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Abstral Safety Warning

Due to the high potential for abuse and overdose with Abstral (fentanyl sublingual tablets), the United States Food and Drug Administration issued a safety warning on how to properly use this pain medicine. This safety warning includes information on how Abstral should be prescribed, dosed, and taken in a safe manner. Also, anyone who uses this drug must be registered with a special program before beginning treatment.

An Introduction to the Abstral Safety Warning

Abstral® (fentanyl sublingual tablets) is a strong narcotic pain medication approved for the treatment of breakthrough cancer pain (intense flares of pain that "break through" routine pain medication). It comes in the form of a small tablet that is dissolved under the tongue.
Because it has a potential for abuse and overdose, Abstral contains a "black box" warning. Black box warnings are the strongest warnings issued by the United States Food and Drug Administration (FDA).

What Does the Abstral Black Box Warning Say?

The Abstral black box warning cautions healthcare providers to only use the medication in certain people and only at appropriate doses. The warning also emphasizes that Abstral has a high potential for abuse.

Who Is Abstral Appropriate For?

Abstral 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.
Abstral 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. Abstral could be dangerous if given in such situations.
Abstral contains fentanyl, a potent opioid medication. The amount of fentanyl in Abstral 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 the medication in a safe place, away from children and others who may accidentally or intentionally take it.
Like all opioid medications, Abstral 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 abuse, such as in people with a history of substance abuse (see Abstral Abuse for more information).
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Abstral Medication Information

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