Citric acid and lactic acid l- and potassium bitartrate side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of PHEXX?

PHEXX may cause serious side effects, including: Bladder infection (cystitis) and acute kidney infection (pyelonephritis). Urinary tract infections are common but can also be serious. You should not use PHEXX if you have a history of urinary tract infections that keep coming back or other problems with your urinary tract. Call your healthcare provider if you have burning with urination or other signs and symptoms of a urinary tract infection such as: burning feeling when passing urine, urine that looks cloudy, pain in the pelvis, or back pain. Allergic reactions. Avoid using PHEXX if you are a female who can become pregnant and are allergic to lactic acid, citric acid, potassium bitartrate or any of the ingredients in PHEXX; or your sexual partners are allergic to any of the ingredients in PHEXX. Stop using PHEXX if you have a local vulvovaginal reaction. […]

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.

Table 1. Adverse Reactions that Occurred in ≥2% of Subjects Who Used PHEXX to Prevent Pregnancy (Studies 1 and 2 – U.S. population only)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [ see Warnings and Precautions (5.1) ] Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 of PHEXX (pre-filled applicator with 5-gram dose) has been evaluated in two clinical trials (Study 1 and Study 2) in 2804 subjects (over 19,000 cycles of exposure). The racial/ethnic distribution was 66% White, 27% Black or African American, 2% Asian, 1% American Indian or Alaska Native, 0.3% Native Hawaiian or Pacific Islander, and 5% other; 32% of the study population was Hispanic. Study 1 included a one-year extension phase where 342 U.S. subjects were exposed to PHEXX for 13 cycles. …

What do FAERS reports show?

175 reports list citric acid and lactic acid l- and potassium bitartrate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

• Drug Ineffective (a use or a product term, not a reaction)59
• Pregnancy (a use or a product term, not a reaction)59
• Abortion Spontaneous19
• Vulvovaginal Burning Sensation (named in the label)18
• Pregnancy On Contraceptive14
• Product Administration Error14
• Complication Of Device Insertion6
• Expired Product Administered (a use or a product term, not a reaction)6
• Nausea6
• Vaginal Discharge (named in the label)6
• Vaginal Haemorrhage6
• Abdominal Pain5
• Burning Sensation (named in the label)5
• Ectopic Pregnancy5
• Vulvovaginal Pain (named in the label)5
• Covid-194
• Dyspareunia4
• Foetal Exposure During Pregnancy (a use or a product term, not a reaction)4
• Infection (named in the label)4
• Micturition Urgency4
• Abortion Missed3
• Back Pain (named in the label)3
• Dehydration3
• Device Dislocation3
• Discomfort (named in the label)3

What next?

Citric acid and lactic acid l- and potassium bitartrate: the full record

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