Sildenafil For Oral Suspension (Page 2 of 8)

5.6 Hearing Loss

Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including Sildenafil. In some of the cases, medical conditions and other factors were reported that may have played a role. 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 Sildenafil for Oral Suspension, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.

Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including Sildenafil for Oral Suspension.

5.7 Combination with other PDE-5 inhibitors

Sildenafil is also marketed as VIAGRA®. The safety and efficacy of combinations of Sildenafil for Oral Suspension with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking Sildenafil for Oral Suspension not to take VIAGRA or other PDE-5 inhibitors.

5.8 Priapism

Use Sildenafil for Oral Suspension with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.

5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia

In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received Sildenafil for Oral Suspension than by those randomized to placebo. The effectiveness and safety of Sildenafil for Oral Suspension in the treatment of PAH secondary to sickle cell anemia has not been established.

6 ADVERSE REACTIONS

The following serious adverse events are discussed elsewhere in the labeling:

6.1 Clinical Trials 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 data of Sildenafil for Oral Suspension in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Sildenafil for Oral Suspension-treated patients with PAH, WHO Group I [see Clinical Studies (14)].

The overall frequency of discontinuation in Sildenafil for Oral Suspension-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.

In Study 1, the adverse reactions that were reported by at least 3% of Sildenafil for Oral Suspension-treated patients (20 mg three times a day) and were more frequent in Sildenafil for Oral Suspension-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.

Table 1. Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Sildenafil for Oral Suspension-Treated Patients than Placebo-Treated Patients and Incidence ≥3% in Sildenafil for Oral Suspension-Treated Patients)
Placebo, %(n = 70) Sildenafil for Oral Suspension 20 mg three times a day, %(n = 69) Placebo-Subtracted, %
Epistaxis 1 9 8
Headache 39 46 7
Dyspepsia 7 13 6
Flushing 4 10 6
Insomnia 1 7 6
Erythema 1 6 5
Dyspnea exacerbated 3 7 4
Rhinitis 0 4 4
Diarrhea 6 9 3
Myalgia 4 7 3
Pyrexia 3 6 3
Gastritis 0 3 3
Sinusitis 0 3 3
Paresthesia 0 3 3

At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.

The incidence of retinal hemorrhage with Sildenafil for Oral Suspension 20 mg three times a day was 1.4% versus 0% placebo and for all Sildenafil for Oral Suspension doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for Sildenafil for Oral Suspension versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.

In a placebo-controlled fixed dose titration study (Study 2) of Sildenafil for Oral Suspension (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the Sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].

Table 2. Adverse Reactions (%) in patients with PAH in Study 2 (incidence in Sildenafil + Epoprostenol group at least 6% greater than Epoprostenol group)
Sildenafil + Epoprostenol(n = 134) Epoprostenol(n = 131) (Sildenafil + Epoprostenol) minus Epoprostenol
*
includes peripheral edema
Headache 57 34 23
Edema * 25 13 14
Dyspepsia 16 2 14
Pain in extremity 17 6 11
Diarrhea 25 18 7
Nausea 25 18 7
Nasal congestion 9 2 7

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