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STAXYN (VARDENAFIL): ADVERSE REACTIONS / SIDE EFFECTS

The following serious adverse reactions with the use of Staxyn (Vardenafil) are discussed elsewhere in the labeling:
  • Cardiovascular effects
  • Priapism
  • QT Prolongation
  • Effects on eye
  • Sudden hearing loss

    Clinical Studies Experience

    Because 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.

    Safety of Vardenafil (Staxyn) was evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. In both pivotal studies, enrollment was stratified so that approximately 50% of patients were >= 65 years old. Approximately 8% (n=29) were >= 75 years old. An integrated analysis of both studies included a total of 355 subjects that received Staxyn compared to 340 subjects that received placebo (mean age was 61.7, range 21.0 to 88.0; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other). The discontinuation rates due to adverse reactions were 1.4% for Vardenafil (Staxyn) tablets compared to 0.6% for placebo.

    Adverse drug reactions reported in the Staxyn placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.

    All Vardenafil Studies

    Vardenafil film-coated tablets and Staxyn has been administered to over 17,000 men (mean age 54.5, range 18.89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.

    In the placebo-controlled clinical trials for vardenafil film-coated tablets and Staxyn, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.

    Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, flushing, headache, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.

    The following section identifies additional, less frequent adverse reactions ( < 2%) reported during the clinical development of vardenafil film-coated tablets and Staxyn. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:

    Body as a whole: feeling unwell, allergic edema and angioedema, allergic reactions, chest pain

    Auditory: vertigo, tinnitus

    Cardiovascular: palpitation, angina pectoris, tachycardia, myocardial infarction, hypotension, ventricular tachyarrhythmias

    Digestive: nausea, dry mouth, gastrointestinal and abdominal pain, diarrhea, gastritis, gastroesophageal reflux disease, vomiting, increase in transaminases

    Musculoskeletal: increase in creatine phosphokinase (CPK), myalgia, increased muscle tone and cramping

    Nervous: paresthesia and dysesthesia, sleep disorder, somnolence, syncope, seizure, amnesia

    Respiratory: sinus congestion, dyspnea

    Skin and appendages: rash, erythema

    Ophthalmologic: visual disturbance, visual color distortions, ocular hyperemia, eye pain and eye discomfort, increase in intraocular pressure, photophobia, conjunctivitis

    Urogenital: priapism, increase in erection

    Postmarketing Experience

    The following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

    Ophthalmologic

    Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors.

    Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience. It is not possible to determine whether these events are related directly to the use of vardenafil.

    Neurologic: Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with Staxyn (Vardenafil Hydrochloride) tablets.

    Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.

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