Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 11, S. 2005)
The main directive is to revise the labels (package inserts) of all marketed selective COX-2 inhibitor drugs and prescription and OTC NSAIDs to include boxed warnings on cardiovascular and gastrointestinal risks, with specific instructions for manufacturers, practitioners, and patients.
Aspirin (ASA) and Paracetamol are exempted. Aspirin is a platelet inhibitor shown to reduce cardiovascular risk, and Paracetamol is used for mild to moderate pain as an antipyretic and analgesic.
They must include black boxed warnings on cardiovascular and gastrointestinal risks, contraindications for certain patients, instructions to use the lowest effective dose for the shortest duration, commitment to conduct long-term safety studies, and mandatory patient leaflet information.
Absolute contraindications include patients with a history of stroke (CVA), heart attack (MI), coronary artery bypass graft (CABG), and congestive heart failure (CHF) NYHA class II-IV.
Warnings about allergies to NSAIDs, asthma, use caution in patients with ischemic heart disease or risk factors (hypertension, hyperlipidemia, diabetes, smoking, peripheral arterial disease), and instructions to stop the drug if rash or hypersensitivity signs appear.
They must include black box warnings about cardiovascular and serious gastrointestinal events, contraindications in CABG operations, and instructions for patients to discuss risks and benefits with their doctors while using the lowest effective dose for the shortest duration.
OTC NSAIDs must have specific information about cardiovascular and gastrointestinal risks, stronger warnings to limit dose and duration as per instructions, warnings about potential skin reactions, and instructions to stop use if rashes or itchiness occur.
Posters and leaflets with information about NSAIDs' risks and usage instructions must be made available and displayed in drugstores and drug outlets.
While this circular does not specify penalties, non-compliance with BFAD directives can lead to sanctions such as product recalls, suspension of licenses, and administrative or legal actions under Philippine food and drug laws.
Aspirin is classified differently because it acts primarily as a platelet inhibitor and has been clinically shown to reduce the risk of cardiovascular events, unlike other NSAIDs that have associated cardiovascular risks.