New warning out on drugs with PPA

Amid the controversy over the safety risks of phenylpropanolamine (PPA), the Bureau of Food and Drugs (BFAD) has released a warning on the taking of cough and cold drugs containing this chemical substance.

In its advisory dated Feb. 20, the BFAD reiterated that people who have heart disease and uncontrolled or untreated high blood pressure should first consult their doctors before taking drugs containing PPA.

The BFAD said people should be careful in taking drugs with this substance, particularly when they have high blood pressure, toxic goiter, benign prostatic hypertrophy, heart rate irregularity or glaucoma, or are taking anti-depressants.

"PPA is safe and effective if taken in the right dose and for the right indication, that is for nasal stuffiness due to common colds, allergic rhinitis and sinusitis," it said.

According to the PPA, the maximum doses are the following: 6.25 mg every six hours for children aged two to six; 12.5 mg every six hours for those aged seven to 12; and 25 mg every six hours for adults.

The PPA became controversial when Cavite Rep. Gilbert Remulla questioned the manufacture and sale of PPA-containing drugs, mostly cough and cold medication, despite the fact that the substance was a regulated drug under the Dangerous Drugs Act of 2002.

During the time of former BFAD chief Dr. William Torres and former Health Secretary Alberto Romualdez, the bureau issued an administrative order allowing the over-the-counter (OTC) selling of drugs with PPA but set dosage limits.

Under this order, drugs containing PPA lower than 12 milligrams were allowed for OTC sale, drugs with PPA from 12 mg to 50 mg were allowed for sale with prescription from doctors, while drugs containing 50 mg or more of PPA were not allowed for sale.

Pharmacologists had questioned the administrative order, arguing that people can easily go around the regulatory restriction by simply buying several bottles or tablets of drugs with less than 12 mg of PPA.

Some people abuse PPA-containing drugs as a diet aid since they can work as an appetite suppressant, they said.

The United States Food and Drug Administration (FDA) has banned PPA because of findings by Yale University researchers that it induces hemorrhagic stroke in some people, particularly those who have heart condition.

Before its ban, PPA was reportedly widely abused by figure-conscious Americans.

Locally, health officials said such an abuse of PPA as a diet aid was not widely known and practiced.

Health Secretary Manuel Dayrit and BFAD chief Leticia Barbara Gutierrez, both heart specialists belonging to the Philippine Heart Association, vouched for the safety and efficacy of PPA as a nasal decongestant when taken in the right dose and for the right indication.