PPA content to be reduced in medication
PPA content to be reduced in medication
JAKARTA (JP): The Food and Drug Control Agency (BPOM) has set
an April 8 deadline for the pharmaceutical industries to lower
the content of phenylpropanolamine (PPA), a popular substance
used as a decongestant in flu and cough medicines, to a maximum
of 15 milligrams per tablet or tablespoon.
Many popular cold cure tablets sold over the counter currently
contain 25 milligrams of PPA Hydrochloride.
Agency chairman Sampurno told journalists after a hearing with
House of Representatives' Commission VII on Population and
Welfare Affairs that it would also ban advertisements for those
products if the content had not been reduced after April 8.
The Agency's Director of Drugs and Medical Equipment Control
Lucky S. Slamet, the deadline on the reduction of PPA was reached
following an agreement between the Agency and National Commission
of Medicine Assessment (Komnas POJ) in December.
They agreed that the content should be reduced in four months.
Prolonged use or an overdose of PPA can cause hemorrhagic
stroke, high blood pressure and interact adversely with other
medication.
The substance can worsen the condition of patients with
diabetes, glaucoma or those with kidney or liver problems.
He also said that although there has not been a case in
Indonesia, warnings on PPA were first raised when the United
States Food and Drug Administration highlighted the dangers of
the substance.
PPA in the United States is also widely used in diet pills to
help suppress appetite.
Sampurno however here on Monday maintained that consuming the
substance in a proper dosage will avoid negative side effects.
"Fortunately in Indonesia PPA is only used as a nasal
decongestant and cough suppressant and never used to control
appetite," he added.
There are 189 brands of flu and cough medicines containing PPA
produced by 79 pharmaceutical firms in the country.
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 aged between six and 12 years, Sampurno said.
"Medicines containing PPA are not recommended for children
under six and pregnant women, except by doctor's advice,"
Sampurno asserted.
During the hearing on Monday Sampurno also warned the public
on the existence of fake medicines recently found in a drugstore
in Mataram, West Nusa Tenggara.
The medicines found were dextracort, dextamin, supertetra in
capsules, tetracycline in capsules and chloramphenicol.
"The producers are now on trial," Sampurno claimed without
elaborating.(hdn)