Mandatory PPA Drug Warning Disclosure

Ask AI

BFAD BUREAU CIRCULAR NO. 03-A: Mandatory PPA Drug Warning Disclosure

Getting related questions...
What do you want to know about the law?
Your conversations and searches stay on your device. We do not store or track your activity on our servers. To know more about our privacy commitment see jur.ph/privacy Ask AI provides quick answers grounded in full case texts to avoid mistakes. Always verify with the original text.

Ask AI

Title Supreme Court: 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.

patient information

drug manufacturers

A

Mandatory Dissemination of Information

Required to provide patient information leaflets that contain the precaution and warning related to PPA.
If leaflets are not yet printed, the BFAD Advisory No. 2003-002 must be provided instead.
Drugstores and outlets are mandated to give the leaflet or advisory to every customer purchasing PPA-containing products.

Safety and Efficacy of PPA

PPA is safe and effective if:
- Taken at the right dose.
- Taken for the right indication: nasal congestion due to common colds, allergic rhinitis, and sinusitis.

Recommended Maximum Dosage

For children:
- Ages 2-6 years: 6.25 mg every 6 hours.
- Ages 7-12 years: 12.5 mg every 6 hours.
For adults: 25 mg every 6 hours.

Health Conditions Requiring Caution

Avoid or be careful if the patient has:
1. High blood pressure
2. Toxic goiter
3. Benign prostatic hypertrophy
4. Heart rate irregularity
5. Glaucoma
6. Is taking antidepressants

Conditions Warranting Consultation with a Doctor

Patients suspecting the following conditions should consult a physician before using PPA:
1. Heart disease
2. Uncontrolled or untreated high blood pressure

Effective Date and Authority

Immediately effective as of March 17, 2003.
Issued by Director Leticia Barbara B. Gutierrez, M.S., Bureau of Food and Drug Administration (BFAD).

END