Chantix Belongs To The Group Of Medicines That Require REMS
Date: 14th February 2013
A government report discloses that medications such as varenicline (Chantix) and oxycodone (Oxycontin) require risk evaluation and mitigation strategies (REMS). These medicines are related to enhanced risk for myocardial infarction, suicidal tendencies and drug addiction. However, according to the report, the program initiated by the Food and Drugs Administration (FDA) for supervising drug safety risks is ineffective. This is due to the fact that pharma companies are not able to fulfil the requirements of the program and agencies are not capable of enforcing it.
If a medicine made by a particular pharma company shows risks that surpass its benefits, then the drug manufacturer need to submit risk evaluation and mitigation strategies (REMS) to the FDA. The manufacturers have a timetable for submitting appraisals relating to the functioning of the REMS. If the appraisals are uncompleted or not provided in time, then it becomes difficult for the FDA to secure public safety with regard to those medicines.
The report highlights that last year, the FDA re-examined 49 REMS and out of that, only seven were able to satisfy the goals. It also states that the results heighten concerns relating to the efficacy of the REMS program.
The report was revealed by the Inspector General for the Department of Health and Human Services.