Important DHEA Safety Information
Important Safety Information for Vaginal DHEA Products
Please carefully read the following safety information regarding your prescription of vaginal DHEA products:
Risks and Precautions:
- Vaginal DHEA is intended for local use in the vaginal tissues and may help support vaginal health and comfort in appropriate patients experiencing symptoms related to perimenopause or menopause.
- Vaginal DHEA may not be appropriate for individuals with unexplained vaginal bleeding or a history of hormone-sensitive cancers.
- Notify your healthcare provider immediately if you experience unexpected vaginal bleeding, new breast changes, severe vaginal irritation, persistent pelvic pain, or other concerning symptoms.
Usage Guidelines:
- Take your medication exactly as prescribed by your healthcare provider.
- Do not share your medication with others.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential interactions.
Off Label:
- The use of these compounded medications for this indication is off-label.
- For any questions or concerns regarding your medication, contact our support team immediately.
This statement does not replace individual medical advice provided by your healthcare professional. Always follow the specific instructions given by your provider.
Important Vaginal DHEA Safety Information
Safety Information
- Vaginal DHEA is converted within the body into small amounts of estrogen and testosterone.
- Patients with a history of hormone-sensitive cancers should discuss the potential risks and benefits of treatment with their healthcare provider before starting therapy.
- Vaginal DHEA has not been adequately studied in patients with a history of hormone-sensitive cancers.
- Vaginal DHEA should not be used in patients with unexplained vaginal bleeding until an appropriate evaluation has been completed.
- Any persistent or recurring vaginal bleeding should be reported to your healthcare provider promptly.
What is the FDA-approved use of vaginal DHEA?
Vaginal DHEA is approved by the FDA for the treatment of moderate to severe pain during sexual intercourse (dyspareunia) associated with menopause-related changes in the vaginal tissues.
Who should not use vaginal DHEA?
You should not use vaginal DHEA if you:
- Have unexplained vaginal bleeding that has not been evaluated by a healthcare provider
- Have a known allergy to DHEA or any ingredient in the formulation
- Are pregnant or breastfeeding
How should vaginal DHEA be administered?
Vaginal DHEA is administered locally within the vagina, typically once daily at bedtime. It is intended to work primarily within the vaginal tissues rather than throughout the entire body.
What should I tell my Ivim provider before starting vaginal DHEA?
It is important to tell your Ivim provider about all prescription medications, over-the-counter medications, vitamins, herbal supplements, and hormone therapies you are currently taking.
Medications to watch out for (interactions): Please note, this is not an exhaustive list, and interactions are not limited to the following medications.
- Aromatase inhibitors (such as anastrozole, letrozole, or exemestane)
- Tamoxifen
- Fulvestrant
- Estrogen-containing therapies
- Testosterone therapy
- Antidepressant medications
- Blood-thinning medications (including anticoagulants and antiplatelet medications)
Most reported drug interactions involving DHEA are based on studies of oral DHEA supplements, which usually result in significantly higher systemic DHEA levels than vaginal DHEA therapy. Vaginal DHEA may increase systemic DHEA levels slightly, but blood levels typically remain low.
Patients should discuss all medications, supplements, and hormone therapies with their healthcare provider before starting vaginal DHEA.
It is important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:
- Hormone-sensitive cancers
- Current or prior treatment with tamoxifen, aromatase inhibitors, fulvestrant, or other therapies for hormone-sensitive cancers
- Unexplained vaginal bleeding
- Abnormal uterine bleeding
- Endometrial hyperplasia
- Abnormal Pap smears
- Current hormone therapy use
- Pregnancy or breastfeeding
What are the most serious side effects that I or a caregiver should monitor for?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
The following side effects should be reported promptly to your healthcare provider:
Unexpected Vaginal Bleeding – Any persistent, recurring, or unexplained vaginal bleeding should be promptly evaluated by a healthcare provider.
New Breast Changes – Report any new breast lumps, nipple discharge, breast pain, or other concerning breast changes to your healthcare provider.
Persistent Pelvic Pain or Severe Vaginal Irritation – Report symptoms that are severe, worsening, or do not improve with continued treatment.
What are the most common side effects of vaginal DHEA?
- Vaginal discharge
- Vaginal irritation or discomfort
- Vaginal spotting
- Abnormal Pap smear findings
In clinical studies, abnormal Pap smear findings occurred in approximately 2% of patients after one year of treatment. Most of these findings were minor cellular changes commonly seen during routine cervical cancer screening and did not indicate cervical cancer. Patients should continue routine gynecologic care and cervical cancer screening as recommended by their healthcare provider.
Disclaimer:
Vaginal DHEA is available as a compounded medication through licensed compounding pharmacies. Compounded medications are not FDA-approved but are prepared by pharmacists to meet individual patient needs based on a valid prescription. The safety, efficacy, and quality of compounded vaginal DHEA may vary depending on the pharmacy and formulation.
Always consult with a licensed healthcare provider before starting any compounded therapy.
This document may include information about the use of medications, supplements, or therapies that are not approved by the U.S. Food and Drug Administration (FDA) for the specific indication discussed. Such “off-label” use is based on clinical judgment, emerging research, or standard of care guidelines and is intended to support safe, evidence-informed decision-making.
