FDA finally adds black box warnings labels to the most widely-used single-dose painkillers

FDA finally adds black box warnings labels to the most widely-used single-dose painkillers

After years of foot-dragging, the Food and Drug Administration (FDA) has finally decided to call for its most stringent “black box warnings” to be added to the labels of some 175 generic and brand-name opioid immediate-release (IR) prescription painkillers. The targeted drugs are among the most commonly prescribed drugs in the country and account for 90 percent of all opioid painkillers prescribed. The new labels will include a warning about the risks for misuse, abuse, addiction, overdose and death. This latest move is part of the federal government’s broad new campaign addressing the country’s epidemic of opioid abuse, addiction and overdose fatalities linked to prescription opioid painkillers as well as to heroin. The agency added similar boxed warnings to extended-release (ER) prescription opioids three years ago, because of the perceived increase in danger from the substantially larger amount of opioids in each tablet. Since then, thankfully, some light-bulbs have finally begun to light up in Washington, illuminating the fact that all prescription opioids are deadly, and all of them are playing a role in the annual death toll of over 19,000 Americans a year. The dosing information will also be updated, and instructions have been improved about patient monitoring and drug administration such as initial dosage and dosage changes during therapy.

Pay more attention to patients

There also will be a warning not to abruptly stop treatment in a physically dependent patient. Any doctor worthy of a license to practice already knows that. What they often don’t bother with is monitoring patients closely enough to know if the patient is dependent, or worse, abusing or addicted. The FDA also now warns doctors about another well-known but frequently ignored danger –long-term opioid use during pregnancy. Opioids and expectant moms are a very bad idea, because it can lead to “neonatal opioid withdrawal syndrome” – a horribly painful and difficult-to-treat dependence in the newborn. And if not recognized and treated it is potentially life-threatening. “We are also working to improve the information available to patients by requiring medication guides to help them avoid serious adverse effects of IR opioids,” said Dr. Douglas Throckmorton from the FDA’s Center for Drug Evaluation and Research in regard to black box warnings. This new announcement is not related to a petition sent recently to the FDA about the much higher risk of fatal overdose when prescription opioids and benzodiazepines are consumed together. Signed by 41 noted public health and academic officials, the petition urged the FDA to add special boxed warnings on the labels of all prescription opioids and benzodiazepines. But the FDA also announced that it is reviewing the scientific information about the potentially serious outcomes related to interactions between opioids and benzos. FDA Commissioner Robert Califf, MD, said that “while the FDA alone can't solve this crisis, we are committed to working with other government agencies, healthcare providers, medical products industry and most importantly patients and their families to prevent abuse, save lives and treat dependence while still providing patients in pain access to effective relief.”

Here at Novus, we help a lot of people free themselves from the negative effects of prescription opioids. Our medical opioid detox protocols are uniquely effective at detoxifying from the drugs while dramatically reducing the discomfort usually associated with opioid withdrawal. If you or someone you care about needs some help with a drug or alcohol problem, don’t hesitate to call Novus. We’re always here to help.

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