Actiq Lawsuit

What is an Actiq Lawsuit?

Actiq, which is the brand name for Fentanyl, is used to treat sudden episodes of pain that occur regardless of treatment with stock medication. Actiq is prescribed only to cancer patients at least 18 years of age who take regular dosages of opiate and are tolerant to other narcotic pain medications. As a treatment for breakthrough pain, Actiq is in a class of medications called narcotic analgesics. It is effective by altering the way the brain and nervous system respond to pain.
Actiq comes as a lozenge on a handle that is to be dissolved in the mouth. Actiq is used as needed but should not be taken more than four times per day. Doctors typically start patients on low doses of Actiq, then gradually increase their dose until they find the right amount of Actiq to relieve breakthrough pain.

Before taking Actiq, you must inform your doctor of the following:

• To minimize the presence of Actiq side effects, inform your doctor and/or pharmacist of any allergies to fentanyl patches, nasal sprays, injections, lozenges, tablets or films

• To reduce the risk of developing Actiq side effects, tell your doctor and pharmacist what other prescription and nonprescription medications, nutritional supplements and vitamins you are taking or planning to take. Be sure to mention the drugs listed in Actiq’s important warning section.

• Tell your doctor if you are pregnant or planning to become pregnant. Also, to minimize the risks of Actiq side effects, tell your doctor if you are having any kind of surgery.

• Never drink alcohol with Actiq. Alcohol increases the risk that you will encounter severe Actiq side effects.

• If you are diabetic, understand that Actiq contains roughly 2 grams of sugar.

The presence of Actiq side effects may be unavoidable. Please inform your doctor if these Actiq side effects are persistent or particularly bothersome:

• Actiq side effects include drowsiness, stomach pain, vomiting and nausea

• Actiq side effects include loss of appetite, weight loss, difficulty urinating, bad gas and diarrhea

• Headaches, anxiety, changes in vision, depression and hallucinations are commonly observed Actiq side effects

• Unusual dreams or thinking are observed Actiq side effects

• Difficulty falling or staying asleep is a common Actiq side effect

• Uncontrollable shaking of the body, back and chest pain and sudden reddening of the neck, face or upper chest have been observed as Actiq side effects

• Sores, pain or irritation in the mouth where you placed the medication is common when taking the drug

• Swelling of the arms, feet, hands, lower legs and ankles are common Actiq side effects

Certain Actiq side effects are regarded as severe. If you experience any of these symptoms, you must call your doctor immediately:

• Accelerated or slower heart beat

• Seizures, hives and rashes are regarded as severe Actiq side effects

• Excessive itchiness

If you experience any of the following Actiq symptoms, you must stop using the drug immediately or seek emergency medical help:

• Seek medical help you experience slow or shallow breathing

• A decreased urge to breathe requires immediate medical attention

• Dizziness, confusion and/or fainting requires immediate medical attention

• Extreme drowsiness is an Actiq side effect that necessitates medical attention

Other Actiq side effects may present themselves; please call your doctor if you experience any unusual or adverse reactions when using this medication. Additionally, if you experience serious Actiq side effects, you or your medical professional may send a report to the United States Food and Drug Administration’s MedWatch Adverse Event Reporting Program found online at http://www.fda.gov/Safety/MedWatch or via telephone at 1-800-332-1088.


Actiq FDA Regulations:

In July of 2011, The United States Food and Drug Administration instituted the following sentences to the Actiq warning section:

The substitution of Actiq for any other fentanyl product may result in fatal overdose.

•When prescribing, do not convert patients on a mcg per mcg basis to Actiq from other fentanyl products.

•When dispensing, do not substitute an Actiq prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of Actiq compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of Actiq for any other fentanyl product may result in fatal overdose.


Actiq Lawsuits:

Since its approval in 2004, it has been reported that less than 1% of Actiq prescriptions are initiated by Cancer doctors. Various reports allege that more than 80% of Actiq prescriptions are given to patients who do not have cancer. This “off label” epidemic is extremely dangerous and grounds for Actiq lawsuits.

Off-label prescribing is the practice of prescribing a drug for a purpose different than the one(s) listed or approved by the FDA. Off-label prescription is dangerous because it perpetuates the presence of side effects and unforeseen adverse reactions. In addition to off-label use, Actiq is susceptible to abuse and subsequent overdoses.

Cephalon Inc., the manufacturer of Actiq reports that 127 deaths occurred in patients taking Actiq. Additionally, 91 serious, non-fatal injuries have been reported to the FDA. Currently, the U.S. attorney’s office in Philadelphia is investigating the marketing practices attached to Actiq.
In addition to government troubles, Actiq lawsuits have been and are currently being filed by users. Actiq lawsuits may be filed against a number of parties involved in the manufacturing, selling and prescribing of the medication. Actiq lawsuits have been filed against Cephalon over the Actiq lozenge causing tooth decay and against doctors for off-label prescribing.

Actiq lawsuits, therefore, may be filed under an assortment of terms. The two most common Actiq lawsuits are filed against Cephalon for unexpected or severe side effects and against doctors for off-label use. If you feel that you have been victimized from Actiq-use or that you have been negligently prescribed the drug, you should immediately consult with a legal professional to initiate an Actiq lawsuit. If the lawyer (drug, personal injury, medical malpractice or product liability) believes you have a case, he or she will initiate the claim in hopes of securing an Actiq settlement.

Actiq settlements are used to offset the costs associated with developing a medical condition from Actiq use. Anyone injured or mis-prescribed Actiq, should meet with a qualified lawyer to: evaluate their Actiq lawsuit, find out if they have a viable claim against Cephalon and are entitled to Actiq settlements, understand the process of securing an Actiq settlement and decide whether they wish to file an individual Actiq lawsuit or a class action Actiq lawsuit.

Actiq settlements may only be attained by the plaintiff if he or she can definitively prove the link between the illness/condition and Actiq use. For malpractice cases, Actiq settlements are only secured if the plaintiff can affirm the off-label action. In either form, the Actiq settlement is used to offset the costs associated with the medical condition. An Actiq settlement may include compensation for pain and suffering, lost wages due to missed work and medical expenses.

Sources:

1.The United States Food and Drug Administration:

“Safety” Actiq oral transmucosal” retrieved from:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm194045.htm

2. United States National Library of Medicine "Fentanyl" retrieved from:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000326/

3. http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085817.pdf

4. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm194045.htm

5. http://www.fda.gov/downloads/Drugs/DrugSafety/

PostmarketDrugSafetyInformationforPatientsandProviders/UCM264065.pdf