Painkiller drug Fentora's causing several patient deaths causes Cephalon to address the doctors with a letter pointing to correct prescription.
Dear Healthcare Professional Letter
On September 13th, 2007, Cephalon, Inc. issued a Dear Healthcare Professional Letter to inform health care providers about key safety information regarding the use of FENTORA (fentanyl buccal tablet) [C-II]. The following information is meant to emphasize key points about appropriate patient section and proper dosing and administration:
- Do NOT use FENTORA in opioid non-tolerant patients
- Use FENTORA only for labeled indications
- Do not prescribe FENTORA for patients with acute pain, postoperative pain, headache/migraine, or sports injuries
- FENTORA is not a generic version of Actiq. Therefore, do NOT substitute FENTORA for Actiq or other fentanyl-containing products
- Follow dosing instructions carefully:
o For unrelieved breakthrough pain (BTP), patients should NOT take more than 2 FENTORA tablets per BTP episode
o Patients MUST wait at least 4 hours before treating another BTP episode with FENTORA
The most common (>10%) adverse events observed in all FENTORA clinical trials were nausea, dizziness, vomiting, fatigue, headache, constipation, anemia, somnolence, and peripheral edema. Most side effects were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.
In addition, application site reactions were reported in 9% of patients, tended to occur early in treatment, were self-limited, and resulted in treatment discontinuation for only 2% of patients.