that were reported in controlled studies at an incidence of less than 2% are listed below by body system:
Blood and Lymphatic System Disorders: anemia, lymphadenopathy
Cardiac Disorders: angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitation, tachycardia
Ear and Labyrinth Disorders: ear pain, tinnitus, vertigo
Endocrine Disorders: goiter
Eye Disorders: eye irritation, eye swelling
Gastrointestinal Disorders: abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett's esophagus, bezoar, bowel sounds abnormal, breath odor, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, nausea and vomiting, oral mucosal blistering, painful defecation, proctitis, paresthesia oral, rectal hemorrhage
General Disorders and Administration Site Conditions: adverse drug reaction, asthenia, chest pain, chills, feeling abnormal, inflammation, mucosal inflammation, nodule, pain, pyrexia
Hepatobiliary Disorders: biliary colic, cholelithiasis, hepatomegaly
Immune System Disorders: hypersensitivity
Infections and Infestations: candida infections, influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, viral infection, vulvo-vaginal infection
Injury, Poisoning and Procedural Complications: falls, fractures, joint sprains, overdose, procedural pain, sunburn
Laboratory Investigations: ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, blood glucose increased, blood potassium increased, liver function test abnormal, platelet count decreased, total protein increased, weight increase
Metabolism and Nutrition Disorders: appetite changes, hypercalcemia, hypokalemia
Musculoskeletal and Connective Tissue Disorders: arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia
Nervous System Disorders: altered taste, convulsion, dizziness, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia
Psychiatric Disorders: abnormal dreams, anxiety, depression, insomnia, libido changes
Renal and Urinary Disorders: dysuria, micturition urgency
Reproductive System and Breast Disorders: dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder
Respiratory, Thoracic and Mediastinal Disorders: aspiration, asthma, bronchitis, cough, dyspnoea, hiccups, hyperventilation, respiratory tract congestion, sore throat
Skin and Subcutaneous Tissue Disorders: acne, dermatitis, erythema, pruritis, rash, skin lesion, urticaria
Vascular Disorders: deep vein thrombosis, hot flush, hypertension
Additional adverse reactions that were reported in a long-term uncontrolled study and were considered related to DEXILANT by the treating physician included: anaphylaxis, auditory hallucination, B-cell lymphoma, bursitis, central obesity, cholecystitis acute, decreased hemoglobin, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, gastrointestinal pain, gout, herpes zoster, hyperglycemia, hyperlipidemia, hypothyroidism, increased neutrophils, MCHC decrease, neutropenia, oral soft tissue disorder, polydipsia, polyuria, rectal tenesmus, restless legs syndrome, somnolence, thrombocythemia, tonsillitis.
Other adverse reactions not observed with DEXILANT, but occurring with the racemate lansoprazole can be found in the lansoprazole package insert, ADVERSE REACTIONS section.
Postmarketing Experience
Adverse reactions have been identified during post-approval of DEXILANT. As these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye Disorders: blurred vision
Gastrointestinal Disorders: oral edema
General Disorders and Administration Site Conditions: facial edema
Immune System Disorders: anaphylactic shock (requiring emergency intervention), Stevens-Johnsons syndrome, toxic epidermal necrolysis (some fatal)
Respiratory, Thoracic and Mediastinal Disorders: pharyngeal edema, throat tightness
Skin and Subcutaneous Tissue Disorders: generalized rash, leucocytoclastic vasculitis
|
