ADVERSE REACTIONS
The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg FLOMAX capsules were used. These studies evaluated safety in 1783 patients treated with FLOMAX capsules and 798 patients administered placebo. Table 3 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either FLOMAX capsules 0.4 mg, or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials (US92-03A and US93-01) conducted in 1487 men.
Table 3 Treatment-Emergent1 Adverse Events Occurring in ≥2% of Flomax® (tamsulosin hydrochloride) Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies BODY SYSTEM/
ADVERSE EVENT | FLOMAX CAPSULES GROUPS | PLACEBO |
| | 0.4 mg
n=502 | 0.8 mg
n=492 |
n=493 |
- 1A treatment-emergent adverse event was defined as any event satisfying one of the following criteria:
- The adverse event occurred for the first time after initial dosing with double-blind study medication.
- The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind treatment; or
- The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and then reappeared during double-blind treatment.
2Coding preferred terms also include cold, common cold, head cold, flu, and flu-like symptoms.
3Coding preferred terms also include nasal congestion, stuffy nose, runny nose, sinus congestion, and hay fever.
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| BODY AS WHOLE | | | |
| Headache | 97 (19.3%) | 104 (21.1%) | 99 (20.1%) |
| Infection2 | 45 (9.0%) | 53 (10.8%) | 37 (7.5%) |
| Asthenia | 39 (7.8%) | 42 (8.5%) | 27 (5.5%) |
| Back pain | 35 (7.0%) | 41 (8.3%) | 27 (5.5%) |
| Chest Pain | 20 (4.0%) | 20 (4.1%) | 18 (3.7%) |
| NERVOUS SYSTEM | | | |
| Dizziness | 75 (14.9%) | 84 (17.1%) | 50 (10.1%) |
| Somnolence | 15 (3.0%) | 21 (4.3%) | 8 (1.6%) |
| Insomnia | 12 (2.4%) | 7 (1.4%) | 3 (0.6%) |
| Libido Decreased | 5 (1.0%) | 10 (2.0%) | 6 (1.2%) |
RESPIRATORY
SYSTEM | | | |
| Rhinitis3 | 66 (13.1%) | 88 (17.9%) | 41 (8.3%) |
| Pharyngitis | 29 (5.8%) | 25 (5.1%) | 23 (4.7%) |
| Cough Increased | 17 (3.4%) | 22 (4.5%) | 12 (2.4%) |
| Sinusitis | 11 (2.2%) | 18 (3.7%) | 8 (1.6%) |
| DIGESTIVE SYSTEM | | | |
| Diarrhea | 31 (6.2%) | 21 (4.3%) | 22 (4.5%) |
| Nausea | 13 (2.6%) | 19 (3.9%) | 16 (3.2%) |
| Tooth Disorder | 6 (1.2%) | 10 (2.0%) | 7 (1.4%) |
| UROGENITAL SYSTEM | | | |
| Abnormal Ejaculation | 42 (8.4%) | 89 (18.1%) | 1 (0.2%) |
| SPECIAL SENSES | | | |
| Blurred vision | 1 (0.2%) | 10 (2.0%) | 2 (0.4%) |
Signs and Symptoms of Orthostasis: In the two U.S. studies, symptomatic postural hypotension was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group, and by no patients in the placebo group. Syncope was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group and 0.6% of patients (3 of 493) in the placebo group. Dizziness was reported by 15% of patients (75 of 502) in the 0.4 mg group, 17% of patients (84 of 492) in the 0.8 mg group, and 10% of patients (50 of 493) in the placebo group. Vertigo was reported by 0.6% of patients (3 of 502) in the 0.4 mg group, 1% of patients (5 of 492) in the 0.8 mg group and by 0.6% of patients (3 of 493) in the placebo group.
Multiple testing for orthostatic hypotension was conducted in a number of studies. Such a test was considered positive if it met one or more of the following criteria: (1) a decrease in systolic blood pressure of ≥20 mmHg upon standing from the supine position during the orthostatic tests; (2) a decrease in diastolic blood pressure ≥10 mmHg upon standing, with the standing diastolic blood pressure <65 mmHg during the orthostatic test; (3) an increase in pulse rate of ≥20 bpm upon standing with a standing pulse rate ≥100 bpm during the orthostatic test; and (4) the presence of clinical symptoms (faintness, lightheadedness/lightheaded, dizziness, spinning sensation, vertigo, or postural hypotension) upon standing during the orthostatic test.
Following the first dose of double-blind medication in Study 1, a positive orthostatic test result at 4 hours post-dose was observed in 7% of patients (37 of 498) who received Flomax® (tamsulosin hydrochloride) capsules 0.4 mg once daily and in 3% of the patients (8 of 253) who received placebo. At 8 hours post-dose, a positive orthostatic test result was observed for 6% of the patients (31 of 498) who received FLOMAX capsules 0.4 mg once daily and 4% (9 of 250) who received placebo (Note: patients in the 0.8 mg group received 0.4 mg once daily for the first week of Study 1).
In Studies 1 and 2, at least one positive orthostatic test result was observed during the course of these studies for 81 of the 502 patients (16%) in the FLOMAX capsules 0.4 mg once daily group, 92 of the 491 patients (19%) in the FLOMAX capsules 0.8 mg once daily group and 54 of the 493 patients (11%) in the placebo group.
Because orthostasis was detected more frequently in FLOMAX capsule-treated patients than in placebo recipients, there is a potential risk of syncope (see WARNINGS).
Abnormal Ejaculation: Abnormal ejaculation includes ejaculation failure, ejaculation disorder, retrograde ejaculation and ejaculation decrease. As shown in Table 3, abnormal ejaculation was associated with FLOMAX capsules administration and was dose-related in the U.S. studies. Withdrawal from these clinical studies of FLOMAX capsules because of abnormal ejaculation was also dose-dependent with 8 of 492 patients (1.6%) in the 0.8 mg group, and no patients in the 0.4 mg or placebo groups discontinuing treatment due to abnormal ejaculation.
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of FLOMAX capsules. Because 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. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to FLOMAX capsules. Allergic-type reactions such as skin rash, urticaria, pruritus, angioedema and respiratory symptoms have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of palpitations, hypotension, skin desquamation, constipation and vomiting have been received during the post-marketing period.
During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha-1 blocker therapy (see PRECAUTIONS, General).
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO FLOMAX
Below is a sample of reports where side effects / adverse reactions may be related to Flomax. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Flomax side effects / adverse reactions in 84 year old male
Reported by a physician from United States on 2007-01-08
Patient: 84 year old male
Reactions: Death
Adverse event resulted in: death
Suspect drug(s):
Revlimid
Dosage: 10 mg, 1 in 1 d, oral
Administration route: Oral
Indication: Myelodysplastic Syndrome
Start date: 2006-12-08
Benicar
Indication: Drug USE FOR Unknown Indication
Flomax
Indication: Drug USE FOR Unknown Indication
Possible Flomax side effects / adverse reactions in 46 year old male
Reported by a consumer/non-health professional from United States on 2007-01-08
Patient: 46 year old male
Reactions: Aphasia, Vertigo, Sensory Loss
Adverse event resulted in: hospitalization
Suspect drug(s):
Flomax
Possible Flomax side effects / adverse reactions in 53 year old male
Reported by a consumer/non-health professional from United States on 2007-01-12
Patient: 53 year old male weighing 63.6 kg (139.9 pounds)
Reactions: Jaundice, Anaemia Haemolytic Autoimmune
Suspect drug(s):
Avodart
Dosage: .5mg per day
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Flomax
Dosage: 1tab per day
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
SAW Palmetto
Dosage: 1tab per day
Administration route: Oral
Indication: Benign Prostatic Hyperplasia
Other drugs received by patient: Ascorbic Acid
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