5.2 Potential Risk for Carcinogenicity

 

Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives which are structurally related to secnidazole. It is unclear if the positive tumor findings in lifetime rodent studies of these nitroimidazoles indicate a risk to patients taking a single dose of SOLOSEC to treat bacterial vaginosis. Avoid chronic use of SOLOSEC [see Nonclinical Toxicology (13.1)] 

5.3 Drug Resistance

 

Prescribing SOLOSEC in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

 

6 ADVERSE REACTIONS 

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.

 

The safety data described below reflect exposure to 589 patients, of whom 518 received a 2 g dose of SOLOSEC. SOLOSEC was eva luated in three clinical trials of patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and one uncontrolled safety trial (Trial 3 n=321).

 

All patients received a single oral dose of study medication or placebo. Trial 1 eva luated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of SOLOSEC. Trial 2 eva luated a 2 g dose (n=125). The population was female, aged 15 to 54 years. Patients in the placebo- controlled trials were primarily Black or African American (54%) or Caucasian (41%).

 

There were no deaths in the trials. Two patients in Trial 3 discontinued due to vulvovaginal candidiasis in the SOLOSEC-treated arm.

 

Most Common Adverse Reactions 

Among 197 patients treated with a single 2 g dose of SOLOSEC in the two placebo-controlled trials, Trial 1 and 2, adverse reactions were reported by approximately 29% of patients. Table 1 displays the most common adverse reactions (≥ 2 % in SOLOSEC-treated patients) in these two trials.

Table 1: Adverse Reactions Occurring (≥ 2 % SOLOSEC-Treated Patients) in the Pooled Placebo-Controlled Trials 1 and 2 in Adult Women with Bacterial Vaginosis 

Adverse Reaction

 

SOLOSEC

N=197

n (%)

 

Placebo

N=136

n (%)

    Vulvo-vaginal candidiasis 19 (9.6) 4 (2.9) 

    Headache 7 (3.6) 2 (1.5) 

    Nausea 7 (3.6) 1 (0.7) 

    Diarrhea 5 (2.5) 1 (0.7) 

    Abdominal pain 4 (2.0) 2 (1.5) 

    Vulvovaginal pruritus 4 (2.0) 2 (1.5) 

Among the 321 patients in an uncontrolled trial, Trial 3, adverse reactions were reported in 30% of patients. Vulvovaginal candidiasis (8.4%), nausea (5.3%), vomiting (2.5%) and dysgeusia (3.4%) were the most common adverse reactions reported in this trial.

6.2 Postmarketing Experience