“From 2011 to mid-2017, the FDA received more than 5.4 million reports of prescription drug adverse events, including more than 1 million deaths.”
Oct 16, 2020
DrugWatch.com – Even though the U.S. Food and Drug Administration may approve a drug or medical device for use, it may still cause side effects or complications for some patients.
Manufacturers, regulators and health care professionals have to weigh the benefits of a drug or device against its risks.
Sometimes this means comparing risks to benefits for the general population. Other times it may mean comparing risks to benefits for an individual patient.
For the most part, serious side effects and complications are rare.
But people taking medicines, undergoing surgery or receiving a medical implant should be aware of potential side effects.
What are Severe Drug Side Effects?
Severe side effects from drugs can range from infections to death.
If a drug has numerous reports of a particular problem, the U.S. Food and Drug Administration can add warnings to the drug’s label, including its stringent black box warning. In rare cases, the drug is recalled or removed from the market.
The FDA refers to side effects or other problematic consequences of drugs and medical devices as “adverse events.” Under federal regulations, adverse events include any unexpected or unfavorable medical occurrence whether it is related to the drug or not.
FDA serious adverse events include:
- Death
- A life-threatening condition
- Hospitalization
- Disability
- Congenital anomaly – any affect from prior to conception through pregnancy that may have an adverse outcome on the fetus or child
- Intervention required to prevent permanent impairment or damage
Drug Adverse Events
From 2011 to mid-2017, the FDA received more than 5.4 million reports of prescription drug adverse events, including more than 1 million deaths.
The agency keeps these reports in its FDA Adverse Events Reporting System (FAERS) database. Consumers can search for side effects of specific drugs reported to the FDA at the agency’s Public Dashboard … Read more.
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