Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 8, S. 2005)
The Bureau of Food and Drugs (BFAD) is the regulatory body that issued the circular on Selective COX-2 Inhibitors.
The Selective COX-2 inhibitors currently registered include Celecoxib, Parecoxib, Valdecoxib, and Etoricoxib.
There is an increased risk of cardiovascular events associated with COX-2 inhibitors, especially in patients with a history of heart attack, stroke, or those who have undergone angioplasty or cardiac bypass graft surgery.
COX-2 inhibitors are absolutely contraindicated in patients who have had a stroke, heart attack, undergone angioplasty or cardiac bypass graft (CABG), and those with uncontrolled high blood pressure.
Product inserts must include a black box warning on cardiovascular risk for celecoxib, etoricoxib, parecoxib, and valdecoxib, and warnings regarding potential class effects for all NSAIDs, including OTC drugs like ibuprofen.
Doctors and prescribers are advised to use the lowest effective dose of COX-2 inhibitors for the shortest necessary period.
Doctors must consider the balance between gastrointestinal and cardiovascular risks, especially for patients with heart disease risk factors like hypertension, hyperlipidemia, diabetes, smoking, and peripheral arterial disease.
Such patients should immediately consult their doctor to discuss stopping treatment and exploring alternative therapies.
The BFAD ordered the withdrawal of the indication for the management of arthritis with valdecoxib due to its association with increased cardiovascular risks in cardiac bypass graft patients.
Manufacturers are required to submit further safety data from completed or ongoing studies to determine the extent of cardiovascular risks, whether as a class effect or specific to certain compounds.