Things You Need to Know about FDA Drug Recalls
Why is there a need for FDA drug recalls and how long can a certain drug be pulled out of the market? The primary reason why FDA recalls certain use of medication is because of the risk posed by using such prescriptions. However, it takes about five years before a certain drug can be revoked from pharmaceutical establishments, which means that probably by that time, there must have been a few numbers of harm or deaths.
The United States Food and Drug Administration is responsible for approving, regulating, as well as recalling the use of certain medications available in the marketplace. In order for these drugs to be approved, pharmaceutical companies provide budget for FDA to conduct clinical trials so that they can gain approval from FDA in such cases where the drug has been tested safe. FDA also regulates the use of certain medications by labeling them. This may also come in safety alerts announcements so that both doctors and citizens are aware of probable risks that come along with taking such medications.
FDA drug recalls is also a responsibility of this agency as part of the Department of Health and Human Services. Drug recall is the most serious safety warning that can be advised by the FDA to pharmaceutical companies. But what really happens during a drug recall? If there are unfavorable risks from taking such prescriptions, FDA will advise the pharmaceutical company to recall drugs. This is important so that pharmacists, hospitals, doctors and the entire health community will stop using the medicine and eliminate the possibility of possible harm or death to any individual. If the company does not heed FDA’s advice, FDA will file an injunction for that particular company.
If the company recalls the drug, FDA will monitor that particular pharmaceutical company for any status regarding their product. The level of a recall depends on the classification set by FDA. Class I recall is for drugs that causes serious health risks and even death. Class II is for drugs with temporary but nonlethal health risk such as incorrect labels of dosage in the prescription. And finally, Class III is for certain medications that do not necessarily have hazardous effect on humans but have problems with the labeling and quality, which mostly stem from not complying with FDA’s standard.
It is important to also be careful in taking prescriptions because although there are FDA drug recalls, they are only done once the risk has already been done.