|
Monday, September 15, 2003
Sison: Safety of PPA-laden medicine
By Mark Allen Sison
THE committee on health under Rep. Antonio Yapha Jr. (3rd District, Cebu) is looking into the possible risk to human health posed by phenylpropanolamine or PPA. This is an ingredient used in many prescriptive and over-the-counter (OTC) cough and colds medications and weight control drug products.
The alleged ill effects of PPA were the subject of a privileged speech of Rep. Gilbert Remulla (2nd District, Cavite) last February 4. Rep. Remulla also filed House Resolution 1030 (now referred to as Resolution 605) urging the committee on health to conduct an inquiry into the matter.
In his speech, Rep. Remulla cited a study submitted by the Yale University School of Medicine to the United States Food and Drug Administration (US-FDA), which revealed that PPA has a direct link to the occurrence of hemorrhagic stroke.
Dubbed the Hemorrhagic Stroke Project (HSP), the study covered men and women aged 18 to 49 years old who were hospitalized with a subarachnoid hemorrhage (bleeding into a fluid-filled space between the layers of membranes at the base of the brain near the spine) or intra-cerebral hemorrhage (bleeding in the brain tissue, inside the bony skull) and who had no prior history of stroke.
Rep. Remulla further stated that the results of the study caused the US-FDA to pressure many American drug companies into reformulating their medicines to remove PPA as an active ingredient.
The Cavite lawmaker added that other countries such as Brazil, China, Korea, Malaysia, Mexico, Thailand, and Venezuela have made similar moves. However, he lamented that Philippine authorities have been slow to act on the matter.
"To date, drugs containing PPA are still available over the counter and are in fact still advertised in the media," he said.
He further pointed out that PPA is also known as norephedrine, which is listed under the 1988 United Nations (UN) Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
With the inclusion of the substance in the UN list, concerned government agencies should have banned the same, and yet the draft implementing rules and regulations of the Comprehensive Dangerous Drugs Act of 2002 (Republic Act 9165) say nothing of the regulated use of norephedrine or PPA, he said.
During the recent meeting of the Committee, the Cavite lawmaker told the body that according to the National Poison Control and Information Center (NPCIC) of the Philippine General Hospital, at least six Filipinos had died after taking PPA-laden medicines.
However, the Bureau of Food and Drugs (BFAD) said it has found some methodological flaws in the HSP study that raise questions about the validity of the results.
BFAD director Leticia Gutierrez said the stroke cases in the study group were not comparable to the control group as there were more hypertensive subjects and smokers in the former than in the latter.
"We can therefore say that the higher incidence of stroke in the study group could be due to other factors independent of their PPA use," she said.
She also pointed out that the HSP study focused on PPA-laden drugs used for weight reduction, with doses ranging from 75 to 150 milligrams.
"No drug containing these doses is registered and legally marketed in the Philippines," Gutierrez said.
The BFAD director stressed that the PPA content of most cough and cold medicines sold in the country is only 12.5 to 25 milligrams, with only two products containing 50 milligrams per tablet.
On the reported death of six Filipinos after taking PPA-laden medicines, Gutierrez said the NPCIC data did not show a single death due to PPA toxicity.
Likewise, the BFAD Adverse Drug Reaction Unit did not receive any serious report on PPA, she added.
Responding to a question asked by Rep. Remulla, Dr. Hermogenes Jarin of the Philippine Hospital Association (PHA) said pharmacists should inform the buyers of PPA-laden medicines of the dosage needed based on the doctor's prescription.
However, people suffering from coughs and colds normally do not consult a physician because of the additional burden of paying doctor's fees, he said.
Therefore, Jarin added that these people buy drugs, which may contain PPA without a doctor's prescription.
"Most Filipinos buy PPA to relieve them of their nasal decongestion and other similar ailments because it is affordable. It is considered the poor man's medicine," he added.
Rep. Nerissa Corazon Soon-Ruiz (6th District, Cebu), a practicing physician, added that because of financial constraints, some patients do not buy the entire prescription.
Meanwhile, Gutierrez informed the body that BFAD already issued an advisory to allay fears of the public on the safety of PPA.
The advisory states that PPA is safe and effective if taken at the right dose and for the right indication.
The agency also required drug manufacturers to print a warning on the labels and package inserts of all PPA-laden medicines, she added.
The BFAD also issued a circular requiring all pharmaceutical companies to disseminate precaution or warning on drug products containing PPA.
For his part, Romeo Sanga, deputy executive director of the Dangerous Drugs Board (DDB), confirmed that norephedrine is classified as a "controlled precursor and essential chemical" under RA 9165.
Under the law, Sanga continued, a permit is required for the importation or exportation of norephedrine. A permit is also required to export, import, manufacture, or distribute drug preparations containing the substance.
He said that for pharmaceutical drug preparations in tablet or capsule form containing norephedrine, it can only be prescribed by a doctor who has an S-2 license from the Philippine Drug Enforcement Agency (PDEA).
The DDB official also said there is no recorded incident or intelligence report of the use of norephedrine in the manufacture of methamphetamine or amphetamine in the Philippines.
"It is our opinion that adequate legal and administrative control measures are imposed on norephedrine and that these measures provide for sufficient safeguards to prevent diversion of norephedrine for illicit use in the manufacture of dangerous drugs," he concluded.
As the committee terminated its inquiry into the matter, it adopted the recommendations of the resource persons that correct and proper dissemination of information on PPA-laden medicines be done instead of removing these from the market.
Rep. Remulla expressed his appreciation for the inputs given by the resource persons. He said his end goal is not to control or ban the use of PPA but to protect the people especially the less privileged ones.
"What is important is that they are given the right information on the proper use of PPA," he stated.
(September 14, 2003 issue)
Write letter to the editor. Click here.
Join the Sun.Star message board. Click here. |
|
[ return
to top ]
[ home
]
|
LOCAL NEWS
BUSINESS
OPINION
SPORTS
LIFESTYLE
FEATURE
|
