Title
Mandatory PPA Drug Warning Disclosure
Law
Bfad Bureau Circular No. 03-a
Decision Date
Mar 17, 2003
Drug manufacturers and distributors must provide patient information leaflets detailing precautions and warnings for products containing phenylpropanolamine (PPA), ensuring consumers are informed of safe usage and potential health risks.
drug products
patient information
drug manufacturers
A

Q&A (BFAD BUREAU CIRCULAR NO. 03-A)

The circular mandates the dissemination of information regarding precautions and warnings for drug products containing Phenylpropanolamine (PPA).

All drug manufacturers, traders, importers, and distributors of products containing PPA are required to provide this information.

PPA is indicated for nasal stuffiness due to common colds, allergic rhinitis, and sinusitis.

For children 2-6 years of age, the maximum dose is 6.25 mg every 6 hours.

For adults, the maximum dose is 25 mg every 6 hours.

The health conditions are: high blood pressure, toxic goiter, benign prostatic hypertrophy, heart rate irregularity, glaucoma, and if the person is taking antidepressants.

A person should consult a doctor if they have heart disease or uncontrolled/untreated high blood pressure.

They must provide the patient information leaflet or the BFAD Advisory No. 2003-002 regarding PPA precautions and warnings.

They must provide all drugstores and outlets with the BFAD Advisory No. 2003-002.

The order took effect immediately upon adoption on March 17, 2003.


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