FDA Advisory No. 2019-388 || Incorrect Use of Anti-Fungal Corticosteroid Combination Therapy

Nowadays, internet and social media has influenced the lives of Filipinos. Physical appearance on Facebook and Instagram posts is a great concern, it is now expected to look best all the time. And when a skin problem arises, solutions and treatment are searched through the internet instead of consulting a dermatologist to address skin problems. Unfortunately, the use of products widely available and sold in the internet and unlicensed establishments make the skin problems worse one such product is LS BL Cream containing Ketoconazole and Clobetasol and is well-known to the public to cure all types of skin problems.

Pharmacists are advised not to dispense the product without a written prescription from dermatologists or treating physician. Upon presentation of prescription, patients should undergo counselling on the proper use of the product to avoid serious health risks and worsening of their conditions.

The general public is also advised to avoid using the product without proper consultation from dermatologist. It is a prescription product used for the treatment of fungal and yeasts infections. The product contains a very potent steroid which may result in side effects such as worsening condition, acne, skin infections, skin thinning, changes to the color of skin, allergic reaction, increased weight, rounding of the face, stretch marks, etc. There is a recorded case who experienced side effect on the use of Ketoconazole + Clobetasol cream which eventually resulted to death due to staphylococcal scalded skin syndrome associated with the use of topical steroid.

We strongly urge the public to buy medicines only from an FDA licensed drugstores and avoid buying medicines online.

Also, please be informed that there is a proliferation of Ketoconazole + Clobetasol Propionate (LS BL Cream) 10 g in the market which is not registered to the Food and Drug Administration (FDA). The drug product has not gone through the registration and testing process and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, we cannot guarantee their quality and safety.

Seek medical attention immediately if you experience any side effects and report it to FDA via online reporting through our website: www.fda.gov.ph or email at [email protected]. You may also reach us at telephone number (02) 8809-5596.

Attachment:-> FDA Advisory No. 2019-388