TO REDUCE potential dosing errors in children under two years old, local pharmacies, including the University of Santo Tomas Hospital (USTH) Pharmacy, are now pulling out Dimetapp oral drops, an infant cold medicine, from the drugstore shelves.
In an open letter, last October 17, Wyeth Philippines Inc, the local manufacturer of Dimetapp oral drops, stated that although many consumers are able to use the drug effectively, children under two years old are most at risk to overdose and accidental ingestion of the medicine.
The letter, signed by Rafael Lim, Wyeth’s sales director, and Edwin Kuizon, Wyeth’s marketing director, also stated several changes in the labeling of dosage in the drug firm’s medicines for children, in coordination with the Bureau of Food and Drugs (BFAD). For children below two years old, parents and doctors will be advised not to use the medication. For children aged two to six years old, along with the given dosage, parents will be advised to consult health professionals first.
According to Emilia Reyes, supervisor of the USTH Pharmacy, the withdrawal is due to Phenylpropanolamine (PPA), a chemical compound found in the medication.
“PPA found in Dimetapp may cause increased blood pressure, tightness of the chest, rapid heart beat, and an increased risk of hemorrhagic stroke,” she said.
Reyes added that in 2001, the United States Food and Drug Administration (FDA) performed steps to remove medicines with PPA from the market.
“The FDA ordered its withdrawal after discovering that it may increase the risk of hemorrhagic stroke. However, they eventually allowed its continued availability in the market provided that people will be prescribed to use it within a certain allowable dosage,” she said.
According to BFAD guidelines, Wyeth will have until December 1 to complete the product withdrawal process. Failure to withdraw the products will lead to court action or product seizure.
The withdrawal of infant cough and cold medicines first occurs in the United States last October when manufacturers of nonprescription infant cough and cold medicines such as Johnson and Johnson, Novartis, and Wyeth pulled out their products from the market due to dangers of overdosage and drug toxicity, which may lead to death or serious injury. Some of the withdrawn products include Robitussin Infant Cough DM Drops, Triaminic Infant & Toddler Thin Strips Decongestant, Tylenol Drops Plus Cold & Cough, and Dimetapp Decongestant Plus Cough Infant Drops.
But according to Aileen Balane, officer-in-charge of the USTH Pharmacy, as of the moment, BFAD has not yet released any instructions on the withdrawal.
“We have not received anything yet from BFAD, although they have stated a few days ago that they will release a statement on the issue. However, Wyeth, in coordination with BFAD, has already sent a letter telling us to withdraw Dimetapp oral drops from the shelves within 30 days,” Balane said. Alena Pias P. Bantolo
