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FDA Sets New Strict Safety Guidelines on Opioid Painkillers

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Shalini Shah2 years ago

This week the U.S Food and Drug Administration (FDA) set broad safety guidelines requiring some opioid pain drugs to carry the strongest safety warnings.

About the Strict Safety Guidelines

The FDA has set stricter guidelines to help fight the epidemic of opioid addiction and overdose. The main reason for America’s drug overdose epidemic is the overprescribing of opioids, largely for chronic pain. 

These stricter guidelines have come after the U.S Centers for Disease Control and Prevention (CDC) released voluntary guidelines instructing primary care doctors to sharply reduce the use of opioids for chronic pain.

The FDA has claimed the short-acting opioid pain medications would be required to carry on their labels the strongest form of a warning about the risks of misuse, abuse, addiction, overdose, and death.

Reuters reports the FDA is requiring extra safety labeling changes across all prescription opioid products to include more information on the risk of these medications.

The agency had said its plan is aimed at reversing this epidemic while providing access to effective pain relief.

Opioid Addiction and Overdose Statistics

Prescription Opioids can be prescribed by doctors to treat moderate to severe pain, but have serious risks and side effects. The CDC recommends that doctors should partner with patients to provide safer, more effective pain management. The CDC reports the following statistics:

  • Opioids killed more than 28,000 people in 2014
  • About half of all opioid overdose deaths involve a prescription opioid
  • Almost 2 million Americans abused or were dependent on opioids in 2014
  • Since 1999, sales of prescription opioids in the U.S have quadrupled 


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