3 Ways to Report an Adverse Medication Reaction

I recently spoke with a woman over 65 who was recovering from a serious adverse reaction to a prescription drug. She notified her doctor and stopped taking the medication, but she wanted to do more. She was concerned that in the future, others might experience similar reactions. There are several reasons why women over 65 may be more likely to experience an adverse event, but the good news is we can help protect each other by alerting FDA.

As we age, drugs clear from our systems more slowly, meaning their effects on us may be different. Nevertheless, the clinical trials for many medicines currently on the market excluded older adults. On top of that, many drugs still being prescribed were developed at a time when women and persons of color were underrepresented in clinical trials–or excluded altogether.

And, as I’ve written about previously, the Food and Drug Administration typically mandates combination testing for new prescription drugs with just a few other medications that are likeliest to be co-prescribed. Those are pair tests; there is typically no testing of a new drug in combination with two or more approved medications. Yet the average American over 65 reports taking four or more prescription medications, which may interact in ways that have not been studied.

All this means that reports to FDA are the best way for the agency to learn about safety problems with an approved drug. If you or someone you care about has an adverse reaction to a medication, here are three ways you can escalate your concerns to FDA.

Adverse Reports

• File a MedWatch report:

Anyone who takes a medication and experiences an adverse reaction can report it directly to FDA by filing a MedWatch report. You can report unexpected side effects or adverse events — everything from a skin rash to more serious problems. The report can be filed online and you can include your contact information in case FDA staff has follow-up questions.

• Ask Your Doctor to File a MedWatch Report:

FDA is prohibited from regulating the practice of medicine. As a result, physician reports to FDA are voluntary for adverse reactions to approved drugs. However, FDA welcomes doctors’ reports of adverse events. They even have a form designed only for reports by healthcare professionals. When you talk with your doctor about your adverse reaction, you can encourage them to make a report via the physician reporting page on the FDA website. As one medical journal article on the subject points out, “While this takes time, physicians have an ethical obligation to participate in recognizing and reporting ADR [Adverse Drug Reactions].”

• Report Your Adverse Event to the Drug Manufacturer:

Look for information about filing a medication complaint on the website of the company that produced your medicine. If your reaction is significant, the manufacturer is required to make a report to FDA within days of receiving your complaint. And all adverse reactions reported to the manufacturer, regardless of severity, must be logged and made available on the next periodic inspection by the local FDA district office. The inspector will ensure that these complaints have been properly evaluated by the manufacturer. The inspector will then make sure that necessary corrective actions in manufacturing and testing are made.

All three of these reporting methods are important. Your MedWatch report will be reviewed by personnel at FDA headquarters in Bethesda, who look for patterns in complaints that can ultimately lead to warnings on drug labeling or even to withdrawal of an unsafe drug from the market. When you encourage your physician to submit your adverse event, their report adds weight to the seriousness of the complaint. And by filing a complaint with the manufacturer, you alert FDA local inspectors who can mandate improvements on the ground.

To report an adverse event is important for public health. As FDA says on the physician reporting page, “You and your patient’s report may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the drug or device and leads to increased safety.”

And one last thought: While problems with medical devices can also be reported via MedWatch, vaccines have their own reporting system. If you have an adverse reaction to a vaccine, you and your physician can report it to the Vaccine Adverse Event Reporting System (VAERS).

When you have a health condition that requires a new medication, be sure to ask your doctor any questions you may have. Check to see whether the prescribed medication is on the Beers List (formally, the Beers Criteria for Potentially Inappropriate Medication for Older Adults). And if you experience an adverse reaction, do a good deed and report it. The more FDA staff learns about drugs that are already on the market, the better they can protect the public health.