How to Report Adverse Reactions to Prescription Medications

Adverse reactions to prescription medications are alarmingly common. As a result, if you have experienced an adverse reaction to a drug that your doctor prescribed, you are not alone. Reporting adverse reactions allows for nationwide tracking, and this helps the U.S. Food and Drug Administration (FDA) determine when recalls are necessary.

3 Ways to Report Adverse Reactions to Prescription Medications

There are three primary ways to report adverse reactions to prescription medications. All three involve reporting to the FDA—they just involve different means of doing so. As the FDA explains:

“MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions [to prescription] drugs . . . . In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. . . . Your report may be the critical action that prompts a modification in use or design of [a drug], improves its safety profile and leads to increased patient safety.”

So, how do you report an adverse reaction to MedWatch? The three primary options are:

1. File a Reporting Form with the FDA

The first option is to contact the FDA yourself. You can do so by filing Form 3500B with the FDA. Patients can download Form 3500B and mail it to the FDA or complete and submit the form online.

Whichever options you choose, you will want to read the FDA’s Frequently Asked Questions, and you will need to take your time to complete the form accurately. If you omit any required information or provide any information that is inaccurate, the FDA may not be able to accept your report in MedWatch. If you decide to mail in your completed Form 3500B, you will need to use the FDA’s mailing address at the bottom of the last page of the form.

2. Ask Your Doctor to Submit Your Reporting Form

Instead of filing Form 3500B yourself, you can ask your doctor to submit your reporting form for you. The FDA recommends this approach, stating, “[i]f you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor.” As the FDA goes on to explain, this is because “[y]our health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.”

While some doctors will be happy to assist with reporting adverse drug reactions to MedWatch, others will not. If your doctor is not willing to help, you can submit your report yourself or seek help from a defective drug lawyer.

3. Get Help from a Defective Drug Lawyer

A defective drug lawyer can assist you with reporting an adverse reaction to a prescription medication to the FDA. An experienced lawyer will be intimately familiar with Form 3500B and will be able to help you submit all the required information. Aside from submitting your completed Form 3500B to the FDA, your lawyer will keep all information you share strictly confidential—and, as we discuss below, there are several other ways an experienced defective drug lawyer can assist you in this situation as well.

Other Reasons to Talk to a Defective Drug Lawyer After an Adverse Reaction

Along with reporting your adverse reaction to the FDA, there are several other ways an experienced defective drug lawyer can help you. In addition to getting help with Form 3500B, other reasons to talk to a defective drug lawyer after an adverse reaction include:

• Finding Out if You Have a Defective Drug Claim – Patients who experience adverse reactions to prescription medications will have defective drug claims in many cases. When pharmaceutical companies sell dangerous and defective drugs, they can (and should) be held fully accountable for the financial and non-financial costs patients and their families incur.
• Finding Out if You Have a Claim Against Your Doctor – Sometimes, doctors won’t want to help their patients report adverse reactions because they know that they prescribed dangerous drugs. If your doctor could (and should) have helped protect you, you may have a claim against your doctor as well.
• Determining How Much You Are Entitled To Recover – If you have a claim against a pharmaceutical company or your doctor (or both), you are entitled to just compensation for all of the financial and non-financial costs of your adverse reaction. Your lawyer can help you understand how much you are entitled to recover so that you can make an informed decision about whether to take legal action.
• Seeking Just Compensation for Your Adverse Reaction – If you decide to take legal action, your lawyer will seek just compensation for your adverse reaction on your behalf. This is a complex legal process that requires highly experienced legal representation.
• Ensuring that You Are Making Informed Decisions – From deciding whether to take legal action to deciding whether to settle your claim, working with an experienced defective drug lawyer will allow you to make informed decisions throughout the process. The financial and non-financial costs of adverse reactions can be substantial, and you only get one chance to seek the financial compensation you deserve. As a result, it is critical that you have an experienced lawyer on your side.

While reporting an adverse reaction to a prescription drug is important, the reality is that this won’t help you deal with your current situation. But, taking legal action will. Learning about your legal rights costs nothing, and if you have a claim for a defective drug, you can hire an experienced lawyer to handle your claim at no out-of-pocket cost to you.

Talk to a Defective Drug Lawyer at Searcy Denney

If you need help reporting an adverse reaction to a prescription medication, we strongly encourage you to get in touch. We are more than happy to assist you in any way we can. To arrange a complimentary initial consultation with a defective drug lawyer at Searcy Denney, please call 800-780-8607 or get in touch online today.