MedWatch is the US system of reporting to the FDA (Food and Drug Administration), which encourages consumers and doctors to report a serious adverse reaction to a medicine or medical device. It is voluntary and plays a critical role in the FDA’s post-marketing surveillance of an approved drug/product. Drug Adverse Reaction reports are evaluated along with those received from manufacturers and can result in safety alerts, labeling changes with stronger side effect warnings, or even the withdrawal of the drug from the market. That is why it is important for all consumers to report psychiatric drug side effects.
To log onto the FDA’s MedWatch reporting system click here.
Other countries often have similar reporting systems, which you should get fully informed about to report an adverse reaction from medication of any sort. Some examples are listed:
Australia’s Therapeutic Goods Administration (TGA) has an “Adverse Medicines Event Line.” To go to their reporting system, click here.
Health Canada’s Adverse Reaction Reports can be submitted online. To make a report, click here. (Also available in French).
New Zealand’s Medsafe Center for Adverse Reactions Monitoring (CARM). To go to CARM’s official website, click here.
UK’s Medicine and Healthcare Products Regulatory Agency (MHRA) has a system called “Yellow Card.” For reporting online, click here.
NOTE: If you cannot easily report an adverse drug reaction through your country’s drug regulatory agency, write a letter to the agency and your federal representative on the need to make this system consumer-friendly—i.e., very easy to file a report.