PPA IN OVER-THE-COUNTER DRUGS SAFE -- BFAD

Manila, Jan. 25, 2003 - The Bureau of Food and Drugs (BFAD) said yesterday that medical products containing phenylpropanolamine (PPA) are safe.

In a memorandum to Dr. Edwin Bolastig, executive assistant of Health Secretary Manuel Dayrit, BFAD director Leticia Gutierrez said that BFAD is allowing the sale of products containing PPA but has guidelines for this.

BFAD guidelines provide that products with 25 mg or below of PPA can be sold over the counter; those with 25 to 50 mg shall be classified as prescription drugs; while products with more than 50 mg shall no longer be "registerable."

BFAD operations manager Irene Gonzales said that PPA can only induce hemorrhagic stroke when a person takes in a dose of 100 mg or more.

Gonzales added that the guidelines on products containing PPA are stated in Administrative Order 163 issued on Dec. 4, 2000 during the time of then Health Secretary Alberto Romualdez, when questions on the safety of PPA were previously raised.

Earlier, Rep. Gilbert Remulla (LDP, Cavite) said the United States Food and Drugs Administration (FDA) declared PPA as unsafe for human consumption in November 2001 after a study by Yale University researchers concluded it can induce stroke and brain problems.

In a related development, the House oversight committee on illegal drugs decided yesterday to look into the continued use of the banned substance PPA in the manufacture of drugs.

Remulla, who sits in the committee, told reporters yesterday that the panel has summoned several concerned government officials to its initial inquiry set for Wednesday next week.

He said those invited include Dayrit and the heads of BFAD and the Dangerous Drugs Board.

"We will ask them why they have failed to enforce Republic Act 9165, known as the Dangerous Drugs Act of 2002, which bans PPA because it has been found to cause stroke," he said

Remulla pointed out that the law was enacted in July last year and that the agencies tasked to implement it should have by now prescribed its implementing rules.

"There should be no inaction, quibbling and dilly-dallying on this matter because it involves the health of our people," he stressed.

On Thursday, after receiving verified reports that drugs containing PPA are still being sold, Remulla warned the public about the danger of using them.

Yale researchers blamed up to 500 annual deaths in the US on the use of PPA-laden preparations.

Here, Remulla said the banned substance is being used in cold, cough, fever, and nasal decongestant medicines.

Yesterday, some Department of Health officials, in radio interviews, contradicted the findings of American researchers.

Reacting to these officials' contrary views, Remulla said Yale University's scientific findings are more credible than the views of some "swivel-chair bureaucrats."

"US researchers have long ago found nicotine to be addictive and harmful to human health. In fact, American courts have awarded billions in dollars in damages to victims. Here, we continue to take those findings for granted despite the obvious great risk to our people," he said. (Star)