Fentora, a strong narcotic painkiller is approved by FDA to treat intense breakthrough pain in cancer patients who can take narcotic pain medicines around the clock. Such intense pain increases in bursts with rapid onset even when pain-control medication is being used.
The Frazer, Pennsylvania-based company issued warning letters to doctors earlier this month after three patients died consuming the drug outside of its approved uses.
The FDA has cautioned people against taking Fentora for migraines or other types of short-term pain. The federal agency also asked health care professionals who prescribe Fentora to make their patients aware of the signs of fentanyl overdose.
According to WebMD, signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness, or sedation; inability to think, talk, or walk normally; and feeling faint, dizzy, or confused.
Moreover, the FDA has also asked Cephalon to strengthen warnings and improve the dosing instructions on the drug's label. The company says it is working with the FDA on this issue.
