High dosage drugs still widely available: Sampurno<\/p>\n
JAKARTA (JP): Flu and cough medicines containing more than 15
\nmilligrams of phenylpropanolamine (PPA) are still widely
\navailable despite the government's May 8 deadline for withdrawal
\nof the products.<\/p>\n
Food and Drug Control Agency (BPOM) head Sampurno said that
\nthe government had given pharmaceutical companies since December
\nto withdraw their old products from the market and replace them
\nwith products containing a reduced PPA content, which should not
\nexceed 15 milligrams per dosage.<\/p>\n
According to Sampurno, most drug producers have obeyed the
\ngovernment regulation. He praised the companies for their quick
\nresponse in adhering to government policy.<\/p>\n
He said that, out of the 65 products which had been withdrawn
\nfrom the market, 48 of them had been reformulated, while 17 are
\nno longer produced.<\/p>\n
Sampurno admitted that it was difficult to control sales at
\nunlicensed drug stores, such as kiosks.<\/p>\n
\"We're aware that some medicines containing more than the
\napproved PPA content are still available in many small shops.
\nHowever, efforts to withdraw them from the market are still
\ncontinuing,\" Sampurno told The Jakarta Post by telephone on
\nTuesday.<\/p>\n
In December, the agency warned drug producers to strictly
\nabide by the new rule and threatened severe sanctions to those
\nwhich did not.<\/p>\n
The companies are not only obliged to reformulate with a
\nreduced PPA content, but to also print a warning on the
\nmedicines' packaging and brochures, alerting customers to the
\ndangers of the substance.<\/p>\n
The government had warned that lengthy use or an overdose of
\nPPA could cause hemorrhagic stroke and high blood pressure.<\/p>\n
There are 189 brands of flu and cough medicines containing PPA
\nproduced by 79 pharmaceutical firms in the country.<\/p>\n
According to data released in December by the Foundation to
\nEmpower Indonesian Health Consumers (YPKKI), no less than 76
\nover-the-counter brands had a PPA content higher than 15
\nmilligrams.<\/p>\n
They include the popular Neozep, Mixagrip, Procold, Stop Cold,
\nBodrex, Contrex, Ultraflu and Flugan.<\/p>\n
The use of PPA is considered safe if it does not exceed 75
\nmilligrams per day for adults and 37.5 milligrams per day for
\nchildren between six and 12 years of age, Sampurno said.<\/p>\n
PPA is an active substance commonly used as a decongestant
\nand, until recently, many popular medicines sold over the counter
\ncontained 25 milligrams of PPA.<\/p>\n
In countries such as the United States, PPA is also widely
\nused in diet pills to help suppress appetite.<\/p>\n
Sampurno said that the effects of PPA in the decongestants are
\nnot really lethal but, as the government had made an
\ninternational commitment, the agency was required to supervise
\nusage of the substance.<\/p>\n
Separately, Uung Sendana, sales manager of pharmaceutical
\ncompany PT Dankos Laboratories, the producer of Mixagrip, said
\nthat since January the company and its distributors had been
\nrecalling their products and replacing them with new products
\ncontaining a lower PPA content.<\/p>\n
\"However, how can we recall our products from small kiosks
\nwhich are not aware of the government warning?\" Uung told the
\nPost on Tuesday.<\/p>\n
A PT Medifarma Laboratories Inc. employee said that their
\nproduct Decolgen only contains 12.5 milligrams of PPA, but was
\nrecalled because there was no warning box on the package.<\/p>\n
YPKKI chairman Marius Widjajarta has a different view.<\/p>\n
Marius alleged that many companies are only repackaging their
\nproduct, while continuing to sell the previous medication with a
\nhigh PPA content.<\/p>\n
He said it was difficult to check the actual PPA content of
\neach drug.<\/p>\n
According to him, only Sampurno's office and the producers
\nhave suitable equipment for checking the content.<\/p>\n
\"I suspect the possibility of repackaging from flu and cough
\nmedicine producers where PPA content is more than 15 percent,\"
\nMarius said. (bby)<\/p>",
"url": "https:\/\/jawawa.id\/newsitem\/high-dosage-drugs-still-widely-available-sampurno-1447893297",
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