Safely Treating Molluscum Using YCANTH (FDA) – 9/13/23

Safely Treating Molluscum Using YCANTH™

Recommendation Issued by the FDA

The FDA has issued two consumer updates since June 2023, focusing on the management of Molluscum Contagiosum. The first FDA alert was issued in June 2023, and an updated alert was published following the approval of YCANTH in August.

Below is the full text of the consumer update published by the FDA on August 23, 2023:

View Full FDA Article

FDA Article Highlights

“Safely Treating Molluscum, a Common Skin Condition”

If you’re bothered by bumps on your skin, don’t try to diagnose yourself or treat your condition with products that haven’t been approved by the U.S. Food and Drug Administration. Instead, visit a health care professional for a proper diagnosis and to make a treatment plan.

One common condition that some people try to self-diagnose and treat is molluscum contagiosum, a skin infection caused by a virus. But by doing so, you run the risk of delaying the diagnosis and treatment of a potentially more serious condition. And you might do more harm than good.

There is only one FDA-approved treatment for molluscum, called Ycanth (cantharidin), which must be administered by a health care professional. The FDA has not approved any nonprescription products to treat molluscum.

Symptoms and Causes of Molluscum

Molluscum, also called water warts, is a common, benign, viral infection that can cause white, pink, or flesh-colored bumps. These growths can happen alone or in groups almost anywhere on the skin, including the face, neck, arms, legs, abdomen, and genital area. The bumps are rarely on the palms of the hands or soles of the feet.

Sometimes the bumps itch and get irritated. People with a weakened immune system may have larger or more bumps. If you don’t have the condition evaluated by a health care professional, you won’t know if the bumps are molluscum or a symptom of another skin ailment.

Molluscum is an infection common in children, although teens and adults can also get it. Molluscum is transmitted by skin-to-skin contact, including sexual contact, and can be transmitted by sharing clothes or infected objects such as sports equipment. Good hygiene (cleanliness) and avoiding direct contact with bumps are the best ways to avoid getting molluscum. This includes washing your hands, keeping hands, clothes, and equipment clean, and covering bumps if you have them.

Molluscum eventually goes away on its own without treatment, typically within six to 12 months, but sometimes up to five years.

If you have molluscum, a skin doctor (dermatologist) or other health care professional can evaluate your symptoms and recommend ways to manage your condition.

Safely Treating Molluscum

The FDA has approved Ycanth (cantharidin) for the topical (used on the skin) treatment of molluscum in adults and children ages 2 and older. Ycanth, the first FDA-approved treatment for molluscum, is administered to patients only by health care professionals. Providers apply a single application of Ycanth on the areas of patients’ skin with molluscum bumps every three weeks as needed.

Do not purchase or use nonprescription (over-the-counter, or OTC) products that claim to treat molluscum, even if the companies make statements that suggest their product may have been reviewed or is endorsed by the FDA. Some companies may mislead consumers by saying their product is “FDA-approved,” is “FDA registered,” is made in an “FDA-registered facility,” or “complies with FDA Current Good Manufacturing Practices” (or “CGMPs”).

It’s likely that unapproved products marketed to treat molluscum do not do what they claim, and the ingredients in them could cause adverse effects (bad reactions). The FDA has received reports of side effects in children and adults associated with some of these products, including skin reddening, abrasion from skin scratching, and permanent scarring.

Many unapproved products claiming to treat molluscum contain essential oils. Even natural substances, such as essential oils, may cause an allergic reaction or irritate sensitive skin.1

YCANTH Indication and Important Safety Information

INDICATION

YCANTH (cantharidin) topical solution, 0.7% is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS:

  • YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Life threatening or fatal toxicities can occur if YCANTH is administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes. If YCANTH gets in eyes, flush eyes with water for at least 15 minutes.

    • Local Skin Reactions: Reactions at the application site may occur, including vesiculation, pruritus, pain, discoloration, and erythema. Avoid application near eyes and mucosal tissue, and to healthy skin. If YCANTH contacts any unintended surface, or healthy skin, immediately remove. If severe local skin reactions occur, remove prior to the recommended 24 hours after treatment.

    • YCANTH is flammable, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed.

 

ADVERSE REACTIONS:

The most common (incidence ≥1%) reactions are the following local skin reactions at the application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during clinical trials. These local skin reactions are expected and related to the anticipated blistering response of the skin to cantharidin.

 

DRUG INTERACTIONS:

No studies evaluating the drug interaction potential of cantharidin have been conducted.

USE IN SPECIFIC POPULATIONS:

Pregnancy: There are no available data with use of YCANTH in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug.

Lactation: Avoid application of YCANTH topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child.

 

OVERDOSAGE:

Oral ingestion of cantharidin has resulted in renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis.

 

Please see full Prescribing Information.

 

To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc. at 1-877-VERRICA (1-877-837-7422), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Local skin reactions are expected and should be reported if they are severe.

Sources:

1.“FDA Has Not Approved Any Nonprescription Products to Treat Molluscum.” U.S. Food and Drug Administration, August 23, 2023. https://www.fda.gov/consumers/consumer-updates/safely-treating-molluscum-common-skin-condition.