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FDA Requires “Black Box” Warning about Painkiller Abuse

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FDA Requires “Black Box” Warning about Painkiller Abuse

March 29, 2016

The US Food and Drug Administration (FDA) recently announced that it will now require makers of immediate-release opioid painkillers to include a “black box” warning about the health risks associated with their products.

The warning has been deemed necessary in the wake of numerous reports of prescription drug overdoses across the country. Painkillers like oxycodone and fentanyl are being abused at record rates in New Jersey, New York and elsewhere in the United States. Health officials have previously referred to prescription drug abuse in this country as an “epidemic.”

Generally speaking, prescription painkillers that are sold in the US can be classified as either “extended release” or “immediate release.” Extended release painkillers have a higher percentage of opioids than immediate release painkillers; however, immediate release painkillers end up causing drug addiction because they need to be taken far more frequently in order to be effective. According to the FDA, approximately 90 percent of all opioid prescriptions are for the more addictive immediate-release category of painkillers.

Now the FDA is fighting back against the alarming rise in prescription drug abuse, addiction, overdoses and death by requiring prescription drug distributors to include a black-box warning on bottle labels. This type of warning is the strongest one issued by the FDA. Basically, it provides patients with a notification that the prescription drug they are about to use could have serious health consequences. Each black box warning will contain a prompt for the consumer to visit the manufacturer’s website to learn more about the potential adverse effects of the prescription painkiller. Additionally, pharmacists will be encouraged to provide patients with a guide on how to properly use the prescription medication.

For more information about the recent FDA decision, view the CNN.com article, “FDA Requires ‘Black Box’ Warning on Painkillers.”


If you or a loved one has been arrested for prescription drug possession, simple possession of marijuana, heroin possession or any other drug crime in New Jersey, the aggressive criminal defense lawyers at Rudnick, Addonizio, Pappa & Casazza PC can help you. Contact us now to schedule a free consultation about your case.

“The attorney working on my personal injury case was knowledgable, courteous, and payed careful attention to every detail. He was sure to address any questions and concerns thoughtfully and respectfully. I have had an excellent experience interacting with the firm and I highly recommend the law firm of Rudnick, Addonizio, Pappa & Casazza to others.”

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