High dosage drugs still widely available: Sampurno

JAKARTA (JP): Flu and cough medicines containing more than 15 milligrams of phenylpropanolamine (PPA) are still widely available despite the government's May 8 deadline for withdrawal of the products.

Food and Drug Control Agency (BPOM) head Sampurno said that the government had given pharmaceutical companies since December to withdraw their old products from the market and replace them with products containing a reduced PPA content, which should not exceed 15 milligrams per dosage.

According to Sampurno, most drug producers have obeyed the government regulation. He praised the companies for their quick response in adhering to government policy.

He said that, out of the 65 products which had been withdrawn from the market, 48 of them had been reformulated, while 17 are no longer produced.

Sampurno admitted that it was difficult to control sales at unlicensed drug stores, such as kiosks.

"We're aware that some medicines containing more than the approved PPA content are still available in many small shops. However, efforts to withdraw them from the market are still continuing," Sampurno told The Jakarta Post by telephone on Tuesday.

In December, the agency warned drug producers to strictly abide by the new rule and threatened severe sanctions to those which did not.

The companies are not only obliged to reformulate with a reduced PPA content, but to also print a warning on the medicines' packaging and brochures, alerting customers to the dangers of the substance.

The government had warned that lengthy use or an overdose of PPA could cause hemorrhagic stroke and high blood pressure.

There are 189 brands of flu and cough medicines containing PPA produced by 79 pharmaceutical firms in the country.

According to data released in December by the Foundation to Empower Indonesian Health Consumers (YPKKI), no less than 76 over-the-counter brands had a PPA content higher than 15 milligrams.

They include the popular Neozep, Mixagrip, Procold, Stop Cold, Bodrex, Contrex, Ultraflu and Flugan.

The use of PPA is considered safe if it does not exceed 75 milligrams per day for adults and 37.5 milligrams per day for children between six and 12 years of age, Sampurno said.

PPA is an active substance commonly used as a decongestant and, until recently, many popular medicines sold over the counter contained 25 milligrams of PPA.

In countries such as the United States, PPA is also widely used in diet pills to help suppress appetite.

Sampurno said that the effects of PPA in the decongestants are not really lethal but, as the government had made an international commitment, the agency was required to supervise usage of the substance.

Separately, Uung Sendana, sales manager of pharmaceutical company PT Dankos Laboratories, the producer of Mixagrip, said that since January the company and its distributors had been recalling their products and replacing them with new products containing a lower PPA content.

"However, how can we recall our products from small kiosks which are not aware of the government warning?" Uung told the Post on Tuesday.

A PT Medifarma Laboratories Inc. employee said that their product Decolgen only contains 12.5 milligrams of PPA, but was recalled because there was no warning box on the package.

YPKKI chairman Marius Widjajarta has a different view.

Marius alleged that many companies are only repackaging their product, while continuing to sell the previous medication with a high PPA content.

He said it was difficult to check the actual PPA content of each drug.

According to him, only Sampurno's office and the producers have suitable equipment for checking the content.

"I suspect the possibility of repackaging from flu and cough medicine producers where PPA content is more than 15 percent," Marius said. (bby)