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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
SOLOSEC (NDA-209363)
(SECNIDAZOLE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
01/26/2022 (SUPPL-14)
6 Adverse Reactions
6.1 Clinical Trials Experience
Bacterial Vaginosis
Additions and/or revisions underlined:
The safety data described below reflect exposure to 629 patients, of whom 558 received a 2 g dose of SOLOSEC. SOLOSEC was evaluated in four clinical trials of female patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and two uncontrolled safety trials (Trial 3 n=321, Trial 4 n=40).
Most Common Adverse Reactions in Trials 1 and 2
All patients in Trial 1 and Trial 2 received a single oral dose of study medication or placebo. Trial 1 evaluated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of SOLOSEC in patients aged 18 to 54 years. Trial 2 evaluated a 2 g dose (n=125)in patients aged 15 to 54 years. Patients in the placebo-controlled trials were primarily Black or African American (54%) or Caucasian (41%).
Most Common Adverse Reactions in Trial 3
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. Two SOLOSEC-treated patients in Trial 3 discontinued due to vulvovaginal candidiasis.
Most Common Adverse Reactions in Trial 4
In Trial 4, the safety of SOLOSEC was evaluated in a multicenter, uncontrolled, open-label study evaluating the safety and tolerability of SOLOSEC in 40 pediatric patients between the ages of 12 and less than 18 years old all of whom were treated with a 2 g single dose of SOLOSEC. Most patients in this study were either White (60%) or Black/African-American (38%).The overall safety findings of a SOLOSEC 2 g dose in patients aged 12 to 17 years are consistent with findings in adult patients aged 18 to 65 years old. There were no deaths, severe adverse reactions, or discontinuations due to adverse reactions. Adverse reactions occurring in at least one SOLOSEC-treated pediatric patient included: nausea and abdominal pain.
Trichomoniasis
The safety of SOLOSEC was evaluated in 147 female patients with trichomoniasis who participated in Trial 5, a placebo controlled, double blind trial, of whom 143 (97.3%) patients completed the ‘Test of Cure’ (TOC) visit. In this trial, 74 patients received a single 2-gram oral dose of SOLOSEC, and 73 patients received placebo. The mean age of the patients in this study was 37.7 years, with a range of 15 to 65 years. Most of the patients were Black or African American (134/147; 91.2%). In the primary phase of Trial 5, i.e., baseline to TOC visit, one SOLOSEC-treated patient was discontinued from the study due to nausea and productive cough.
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of SOLOSEC for the treatment of bacterial vaginosis have been established in pediatric patients aged 12 to 17 years old. Use of SOLOSEC in this age group is supported by evidence from a multicenter, open-label safety study in 40 pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1)] and evidence from adequate and well-controlled studies in adult women [see Clinical Studies (14.1)].
The safety and effectiveness of SOLOSEC for the treatment of trichomoniasis have been established in pediatric patients aged 12 to 17 years old. Use of SOLOSEC in this group is based on the extrapolation of clinical trial data from adult women with trichomoniasis, four open-label trials in males with trichomoniasis, and an open-label safety study in pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1) and Clinical Studies (14.2)].The safety and effectiveness of SOLOSEC in pediatric patients below the age of 12 years have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
What is SOLOSEC?
SOLOSEC is a prescription medicine used to treat:
- bacterial vaginal infections in females 12 years of age and older.
- trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older.
General information about the safe and effective use of SOLOSEC.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOLOSEC for a condition for which it was not prescribed. Do not give SOLOSEC to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SOLOSEC that is written for health professionals.
01/26/2022 (SUPPL-16)
6 Adverse Reactions
6.1 Clinical Trials Experience
Bacterial Vaginosis
Additions and/or revisions underlined:
The safety data described below reflect exposure to 629 patients, of whom 558 received a 2 g dose of SOLOSEC. SOLOSEC was evaluated in four clinical trials of female patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and two uncontrolled safety trials (Trial 3 n=321, Trial 4 n=40).
Most Common Adverse Reactions in Trials 1 and 2
All patients in Trial 1 and Trial 2 received a single oral dose of study medication or placebo. Trial 1 evaluated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of SOLOSEC in patients aged 18 to 54 years. Trial 2 evaluated a 2 g dose (n=125)in patients aged 15 to 54 years. Patients in the placebo-controlled trials were primarily Black or African American (54%) or Caucasian (41%).
Most Common Adverse Reactions in Trial 3
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. Two SOLOSEC-treated patients in Trial 3 discontinued due to vulvovaginal candidiasis.
Most Common Adverse Reactions in Trial 4
In Trial 4, the safety of SOLOSEC was evaluated in a multicenter, uncontrolled, open-label study evaluating the safety and tolerability of SOLOSEC in 40 pediatric patients between the ages of 12 and less than 18 years old all of whom were treated with a 2 g single dose of SOLOSEC. Most patients in this study were either White (60%) or Black/African-American (38%).The overall safety findings of a SOLOSEC 2 g dose in patients aged 12 to 17 years are consistent with findings in adult patients aged 18 to 65 years old. There were no deaths, severe adverse reactions, or discontinuations due to adverse reactions. Adverse reactions occurring in at least one SOLOSEC-treated pediatric patient included: nausea and abdominal pain.
Trichomoniasis
The safety of SOLOSEC was evaluated in 147 female patients with trichomoniasis who participated in Trial 5, a placebo controlled, double blind trial, of whom 143 (97.3%) patients completed the ‘Test of Cure’ (TOC) visit. In this trial, 74 patients received a single 2-gram oral dose of SOLOSEC, and 73 patients received placebo. The mean age of the patients in this study was 37.7 years, with a range of 15 to 65 years. Most of the patients were Black or African American (134/147; 91.2%). In the primary phase of Trial 5, i.e., baseline to TOC visit, one SOLOSEC-treated patient was discontinued from the study due to nausea and productive cough.8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of SOLOSEC for the treatment of bacterial vaginosis have been established in pediatric patients aged 12 to 17 years old. Use of SOLOSEC in this age group is supported by evidence from a multicenter, open-label safety study in 40 pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1)] and evidence from adequate and well-controlled studies in adult women [see Clinical Studies (14.1)].
The safety and effectiveness of SOLOSEC for the treatment of trichomoniasis have been established in pediatric patients aged 12 to 17 years old. Use of SOLOSEC in this group is based on the extrapolation of clinical trial data from adult women with trichomoniasis, four open-label trials in males with trichomoniasis, and an open-label safety study in pediatric female patients with bacterial vaginosis [see Adverse Reactions (6.1) and Clinical Studies (14.2)].The safety and effectiveness of SOLOSEC in pediatric patients below the age of 12 years have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
What is SOLOSEC?
SOLOSEC is a prescription medicine used to treat:
bacterial vaginal infections in females 12 years of age and older.
- trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older.
General information about the safe and effective use of SOLOSEC.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOLOSEC for a condition for which it was not prescribed. Do not give SOLOSEC to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SOLOSEC that is written for health professionals.
12/15/2021 (SUPPL-17)
4 Contraindications
Additions underlined
SOLOSEC is contraindicated:
In patients who have shown hypersensitivity to secnidazole, or other nitroimidazole derivatives.
In patients with Cockayne syndrome: Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to secnidazole, in patients with Cockayne syndrome [see Adverse Reactions (6.2)].
6 Adverse Reactions
6.2 Postmarketing ExperienceAdditions underlined
The following adverse reactions have been reported during use of SOLOSEC and other 2 g formulations of secnidazole outside of the United States or other nitroimidazole agents.
…
SOLOSEC
Nervous System Disorders: Dysgeusia
Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. [see Dosage and Administration (2.3), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
Metronidazole, Another Nitroimidazole Agent, Structurally Related to Secnidazole Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after initiation of systemic use of metronidazole, another nitroimidazole agent structurally related to secnidazole, have been reported in patients with Cockayne syndrome (latency from drug start to signs of liver failure as short as 2 days) [see Contraindications (4)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATIONAdditions underlined
…
Do not take SOLOSEC if you:
• are allergic to secnidazole or other nitroimidazole medicines.
• have Cockayne syndrome.
…
06/30/2021 (SUPPL-12)
5 Warnings and Precautions
5.1 Vulvovaginal Candidiasis
(Additions and/or revisions are underlined)
The use of SOLOSEC may result in vulvovaginal candidiasis. In controlled clinical trials of non- pregnant women with bacterial vaginosis, vulvovaginal candidiasis developed in 19/197 (9.6%) of patients who received 2 g SOLOSEC and 4/136 (2.9%) subjects who received placebo. In a controlled clinical trial of non-pregnant women with trichomoniasis, vulvovaginal candidiasis developed in 2/74 (2.7%) of patients who received 2 g SOLOSEC and 0/73 (0%) subjects who received placebo [see Adverse Reactions (6.1)]. Symptomatic vulvovaginal candidiasis may require treatment with an antifungal agent.
6 Adverse Reactions
(Additions and/or revisions are underlined)
The following important adverse reactions are discussed in greater detail in other sections of labeling:
- Vulvovaginal Candidiasis [Warnings and Precautions (5.1)]
6.1 Clinical Trials Experience
(Additions and/or revisions are underlined)
Trichomoniasis
The safety of SOLOSEC was evaluated in 147 female patients with trichomoniasis who participated in Trial 4, a placebo controlled, double blind trial, of whom 143 (97.3%) patients completed the ‘Test of Cure’ (TOC) visit. In this trial, 74 patients received a single 2-gram oral dose of SOLOSEC and 73 patients received placebo. The population who received SOLOSEC consisted of adult female patients, aged 19 to 65 years. Most of the patients were Black or African American (134/147; 91.2%). In the primary phase of Trial 4, i.e., baseline to TOC visit, one SOLOSEC-treated patient was discontinued from the study due to nausea and productive cough.
Most Common Adverse Reactions
A total of 11 patients (14.9%) who received SOLOSEC and 16 patients (21.9%) in the placebo group reported adverse reactions, respectively. Vulvovaginal candidiasis was reported in 2 patients (2.7%) in the SOLOSEC group and in none of the patients in the placebo group.
6.2 Postmarketing Experience
(Additions and/or revisions are underlined)
The following adverse reactions have been reported during use of SOLOSEC and other 2 g formulations of secnidazole outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System Disorders: Dysgeusia
Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. [see Dosage and Administration (2.3), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
7 Drug Interactions
7.2 Alcohol
(Newly Added Subsection)
Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during SOLOSEC therapy and for 2 days after treatment is stopped.
Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol [see Dosage and Administration (2.3), Adverse Reactions (6.2) and Clinical Pharmacology (12.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Administration Instructions
Instruct the patient:
To sprinkle the entire contents of the packet of SOLOSEC onto applesauce, yogurt or pudding and take all the mixture within 30 minutes without chewing or crunching the granules.
That after consuming the mixture, they may take a glass of water to aid in swallowing.
That SOLOSEC is not intended to be dissolved in any liquid.
Advise the patient that SOLOSEC may be taken without regard to the timing of meals.
Vulvovaginal Candidiasis
Advise the patient that use of SOLOSEC may result in vulvovaginal candidiasis that may require treatment with an antifungal agent. [see Warnings and Precautions (5.1)]
Alcohol
Advise patients to avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during SOLOSEC therapy and for 2 days afterward because nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache may occur [see Dosage and Administration (2.3), Adverse Reactions (6.2), Drug Interactions (7.2), and Clinical Pharmacology (12.3)].
06/14/2021 (SUPPL-15)
5 Warnings and Precautions
Additions and/or revisions underlined:
5.3 Risk of Development of Drug Resistance
Prescribing SOLOSEC in the absence of proven …
6 Adverse Reactions
Postmarketing ExperienceAdditions and/or revisions underlined:
The following adverse reactions have been reported during use of SOLOSEC and other formulations of secnidazole 2 g outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. [see Dosage and Administration (2.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
7 Drug Interactions
Newly added subsection:
7.2 Alcohol
Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during SOLOSEC therapy and for 2 days after treatment is stopped.
Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. [see Dosage and Administration (2.2), Adverse Reactions (6.2) and Clinical Pharmacology (12.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and/or revisions underlined:
Vulvo-Vaginal Candidiasis
Advise the patient that use of SOLOSEC may result in vulvo-vaginal candidiasis that may require treatment with an antifungal agent. [see Warnings and Precautions (5.1)]
Alcohol
Advise patients to avoid consumption of alcoholic beverages and preparations containing ethanol or propylene glycol during SOLOSEC therapy and for 2 days afterward because nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache may occur [see Dosage and Administration (2.2), Adverse Reactions (6.2), Drug Interactions (7.2), and Clinical Pharmacology (12.3)].
Newly added information:
What should I avoid while taking SOLOSEC?
Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC because the following side effects may happen:
nausea
diarrhea
dizziness
vomiting
stomach (abdominal) pain
headache