FDA Launches New Tool to Help Identify Dangerous Drugs

The U.S. Food and Drug Administration (FDA) recently launched a new tool designed to help patients, family members and healthcare providers identify dangerous drugs. The FDA receives approximately six million adverse event reports each year, and its previous system for recording and publishing these reports was both time-consuming and expensive. According to the FDA, its new system will both streamline the process of filing reports and make it easier for members of the public to find critical information about potential complications and other risks. Learn more from an experienced dangerous drug lawyer at Searcy Denney:

The FDA’s New AEMS Reporting System Will Provide Real-Time Reports About Dangerous Drugs

According to the FDA, its new Adverse Event Monitoring System (AEMS) will be able to provide real-time information about reports the agency receives related to dangerous drugs. The FDA describes the AEMS reporting system as a “major modernization,” and it will replace several of the FDA’s older reporting systems. These include the FDA Adverse Event Reporting System (FAERS) and Vaccine Adverse Event Reporting System (VAERS), both of which were focused specifically on exposing the risks associated with potentially dangerous drugs.

Like these outgoing programs, the AEMS reporting system will rely on reports submitted by patients, family members, and healthcare providers. As the FDA writes:

“Although these reports have limitations, they can help identify potential safety signals, such as patterns or clusters of adverse events that might indicate previously unknown risks.”

While a report filed with the FDA is not necessarily indicative of a broader issue (or even an issue at all), patients and family members can use the AEMS reporting system as one source of information when making decisions related to their health and their legal rights. If you or a loved one has taken a drug that has been identified as potentially dangerous, it may be worth seeking a medical opinion to find out whether continuing to take the drug makes sense—or whether you may need to be concerned about potential complications. If your doctor (or your loved one’s doctor) raises concerns, it may be worth talking to a dangerous drug lawyer as well.

What is a “Dangerous Drug?”

All of this raises an important question: What is a “dangerous drug”?

There isn’t a precise definition. Generally speaking, a drug can be considered dangerous if either: (i) it presents risks that are unknown to patients, family members or healthcare providers; or, (ii) its risks outweigh its potential benefits. These issues can arise for various reasons, including (but not limited to):

• Issues with the drug’s formulation
• Issues with the drug’s clinical trials
• Issues with the manufacturing process
• Contamination during shipping or storage
• Inadequate warnings from the drug’s manufacturer

These issues, among others, can all provide grounds for patients and family members to file dangerous drug claims against the manufacturers that are responsible. Product liability laws hold drug manufacturers strictly accountable for ensuring that their drugs are safe for intended use. This means that while patients and families can file claims against drug manufacturers based on negligence, proof of negligence isn’t required.

What Should You Do If You Have Concerns About a Dangerous Drug?

Let’s say you have concerns about a dangerous drug. What should you do? Regardless of whether a drug has been identified as potentially dangerous in the FDA’s new AEMS reporting system, if you have concerns as a patient or family member, you should:

1. Seek a Medical Opinion Promptly

As we said above, it is important to seek a medical opinion anytime you have concerns about your (or a loved one’s) health. It is important not to rely solely on information you find online. Not only could this information be incomplete or inaccurate, but it also may or may not be relevant to your (or your loved one’s) individual circumstances.

2. Take Notes About Why You Have Concerns

Either before or after you see a doctor, you should take notes about why you have concerns. What made you start to look for information online? When did you start to have concerns, and how have your concerns grown or evolved over time? If you found information in the FDA’s AEMS reporting system, what did you find, and does it align with what you or your loved one has experienced?

3. Make Informed Decisions About Your (or Your Loved One’s) Care

After seeing a doctor, you should make informed decisions about your (or your loved one’s) care. Depending on the circumstances, your (or your loved one’s) doctor may or may not recommend stopping use of the drug in question. Likewise, depending on any symptoms or complications you or your loved one has experienced, various forms of treatment may be necessary.

4. Make Informed Decisions About Your (or Your Family’s) Legal Rights

Along with making informed decisions about your (or your loved one’s) care, it is also important to make informed decisions about your (or your family’s) legal rights. When pharmaceutical companies sell dangerous drugs, they can—and should—be held accountable. In these scenarios, patients and families can hire a dangerous drug lawyer to fight for just compensation on their behalf at no out-of-pocket cost.

5. Avoid Making Assumptions Based Solely on What You Find Online

Finally, while resources like the FDA’s AEMS reporting system can be helpful, it is critical to avoid making any assumptions based solely on information you find online. Everyone’s circumstances are different, and what was appropriate for someone else in terms of seeking treatment or taking legal action may or may not be the right choice for you.

Contact an Experienced Dangerous Drug Lawyer at Searcy Denney

If you have questions about filing a claim related to a dangerous drug, we invite you to get in touch. Our lawyers have decades of experience holding the pharmaceutical companies accountable on behalf of patients and their families. To speak with an experienced dangerous drug lawyer at Searcy Denney in confidence, please call 800-780-8607 or request a free, no-obligation consultation online today.