Cardiovascular Risk with Meridia


Uploaded by USFoodandDrugAdmin on 27.04.2010

Transcript:
>> Barnett: FDA IS ALERTING HEALTH CARE PROFESSIONALS THAT
MERIDIA IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF
CARDIOVASCULAR DISEASE BECAUSE THE DRUG INCREASES THEIR RISK OF
HEART ATTACK AND STROKE.
MERIDIA, OR SIBUTRAMINE, IS USED TO MANAGE OBESITY.
>> IN NOVEMBER 2009, AN EARLY COMMUNICATION FROM FDA REPORTED
PRELIMINARY STUDY RESULTS SUGGESTING THAT PATIENTS ON
MERIDIA HAD A GREATER FREQUENCY OF CARDIOVASCULAR EVENTS THAN
THOSE NOT TAKING THE DRUG.
ADDITIONAL DATA FROM THE STUDY HAS SHOWN THAT THE EXCESS RISK
OCCURRED IN PATIENTS WITH A HISTORY OF
CARDIOVASCULAR DISEASE.
>> BASED ON THIS INFORMATION, MERIDIA IS NOW CONTRAINDICATED
IN PATIENTS WITH A HISTORY OF CARDIOVASCULAR DISEASE,
INCLUDING CORONARY ARTERY DISEASE,
STROKE OR TIA, CARDIAC ARRHYTHMIAS,
CONGESTIVE HEART FAILURE, PERIPHERAL ARTERIAL DISEASE, OR
UNCONTROLLED HYPERTENSION.
HEALTH CARE PROFESSIONALS SHOULD REGULARLY MONITOR THE BLOOD
PRESSURE AND HEART RATE OF PATIENTS USING MERIDIA AND
DISCONTINUE THE DRUG IF THERE ARE SUSTAINED INCREASES IN
THESE MEASUREMENTS.
>> THEY SHOULD ALSO DISCONTINUE MERIDIA IN PATIENTS WHO DON'T
LOSE AT LEAST 5% OF THEIR BASELINE BODY WEIGHT WITHIN THE
FIRST THREE TO SIX MONTHS OF TREATMENT, BECAUSE FURTHER
TREATMENT ISN'T LIKELY TO BE EFFECTIVE AND EXPOSES THE
PATIENT TO UNNECESSARY RISK.
PATIENTS USING MERIDIA SHOULD TALK TO THEIR HEALTH CARE
PROFESSIONAL ABOUT WHETHER TO CONTINUE USING THE DRUG.