Every year, dangerous prescription medications harm Americans through severe side effects, complications, and interactions that pharmaceutical companies fail to disclose. When the U.S. Food and Drug Administration (FDA) identifies potential safety concerns with an approved drug, their actions can mean the difference between life and death for patients across the nation.
However, the FDA’s authority is limited when it comes to taking drugs off the market. Here’s what you need to know about how this agency can help eliminate and protect patients from dangerous drugs. If you’ve been harmed by a dangerous drug such as Oxbryta, the experienced attorneys at Shapiro Legal Group, PLLC can help.
The FDA’s Drug Safety Surveillance and Monitoring Process
The FDA maintains a comprehensive network of post-market surveillance programs designed to catch dangerous drug reactions that were not detected during clinical trials. For example, the FDA Adverse Event Reporting System (FAERS) collects and analyzes reports of medication problems from healthcare providers, patients, and manufacturers. Clinical reviewers evaluate these reports to identify potential safety concerns that require action.
Through MedWatch, the FDA’s safety reporting program, both medical professionals and consumers can alert the agency to unexpected side effects, quality issues, and medication errors. This early warning system allows the FDA to detect and investigate potential drug safety problems before they impact more patients. When concerning patterns emerge, the agency conducts thorough reviews to determine whether protective measures are needed.
The FDA’s Authority to Remove Dangerous Drugs from the Market
While the FDA closely monitors drug safety, its power to remove dangerous medications has important limitations. The agency cannot directly recall a drug from the market—it can only recommend that manufacturers initiate a voluntary recall. Companies typically comply with these requests, but dangerous drugs could potentially remain available if a manufacturer refuses to cooperate.
The FDA does classify recalls based on the severity of risk:
- Class 1 Recalls: The drug is likely to cause severe adverse health consequences or death.
- Class 2 Recalls: The drug may cause temporary or medically reversible adverse health effects.
- Class 3 Recalls: The drug is unlikely to cause adverse health reactions but violates FDA labeling or manufacturing regulations.
- Market Withdrawal: This occurs when a manufacturer voluntarily removes products with minor violations or quality issues from the market, usually for a technical reason.
The Legal Impact of FDA Safety Actions on Medication Injury Claims
When the FDA issues safety warnings or requests recalls, these regulatory actions often support medication injury lawsuits filed by patients harmed by dangerous drugs. If the FDA finds that a medication poses unreasonable risks, the evidence can help establish that pharmaceutical companies failed to adequately warn doctors and patients about known dangers. Patients who suffer severe side effects, complications, or injuries may be eligible to seek compensation through individual lawsuits or mass tort litigation against drug manufacturers.
Were You Affected by a Dangerous Drug? Get Legal Help Today
If you or a loved one experienced serious complications or injuries after taking a prescription medication, Shapiro Legal Group, PLLC can help you take action. For years, we have fought to hold drug companies accountable when their products harm innocent patients—our dangerous drug lawsuit attorneys know what it takes to recover the compensation that you deserve. Contact us today at (800) 220-0984 for a free consultation to discuss your case and learn about your legal options.