QuestionsQuestions (BFAD BUREAU CIRCULAR NO. 11, S. 2005)
It is a BFAD Bureau Circular (an administrative issuance). It primarily requires manufacturers to revise the labels/package inserts of marketed selective COX-2 inhibitors (e.g., Celebrex, Arcoxia) and prescription/OTC NSAIDs to include specific boxed warnings, contraindications, caution statements, and patient/consumer information materials.
It implies that the earlier PSD memos were not yet to be implemented at that time; manufacturers were instead directed to revise labels under the circular’s requirements, following the deferred implementation of those PSD memos.
It should be placed on the first page of the insert, right after the posology/dosing statements (and the annexes further advise placing right after “Dosage and Administrator,” preferably on the first page).
Selective COX-2 inhibitors (e.g., celecoxib, etoricoxib) and NSAIDs (both prescription and over-the-counter non-prescription NSAIDs), with specific instructions per category.
Potential cardiovascular (CV) events and serious, potentially life-threatening gastrointestinal (GI) bleeding, along with category-specific contraindications and caution statements detailed in the annexes.
Aspirin is exempted because it is a platelet inhibitor and, in clinical studies, has been shown to reduce risk of cardiovascular events. Paracetamol is not included because it is used as an antipyretic and analgesic for mild to moderate pain.
Not to be given to patients with history of stroke (CVA), heart attack (MI), CABG, and congestive heart failure (CHF) NYHA II–IV.
Examples include: not to be given to patients with allergy to NSAIDs and those with asthma; exercise caution in ischemic heart disease and risk-factor patients (e.g., hypertension, hyperlipidemia, diabetes, smoking, peripheral arterial disease); use lowest effective dose for shortest duration; stop intake with skin rash/signs of hypersensitivity; include potential GI (gastric and liver) and renal toxicities if not already instituted.
Not to be given to those with history of stroke (CVA), heart attack (MI), CABG, uncontrolled hypertension, and CHF NYHA II–IV.
Contraindication in patients with history of hypersensitivity to ASA or any other NSAID; NSAIDs are contraindicated in patients with previous or active peptic ulceration; and prescription NSAIDs include contraindications for use in CABG operations.
Use with caution; implement dose adjustment using the lowest effective dose and monitoring renal and liver functions.
Contraindications for use in Coronary Artery Bypass Graft (CABG) operations.
It states available data do not suggest increased risk of serious CV events for short-term and low dosage use. OTC NSAIDs are allowed in the market provided package insert revisions are instituted with more specific CV/GI risk info and stronger warnings on limiting dose/duration.
More specific info about potential CV and GI risks; stronger warnings limiting dose and duration per package instructions; warning about potential skin reactions and to stop treatment once itchiness or rashes occur; and public information via posters in drugstores.
Posters and leaflets (English and Tagalog poster content is illustrated in Annex C) must be made available in drug outlets, including key safety information and instructions on when to stop taking the medicine and consult a doctor.
GI: burning stomach pain, black bowel movements, or bloody coffee-ground vomiting; Liver: nausea, vomiting, tiredness, loss of appetite, jaundice, “flu-like symptoms,” dark urine; Kidney: worsening of kidney problem; Swelling/fluid retention: fluid retention and potentially serious issues especially with high BP or heart failure.
Consult doctor if allergic to aspirin; it lists consultations for heart problems, high blood pressure, stomach ulcers/bleeding, asthma, allergy to aspirin/NSAID, renal problem, and if pregnant/trying to be pregnant/breastfeeding.