Fentora Side Effects Lawsuit

Fentora Side Effects Lawsuit

Fentora, a fentanyl buccal tablet, is used for the management of severe pain in cancer patients who already are receiving, but are tolerant to, opioid therapy for their core persistent cancer pain. Fentora is a potent opioid analgesic that is intended for buccal mucosal administration. The drug is a round, flat faced, beveled-edge, white tablet.

Fentora contains the OraVescent drug delivery technology. OraVescent drug delivery technology generates a reaction that allows the tablet, when combined with saliva, to releases carbon dioxide. It is believed that transient pH changes along with the reaction may optimize the dissolution of fentanyl at a lower pH and the membrane permeation of fentanyl at a higher pH through the buccal mucosa.

Fentora Side Effects Lawsuit

Fentora is designed to be placed in the buccal cavity ant be retained there for a sufficient period to allow the tablet to disintegrate and to allow the fentanyl to be absorbed across the oral mucosa.

The active ingredient in Fentora is Fentanyl citrate. Fentanyl citrate USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate. Fentanyl is a greatly lipophilic compound, octanol-water partition coefficient at pH 7.4 is 816:1, and is soluble freely in organic solvents and sparingly soluble in water. The molecular weight of fentanyl is 336.5 and the citric salt is 528.6. The free base’s pKa of tertiary nitrogens are 7.3 and 8.4. 

Fentora is used to treat patients with cancer that are tolerant to opioid therapy. The patients who are considered to be tolerant to opioid therapy are taking a minimum of 60mg/day of oral morphine, a minimum of 25mcg/hour of transdermal fentanyl, a minimum 30mg of oxycodone daily, a minimum of 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a period of week or longer.

Fentora Side Effects Lawsuit

Fentora must not be used in opioid non-tolerant patientsLife threatening hypoventilation could occur, at any dose not on a chronic regimen of opiates, when Fentora is used in patients that are not tolerant to opioid therapy and. The drug is intended for use only by healthcare professionals who are knowledgable in the treatment of cancer patients using Scheduale II opioids.

Treatment with Fentora should be individualized by the physicians using a progressive plan of pain management. The appropriate pain management principals of careful assessment and ongoing monitoring should be followed by the healthcare professionals administering the drug.

The lowest possible dose should be administered to patients with hepatic and/or renal impairment and the lowest possible dose should also be administered to patients receiving CYP3A4 inhibitors.   Caution should be exercised for patients with hepatic and/or renal impairment and for those receiving CYP3A4 inhibitors.

The initial dose of Fentora should be 100mcg. If one Fentora dose does not adequately relieve pain, dose can be repeated once during a single episode of breakthrough pain. 30 minutes after the initiation of the administration of Fentora, Re-dosing may start and the same dosage should be used as the initial dose. Patients should be closely followed after the initial dose of Fentora and the dosage strength should be changed until the patient reaches a dose that provides sufficient analgesia with tolerable side effects using one single Fentora tablet.

7 blister cards with 4 white tablets in each card is contained in each carton.

Some Fentora Side Effects Lawsuit and adverse events associated with Fentira include:

·         Anemia

·       Neutropenia

·       Nausea

·       Constipation

·       Diarrhea 3

·       Abdominal pain

·       Edema peripheral

·       Asthenia

·       Fatigue

·       Weight loss

·       Dehydration

·       Anorexia

·       Hypokalemia

·       Back pain

·       Arthralgia

·       Cancer pain

·       Dizziness

·       Headache

·       Somnolence

·       Confusional state

·       Depression

·       Insomnia

·       Cough

·       Dyspnea

The FDA and the Centers for Disease Control and Prevention are now collaborated earlier this year on the issue of opioid use and the accidental, often fatal overdoses associated with opioid use.

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