Nationwide Drug Recalls Widely Unreported: Study

A recent study has revealed that numerous drug recalls across the country often escape the notice of both physicians and their patients, with the U.S. Food & Drug Administration (FDA) failing to adequately alert the public about the severe and sometimes deadly risks associated with some commonly used drugs. The study points to shortcomings in the FDA’s system for notifying the public about ‘Class I’ drug recalls, a category denoting the most critical level where the use of the drug could result in serious harm or death. FDA representatives have acknowledged these issues and are actively working towards bettering their notification processes for drug recalls.

Free Drug Recall Lawsuit Evaluation: If you or a loved one has been injured by a drug that has been recalled, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the drug and we can help.

What’s the problem?

For the study, which was published in the Archives of Internal Medicine, researchers investigated 1,700 drug recalls issued between 2004 and 2011. They found about one major recall per month, and determined that 91 of those were Class I recalls, but not all were reported.

Of the 91 Class I recalls, the Recall Alert System only issued notices for 55 of them. The MedWatch reporting system did slightly better, issuing notices for 18 of the remaining Class I recalls. That leaves another 18 – approximately 20% – that were not reported by any FDA system.

The researchers went on to state that not only is incompleteness of reporting a huge problem, but that doctors may have difficulty determining which recalls are important and which are not, due to the fact that both systems attempt to report every drug recall. For example, veterinary drug recalls are reported in exactly the same manner as Class I drugs, which may be life-threatening for humans.

“Equally problematic, the Class I recalls that are communicated through the Recall Alert System become buried in a system that is also used for recalls that have little or no bearing on patient care,” the researchers determined. “It may be difficult for providers who subscribe to and rely on these alerting systems to identify those recalls that are of particular importance.”

After assessing the results of their study, the researchers proposed a comprehensive new strategy for ensuring that healthcare providers are promptly notified when there are clinically important nationwide drug recalls.

Related Article: Drug Recall (Lawyers & Additional Information)

See the other dangerous drugs lawsuits which we’ve covered.

FAQs

1. What Actions Can Be Taken if a Drug Recall Is Not Reported?

If a drug recall is not reported, consumers can file complaints with the FDA, seek legal recourse, and advocate for stricter enforcement of reporting regulations.

2. How Do Unreported Drug Recalls Affect Public Trust in Pharmaceutical Companies?

Unreported drug recalls severely damage public trust in pharmaceutical companies, leading to increased skepticism, reduced confidence in drug safety, and potential legal and financial repercussions for the manufacturers.

3. What Legal Responsibilities Do Manufacturers Have Regarding Drug Recall Notifications?

Manufacturers are legally required to promptly notify the FDA and the public of any drug recalls, ensuring consumer safety and compliance with federal regulations to prevent harm.

Do I Have a Drug Recall Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in drug recall lawsuits. We are handling individual litigation nationwide and currently accepting new drug-induced injury cases in all 50 states.

Free Drug Recall Lawsuit Evaluation: If you or a loved one has been injured by a drug that has been recalled, you should contact our law firm immediately. You may be entitled to compensation by filing a drug recall suit and we can help.