Question

Scenario 1: You are treating your patient with acute UTI with the aminoglycoside antibiotic gentamicin. While the patient is taking gentamicin, acute tubular necrosis (epithelial cells in the renal tubules of the kidney) develops that requires intermittent dialysis before recovery.

Scenario 2: You prescribe the recently approved drug aliskiren (Tekturna), a direct renin inhibitor, for hypertension in your patient. One week after starting the drug, your patient reports edema involving the face and hands; no clear respiratory symptoms can be elicited.

For each scenario-

1. Should any of these incidents be reported to the US Food and Drug Administration (FDA)? If so, how is this done?
2. What are the benefits to you the provider, or to the public if this information is reported?
3. What are the requirements of the manufacturer to report to the FDA instances of these events?

Answer 1

The U.S Food and Drug Administration protects the public health by helping to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and products that emit radiation.

One can submit online or written comments on any guidance at any time.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

One can report a problem to the FDA online, via phone, or via mail.

For emergencies:

- Call 9-1-1 immediately.

- In limited emergency situations(which are urgent but not life-threatening), you or your health care professional can report problems to the FDA’s emergency line at 1-866-300-4374 or 301-796-8240. The line is open 24 hours a day, every day of the week.

For non - emergencies - To report online or via mail, visit the FDA non-emergency reporting page. There you’ll see exactly where to report problems with specific, regulated products.

Submit as much detailed information as possible.

* Try to provide the following information.

- Name of the person affected—including age, sex, and ethnicity—to help the agency determine if particular groups are especially affected. (The FDA is committed to protecting confidentiality of patients. For privacy reasons, do not use a person’s social security number as an identifier.)

- If reporting about a prescription or over-the-counter drug, the name of the drug, manufacturer, and the strength of the drug.

- If reporting about a tobacco product, the product type, brand name, and manufacturer.

- Name and address of the store where you bought the product and the date of purchase.

- Details about the problem, such as symptoms and whether the issue went away after you stopped using the product.

- Any medical treatments and outcomes.

## - For the safety of the public health, the adverse effects of the drug information should be reported.

- If reported, then the required actions would be taken for the improvement of the drug and that would be benificial for the health of all.

- It will help in keeping track of the drastic effects of drugs.

- Improve public health and safety in relation to the use of medicines.

- It will Contribute to the assessment of benifit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective use.

# Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury.

These data elements are required for valid adverse event submissions and are evaluated during inspections:

• Identifiable patient

• Suspect drug or biological product

• Adverse event or report of death

• Identifiable reporter

There are no legal requirements for a consumer to report adverse events. A patient should report if they had a significant outcome – such as having to go to the hospital as a result of a medication they took or if they have to stop taking the medication because of an adverse event. FDA encourages patients to report adverse events as soon as possible. If the adverse event team gets a cluster of reports about the same drug in a short period of time, they will be able to respond more quickly.