When drugs are determined to pose health risks to patients a recall is initiated. Drugs must be safe in the United States in order to be sold. Manufacturers are allowed, however, to try to correct the issue, which led to the recall. However, if they cannot fix the issue the drug will remain off the market, and they will be under greater scrutiny even if it does go back on the market. Patients also are required to return their prescriptions to their doctors or their pharmacy.
FDA Regulations
When a drug receives approval from the FDA, regulations are put in place in order to see how the drug interacts with patients once on the market. The scope of patients that receive the drug once on the market is much larger than any testing scope could be, so issues can easily still arise. Patients are thereby informed about interactions, health risks and potential side effects. As problems arise, FDA maintains a record of these problems via its online reporting system, while manufacturers themselves review problems as they are received.
Health Risks to Public
If health risks are deemed to danger the public the manufacturers most often simply recal an unsafe drug voluntarily. Usually further study occurs between the administration of a drug and potential health issues. For example, some health risks include a greater occurrence of kidney failure , stroke or heart attack as a result of taking a particular drug.
Market Withdrawal vs. Recall
Recalls are temporary removals of a drug from the marketplace in order to fix issues found to pose a danger. Market withdrawals, on the other hand, are total cessations of production and distribution. Lawsuits, failing sales and other reasons are the result for a market withdrawal.
Conclusion
Drugs are recalled when they pose health risks. Not only does this benefit the people taking the drugs, but it benefits the manufacturers as well who can thereby limit their exposure to legal action as a result of the harm of their products.
