Prescription drug abuse is on the rise in Indiana.
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The changes will include a new warning on all immediate-release opioids about the serious risk of misuse, abuse, addiction, overdose and death from use of the drugs.
Earlier this month, The Centers for Disease Control and Prevention (CDC) announced new voluntary guidelines for medical professionals about when and how much opioid medication is appropriate to prescribe for chronic pain.
FDA Commissioner Robert Califf in a release described opioid addiction as one of the most “urgent and devastating public health crises facing our nation” and adding more warnings was just part of a layered strategy in addressing the concern on the heels of criticism for not taking enough initiative to counter the abuse.
The agency said it would also require several additional safety labeling changes across all prescription opioid products to include information on the risk of those medications.
The new labels update information about dosage for the patient including the size of the initial dose, how to monitor patients using opioids and a warning not to abruptly stop treatment for a physically dependent patient. But, Califf emphasized that these drugs be kept to use for severe pain where no alternative medications are available.
Bill Soller, president of Biomedical Regulatory Consulting in Houston, an expert on drug labeling when he was a professor at UC San Francisco, believes in the “comprehensiveness” of the FDA strategy.
Doctors will “prescribe opioids to a patient with acute pain, along with a benzodiazepine to treat muscle spasms”.
Throckmorton said the agency’s 2013 labeling change focused on long-acting drugs like OxyContin because they represented a “disproportionate risk” to patients, since they contain larger opioid levels. Immediate-release opioids account for about 90 percent of opioid prescriptions, while extended-release drugs, meant to be taken once or twice a day, make up the rest, the F. D.
As soon as consumers get their prescription filled, the bottle should have a notice that indicates there is a black box warning for the drug.
Markey’s reaction to the FDA’s March 22 announcement was mixed.
“We know that there is persistent abuse, addiction, overdose mortality with IR opioid products”, said Dr. Throckmorton. “Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone”. Certain opioids, such as methadone and buprenorphine, are also used as a form of treatment for opioid addiction, and in combination with behavioral therapy and counseling, are known as medication-assisted treatment, or MAT.
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The move is one of a series announced recently by the FDA as it seeks to tackle the problem of opioid overdose and death.
