FDA warns against acne treatment and contraceptive drug sold online

PHOTO from fda.gov.ph

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against availing of medicines sold online, saying that no registered pharmacy or drugstore in the country is peddling drug products through the Internet.

The FDA issued this reminder after it found a steroidal anti-androgen and birth control drug product being sold online without the necessary permits from the agency.

In an advisory, the agency said the use of cyproterone acetate+ethinylestradiol (OC-35) 2 mg/0.035mg tablet may cause potential danger or injury to consumers as it did not undergo the necessary product, evaluation, registration and testing by the government.

The unregistered product, OC-35, is being manufactured in Munster, Germany, by Haupt Pharma Munster GmbH. It is used for acne treatment, pregnancy prevention and birth control.

The component, cyproterone acetate (CPA) is used for treatment of prostate cancer and androgen-related dermatological conditions such as acne and seborrhea, among others.

According to data, while CPA is widely used in Europe, Canada and Mexico, the United States FDA did not approve this drug due to concerns about chemical-driven liver damage.

“In the interest of protecting public health and safety and pursuant to Section 12 of the Food and Drug Administration Act of 2009, the field regulatory operations officers are hereby ordered to seize the aforementioned unregistered drug product found in the market,” ordered the FDA.

The agency also warned establishments and outlets across the country against selling or dispensing the medicine or they shall face penalties.

It urged local government units and law enforcement agencies to make sure that the undocumented drug product will not be sold or offered for sale in their respective areas of jurisdiction.

“It is hereby reiterated that at present, there is no FDA-licensed pharmacy that is selling medicines online,” added the FDA.

It advised consumers to purchase their medication only from FDA-licensed establishments, where products have undergone evaluation and testing to ensure their quality, safety and efficacy.

“Please look for the FDA registration number on the product label. Moreover, please be reminded that drug products registered with FDA Philippines bear in their labels information in English and/or in Filipino for all consumers to understand,” it added.