MUSE SIDE EFFECTS
- Generic Name: alprostadil urethral suppository
- Brand Name: Muse
- Drug Class: Prostaglandins, Genitourinary
SIDE EFFECTS
In-Clinic Titration
In the 2 largest double-blind, parallel, placebo-controlled trials, 1511 patients received MUSE at least 1 time in the clinic setting. The most frequently reported drug-related side effects during in-clinic titration included pain in the penis (36%), urethra (13%), or testes (5%). These discomforts were most commonly reported as mild and transient, but about 7% of patients withdrew at this stage because of adverse events. Urethral bleeding/spotting and other minor abrasions to the urethra were reported in approximately 3% of patients. Symptomatic lowering of blood pressure (hypotension) occurred in 3% of patients; in addition, some lowering of blood pressure may occur without symptoms. Dizziness was reported in 4% of patients. Syncope (fainting) was reported by 0.4% of patients.
Home Treatment
996 patients (66% of those who began titration) were studied during the home treatment portion of 2 Phase III placebo-controlled studies. Fewer than 2% of patients discontinued from these studies primarily because of adverse events. The following table summarizes the frequency of adverse events reported by patients using MUSE or placebo.
Adverse Events Reported by ≥2% of Patients Treated with MUSE, and More Common than on Placebo, at Home in Phase III Placebo-Controlled Clinical Studies for up to 3 Months
| Event | MUSE n = 486 |
Placebo n = 511 |
| UROGENITAL SYSTEM | ||
| Penile Pain | 32% | 3% |
| Urethral Burning | 12% | 4% |
| Minor Urethral Bleeding/ Spotting | 5% | 1% |
| Testicular Pain | 5% | 1% |
| NERVOUS SYSTEM | ||
| Dizziness | 2% | <1% |
| BODY AS A WHOLE | ||
| Flu Symptoms | 4% | 2% |
| Headache | 3% | 2% |
| Pain | 3% | 1% |
| Accidental Injury | 3% | 2% |
| Back Pain | 2% | 1% |
| Pelvic Pain | 2% | <1% |
| RESPIRATORY | ||
| Rhinitis | 2% | <1% |
| Infection | 3% | 2% |
Other drug-related side effects observed during in-clinic titration and home treatment include swelling of leg veins, leg pain, perineal pain, and rapid pulse, each occurring in <2% of patients.
Female Partner Adverse Events
The most common drug-related adverse event reported by female partners during placebo-controlled clinical studies was vaginal burning/itching, reported by 5.8% of partners of patients on active vs. 0.8% of partners of patients on placebo. It is unknown whether this adverse event experienced by female partners was a result of the medication or a result of resuming sexual intercourse, which occurred much more frequently in partners of patients on active medication.
To report suspected adverse reactions, contact Meda Pharmaceuticals Inc. at 1-888-345-6873 or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.
SRC: NLM .