MedWatch is an FDA program for reporting “serious reactions” resulting from a prescription medication. The FDA is particularly interested in those drug injury events which resulted in any of the following outcomes:
- Patient’s Death: an adverse reaction to a drug is the suspected cause of death
- Life-Threatening Condition: a serious side-effect put the patient at real risk of dying
- Hospitalization: the person is admitted to the hospital because of their serious adverse reaction to a medication
- Permanent Disability: strokes; nervous system disorders; other impairment
- Birth Defect or Birth with Disease: congenital anomaly; adverse outcome to a child
- Needs Medical Intervention to Avoid Permanent Damage: medical treatment is required
The FDA encourages patients to take the Reporting Form to their treating doctor when it is known or suspected that they have been seriously harmed by a pharmaceutical product. However, it is important to understand that this physician is not required to make a report to the FDA, even if you ask them to do so.
For this reason, and because there may be circumstances when a person does not want to go back to their doctor to ask for help with a drug injury report, patients can submit their information directly to the FDA. There is an online reporting form available through the FDA website.
To report online, you can use the MedWatch Online Voluntary Reporting Form (3500).
Form FDA 3500B (a PDF form that can be filled out online) is a consumer-friendly voluntary reporting form that contains less technical language than the online FDA Form 3500.
MedWatchLearn is a web-based learning tool designed to educate medical students, doctors or other health professionals, and consumers on reporting in a way that provides the best information for FDA reviewers to further investigate medical product problems.
Lastly, you can use the toll-free telephone number for reporting a suspected drug injury to the FDA: 800-FDA-1088.
Be assured that the patient’s identity will be held in strict confidence by the FDA. In addition, the FDA will not disclose the identity of the person who submitted the report, be it the doctor, the patient, a family member, a health care provider, or some other concerned person.
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