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FDA warns of potential serious side effects with Cephalon's cancer drug.


FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 on Sept. 26 alerted health care professionals and consumers over the use of Fentora, a breakthrough cancer pain drug manufactured by Cephalon Ceph´a`lon

n. 1. (Zool.) The head.
, after recent reports of deaths and other adverse events.

Fentora, a potent opioid opioid /opi·oid/ (o´pe-oid)
1. any synthetic narcotic that has opiate-like activities but is not derived from opium.

2. any of a group of naturally occurring peptides, e.g.
 pain medication, is used only for treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it.

Breakthrough pain is intense increases in pain that occur with rapid onset, even when opioid pain-control medication is being used. Patients who take narcotic narcotic, any of a number of substances that have a depressant effect on the nervous system. The chief narcotic drugs are opium, its constituents morphine and codeine, and the morphine derivative heroin.

See also drug addiction and drug abuse.
 pain medications daily and around-the-clock develop tolerance and are more resistant to the dangerous side effects Side effects

Effects of a proposed project on other parts of the firm.
 of these medications than patients who take narcotic pain medication on a less frequent basis.

The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

In its Public Health Advisory and Health Care Professional Sheet, FDA warned physicians and other health care professionals that it is critical to follow product labeling when administering Fentora.

FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines (tool) MIGRAINES - A graphical user interface for evaluating and interacting with the Aspirin neural network simulation.

Utilities exist for moving quickly from an Aspirin description of a network directly to an executable program for simulating and evaluating that network.
. It is critical that Fentora not be used in patients who are not opioid tolerant.

Patients also must be under a doctor's care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately, the agency stated.

In addition, FDA is concerned about the improper substitution of Fentora, a quick-acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and  products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain.

Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose.

On Sept. 10, Cephalon sent letters to physicians and other health care providers advising them about the adverse events and deaths reported for Fentora. FDA is reviewing available information including adverse events.

The agency has asked the company to strengthen warnings and improve the dosing instructions in the drug's product labeling. FDA also requested that the company improve their education plan for prescribers and pharmacists This is a list of notable pharmacists.
  • Dora Akunyili, Director General of National Agency for Food and Drug Administration and Control of Nigeria
  • Charles Alderton (1857 - 1941), American inventor the soft drink Dr Pepper
  • George F.
 on the proper patient selection, dosing instructions and restrictions on substituting Fentora for other products.
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Title Annotation:Warnings/recalls
Publication:Adverse Event Reporting News
Date:Oct 8, 2007
Words:369
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