Fentora is used only for treating breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it- those who take a regular, daily, around-the-clock narcotic pain medicine. Breakthrough pain is intense increases in pain that occur rapidly, even when opioid pain-control medication is being used.
People who develop tolerance to narcotic pain medicines are more resistant to the dangerous side effects of these medications than those who take narcotic pain medication less frequently.
The deaths reported indicate that some cancer patients
Important Safety Information{mosimage}
Fentora should not be used to treat any type of short-term pain, including headaches or migraines, pain after an operation, or pain due to injury.
People who only take narcotic pain medications occasionally should not use Fentora.
Do not substitute Fentora for other fentanyl medicines, including Actiq. The dosage strength of fentanyl in Fentora is NOT equal to the same dosage strength of fentanyl in other fentanyl-containing products. Using the same dose can result in a fatal overdose.
Read the Medication Guide that comes with Fentora,and follow the directions exactly.
Watch For These Signs
Get medical attention right away if you have any of these signs:
FDA Actions
requested the company improve their education plan for prescribers and pharmacists
published a Public Health Advisory and Health Care Professional Sheet warning health care professionals that it is critical to follow Fentora’s product labeling
monitoring the Fentora issue closely and reviewing available information, including adverse events
working with the manufacturer to ensure the safest use of the medicine
providing updates as new information is available
Adverse events related to Fentora should be reported to MedWatch, the FDA’s voluntary reporting program:
Website: www.fda.gov/medwatch/report.htm
Phone: 800-332-1088
Fax: 800-332-0178
Mail to:
MedWatch Food and Drug Administration 5600 Fishers Lane Rockville, MD 20852-9787For more information, see Fentanyl Buccal Tablets (marketed as Fentora)
Source: U.S Food and Drug Administration
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Catharine “Kate” is a Certified Administrator for Residential Care Facilities for the Elderly (RCFE) and an Expert Senior Care Advisor. Kate’s grandmother battled Alzheimer’s Disease and Kate personally understands what millions of families are going through. Kate and her team are very passionate in empowering Seniors and their families by providing them with the Best Available Senior Care Options based on Senior’s care needs, preferred location and family’s budget.
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