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FDA Warnings on Actiq

The United States Food and Drug Administration has issued a special warning for Actiq, as this pain medication can cause potentially serious and life-threatening complications. This warning was issued to inform the public on how to safely use this medication. For instance, the FDA warning states that Actiq should only be prescribed to people who are accustomed to the effects of opioid medications.

An Introduction to the Actiq FDA Warning

Actiq® (fentanyl lozenge) is a strong narcotic pain medication licensed to treat breakthrough pain (pain that "breaks through" regularly scheduled narcotic pain medication) in people with cancer. It comes in the form of a lozenge, to be placed between the cheek and gums, and sucked.
Actiq has a "black box" warning from the United States Food and Drug Administration (FDA). Black box warnings are the most serious warnings issued by the FDA.

What Does the FDA Actiq Black Box Warning Say?

The Actiq black box warning cautions healthcare providers to only use the medication in certain people and only at appropriate doses. Serious problems, including deaths, have been reported when Actiq was used in people it is not approved for, or at improper doses. The warning also emphasizes that Actiq has a high potential for abuse. Finally, it recommends that Actiq only be prescribed by healthcare providers who have experience prescribing opioid medications.

Who Is Actiq Appropriate For?

Actiq is only approved for use in people who are already taking, and are tolerant to, around-the-clock opioid pain medication for underlying 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.
Actiq should not be used in people who just need pain medication for acute pain (pain that is expected to last a short time), pain after surgery, headaches, or migraine pain.
The amount of fentanyl in Actiq is enough to cause death in children. There have been reports of death in children who accidentally used the lozenges. Therefore, it is extremely important to keep the medication in a safe place, away from children at all times.
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