FDA Requires New Warning Labels on Addictive Medication

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FDA Requires New Warning Labels on Addictive Medication

The U.S. Food and Drug Administration (FDA) announced yesterday safety labeling changes for immediate-release (IR) opioid pain medications. There now must be warnings on the medications about the risks of addiction, abuse, misuse, overdose and deaths. This change hopes to curb the addiction epidemic while still providing relief to patients with pain.

Immediate-release medications are a type of opioid that is taken every 4 to 6 hours. These are only prescribed when the pain cannot be treated with other alternatives. Some common types of IR medications are Oxycodone and morphine.

The new labels will also include clearer instructions about monitoring patients and their dosages. It will contain a warning to not abruptly stop treatment in dependent patients and precaution that these medications could lead to neonatal opioid withdrawal syndrome in pregnant patients.

 

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