Drugs with PPA put consumers at high risk: YPKKI

JAKARTA (JP): To give four months to cough and cold medicine producers to "adjust" the amount of phenylpropanolamine (PPA) -- a substance reportedly known to cause hemorrhagic stroke -- in their drugs, is a risky disservice to the public, the chief of the Indonesian Consumers Foundation for Health (YPKKI) said.

Marius Widjajarta called on the directorate general for food and drug control on Sunday to withdraw all cough and cold medicines containing over 15 milligrams of PPA, which acts as a decongestant, as soon as possible.

"Either they withdraw these drugs very soon, or they should give producers of cough and cold medicines only one month to adjust the PPA level in their medicines, or they should replace PPA with a safer substance," Marius said, as quoted by Antara.

Earlier, Director General for Food and Drug Control Sampurno gave drug producers four months to adjust the amount of PPA in their drugs, so that an adult should not take more than 60 milligrams, and a child, not more than 30 milligrams in a day.

Marius added on Sunday that in the next four months, drug producers would profit tremendously from the sale of their medicines, currently sold in the market with dangerous PPA levels, before they are officially withdrawn.

"Consumers are put at a high risk. For instance, instructions on the bottle of a cough or cold medicine with more than 25 milligrams of PPA, will state that two spoons of the syrupy medicine should be taken thrice a day... that's 150 milligrams already in one day," Marius said.

As reported earlier, Sampurno said that although there had been no cases of hemorrhagic strokes in Indonesia caused by PPA, careful use of medicines containing the substance were prescribed after the United States Food and Drug Administration (FDA) decided to withdraw medicines which contain PPA, starting this month, due to complaints about side effects.

PPA is an active substance commonly used in flu and cough medicine. It acts as a decongestant.

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

"Proper dosage will avoid side effects. Fortunately, in Indonesia, PPA is only used as a nasal decongestant and cough suppressant and never used to control appetite," Sampurno said.

Research says an overdose of PPA can also cause elevated blood pressure and interact adversely with other medication. The substance can worsen the health of patients with diabetes, glaucoma or those with kidney or liver problems.

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.

"Medicines containing PPA are not recommended for children under six and pregnant women, except under doctor's advice," Sampurno asserted.

Patients who feel a racing heartbeat, nausea or sleeping disorder after taking medication with PPA should stop using it, he added. (ylt)