On October 24, 2016, FDA Voice provided an update on the progress of the U.S. Food and Drug Administration (FDA) Opioid Abuse Action Plan. According to Robert M. Califf, M.D., the Deputy Commissioner of the United States Food and Drug Administration’s Office of Medical Products and Tobacco, the plan to address problems with opioid abuse has made significant strides.
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FDA Opioid Abuse Action Plan Progress
At this point, the FDA has accomplished several of the goals expressed in their original Action Plan.
This includes the implementation of new, stronger warnings on the product labels of prescription opioid analgesics and opioid-containing cough products. The FDA has also issued a draft guidance for industry to support the development of generic versions of approved opioids with abuse-deterrent formulations. Additionally, the FDA now requires that sponsors must conduct a number of studies to generate post-market data on the safety of their opioid products.
These new policies are merely a few of the actions taken by the FDA to address the growing problem of opioid abuse.
CDC Information on Prescription Opioids:
Prescription opioids can be used to help relieve moderate-to-severe pain and are often prescribed following a surgery or injury, or for certain health conditions. These medications can be an important part of treatment but also come with serious risks.
Prescription opioids carry serious risks of addiction and overdose, especially with prolonged use. An opioid overdose, often marked by slowed breathing, can cause sudden death. The use of prescription opioids can have a number of side effects as well, even when taken as directed:
• Tolerance—meaning you might need to take more of a medication for the same pain relief
• Physical dependence—meaning you have symptoms of withdrawal when a medication is stopped
• Increased sensitivity to pain
• Constipation
• Nausea, vomiting, and dry mouth
• Sleepiness and dizziness
• Confusion
• Depression
• Low levels of testosterone that can result in lower sex drive, energy, and strength
• Itching and sweating
