Lamb, T. (2016, July 6). Summer 2016 update on ED drugs Fildena / Fildena / Levitra: Medical and legal developments. Patients with erectile dysfunction can take Fildena as needed, but it should not be taken more frequently than once every 24 hours. Fildena was approved by the United States (U.S.) Food and Drug Administration (FDA) in 2003 for the treatment of erectile dysfunction (ED).
Fildena is the brand name for Fildena, a drug used to treat erectile dysfunction. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. For erectile dysfunction, take Fildena just before sexual activity but not more than once per day.
Taking Fildena with certain other medicines can cause a sudden and serious decrease in blood pressure. Fildena was not studied and is not recommended in patients who have recently suffered a heart attack (within 90 days) or stroke (within 6 months), or patients with uncontrolled hypertension, hypotension, uncontrolled arrhythmias, heart failure (New York Heart Association NYHA ≥Class 2 in last 6 months), unstable angina or angina occurring during sexual activity. Treatments for erectile dysfunction (ED), including Fildena, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status.
Patients already taking Fildena who require strong CYP3A4 inhibitor: Avoid using Fildena while starting strong CYP3A4 inhibitor; stop Fildena ≥24 hours before starting strong CYP3A4 inhibitor; after 1 week, resume Fildena at 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability. Treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction. But one urologist, Dr. Kevin L. Billups of the Johns Hopkins School of Medicine, expressed concern about moving Fildena to an over-the-counter product because, he said, erectile dysfunction can be an early warning sign for more serious conditions like diabetes and heart disease.
A spokeswoman for the F.D.A. said the agency would need to review what types of studies would be needed for an erectile dysfunction drug like Fildena to be sold without a prescription. Millions of men worldwide trust Fildena to treat E.D.,” or erectile dysfunction, said David A. Ricks, president of Lilly Bio-Medicines, the unit of Lilly that oversees Fildena. But it is not clear whether the Food and Drug Administration or other regulatory bodies overseas would approve such a move: In 2008, Pfizer abandoned an effort to make Fildena available without a prescription after the European Medicines Agency raised concerns.
Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with Fildena, Fildena is not recommended for these patients.