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Onsolis Safety Warning

The United States Food and Drug Administration has issued a "black box" safety warning for Onsolis (fentanyl buccal soluble film) to inform people how to safely use this pain medication. Onsolis is a strong narcotic that can cause potentially dangerous and even life-threatening complications. To help prevent abuse and overdose, people who use this medication have to be enrolled in a certain safety program.

An Introduction to the Onsolis Safety Warning

Onsolis™ (fentanyl buccal soluble film) is a strong narcotic pain medication approved for treating breakthrough pain (intense flares of pain that "break through" routine pain medication) in people with cancer who are already using another opioid pain medication. It comes as a small film that is dissolved inside the cheek.
Onsolis contains a "black box" warning, the strongest warning issued by the United States Food and Drug Administration (FDA). The black box warning describes important safety information about Onsolis.

What Does the Black Box Warning Say?

This warns healthcare providers that special precautions must be taken to ensure Onsolis is used safely. It should only be used in certain people, and only with special dosing guidelines. The warning also stresses that Onsolis has a high potential for abuse.

Who Is Onsolis Appropriate For?

Onsolis is only approved for use in people who are already taking, and are tolerant to, around-the-clock opioid pain medication for constant cancer pain. In general, people are considered opioid tolerant if they have been taking regular, around-the-clock doses of opioid narcotics for at least a week.
Onsolis should not be used in people who just need pain medication for acute pain (pain that is expected to last a short time), including pain after surgery or other medical or dental procedures, headache or migraine pain, or pain in an emergency room setting. Onsolis could be dangerous if given in such situations.
Onsolis contains fentanyl, a potent opioid medication. The amount of fentanyl in Onsolis could cause death if taken by a child, someone for whom the medication was not prescribed, or someone who is not tolerant to the effects of opioid medications. Therefore, it is extremely important to keep this product in a safe place, away from children and others who may accidentally or intentionally use the medication.
Like all opioid medications, Onsolis has a high potential for abuse. Because of this, it is classified as a Schedule II federally controlled substance. Special care should be taken if this medication is used in situations where there may be a risk of abusing this drug, such as in people with a history of substance abuse (see Onsolis Abuse for more information).
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