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ike many Indonesians, Syauqi Stya Lacksana, 21, and his family have for years used over-the-counter drugs to treat mild illnesses and infections, including oral ulceration.

However, Syauqi was shocked when the Food and Drug Monitoring Agency (BPOM) announced in a statement on Friday that a topical antiseptic often used to treat sprue needed to be recalled from the market because it contained a dangerous substance.

Marketed under the brand name Albothyl, the policresulen concentrate can be bought in any drug store without a doctor’s prescription. It is also commonly used as an antiseptic to treat leukorrhea. The BPOM announcement angered Syauqi, who had long used Albothyl to treat sprue as it took him days to heal using other medicine.

To treat oral ulceration, Syauqi said, he only needed to drop the solution directly onto sores in his mouth. “There will be a little burning sensation for a while, but it doesn’t really hurt,” he told The Jakarta Post on Friday.

“We have always had it at home. My aunts and uncles use it too,” said Syauqi, a translator who lives in Bekasi, West Java.

Syauqi said the BPOM announcement annoyed him and his family. “If it is really medically dangerous, why didn’t the BPOM tell us at the very beginning? Why was it just announced?” he said. Having been distributed in Indonesia for 35 years by Pharos Indonesia, a pharmaceutical company that has produced medicine and health supplements for 45 years, Albothyl might have caused health problems to consumers.

Responding to such a concern, the BPOM deputy head for the monitoring of therapeutic products and narcotics, psychotropics and addictive substances, Nurma Hidayati, said the agency received public complaints about the side effects of Albothyl only recently, even though the product had been in the market for more than three decades.

Nurma said that, over the past two years, the BPOM had received 38 reports from consumers who complained about serious side effects after using the antiseptic solution. Some consumers said their sprue was enlarged, opened and infected.

Based on the reports, the BPOM, together with pharmacologists from universities and clinicians from professional associations, conducted an assessment on the safety of the Albothyl concentrate.

Nurma said that, based on the assessment, the BPOM identified policresulen, which comprises 36 percent of the concentrate, as potentially harmful and no longer recommended its use in hemostatic or antiseptic treatment, both during surgery and for dermatology use.

“The risk is higher than the benefit, so we have to revoke the circulation permit [of policresulen],” said Nurma.

The BPOM has given Pharos Indonesia one month to recall all Albothyl products from the market. The move is expected to be followed by a recall of other products containing policresulen, namely Medisio (Pharos Indonesia), Prescotide (Novel Pharmaceutical Laboratories) and Aptil (Pratapa Nirmala).

Indonesian Dentists Association (PDGI) deputy chairman Hananto Seno said policresulen worked by producing a slight chemical burn to the wounded area in a process that could kill bacteria, helping to treat sprue.

“However, if used carelessly, the policresulen solution can spread to and destroy healthy tissue,” he said.

If Pharos Indonesia is to keep Albothyl in the market, the level of policresulen used in the product must be reduced.

Pharos Indonesia said in a press statement received by the Post on Friday that the company had always implemented good manufacturing practices in all stages of product manufacturing, from testing to distribution.

“We respect the BPOM decision to freeze our permit license and will obey the agency’s decision until there is approval for us to make improvements. We will also [...] recall all products [containing policresulen] from the market,” Pharos Indonesia spokesperson Ida Nurtika said.

“The recall process will be carried out as soon as possible across Indonesia.”

Only a week ago, Pharos Indonesia recalled and destroyed a different product, the Viostin DS food supplement, after the BPOM found it contained pork derivatives.