Actiq And Fentura: Opioid Narcotics Used For Migraine/Headache Pain

As you probably know, thousands of persons suffer from migraine/headache pain. Despite concerns raised by many experts, doctors sometimes use opioid narcotics for treatment of such pain. Given the strength of many of these drugs and the potential risk of improper patient selection, improper dosing and mis-use, certain patients may be placed at risk from these drugs. A number of concerns have also been raised about subtle, or sometimes not so subtle, acts by drug companies encouraging doctors to prescribe these drugs for purposes not specifically approved by the FDA.

Actiq is a powerful opioid narcotic that is delivered to the bloodstream by a lollipop lozenge. Anesta, a Utah-based corporation, developed Actiq. The company was purchased by Cephalon in 2000.  Actiq initially had sales in the tens of millions, but as a result of Cephalon’s aggressive marketing, sales rose to over $500 million dollars by 2006.

Actiq was approved by the FDA for the limited use of breakthrough pain in cancer patients who were “opioid tolerant.” Breakthrough Pain (BTP), a component of chronic pain, is a transitory flare of moderate-to-severe pain in patients with otherwise stable persistent pain.  Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least eight mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.

In 2007, a study by Prime Therapeutics reported Actiq had an “off-label” use of 90%. As we have mentioned quite often, off-label use refers to the use of a drug for a treatment other than the specific use approved by the FDA. While doctors are permitted to prescribe a drug for “off-label” use, drug companies are not allowed to promote or market a drug for uses other than those specifically approved by the FDA.

There is no safe dose of Actiq in patients who are not opioid tolerant. Fentanyl, a key ingredient in Actiq, has been linked to fatal respiratory complications.  In fact, Actiq was associated with the deaths of 127 people. The FDA reported another 91 incidents of severe side effects.

The extraordinary “off-label” use of Actiq caused the FDA’s Office of Criminal Investigations and the U.S. Attorney General to undertake an investigation of Cephalon’s marketing practices. From 2001 through at least 2006, Cephalon was alleged to have promoted Actiq for non-cancer patients to use for such maladies as migraines, back pain, and even injuries. The government asserted that Cephalon had trained its sales force to disregard the FDA restrictions in the approved label.

The government’s investigation also found that Cephalon focused marketing efforts on doctors other than oncologists and that Cephalon structured its sales quotas and bonuses in such a way that sales representatives could only reach their goals if they sold the drug for off-label use. Cephalon ultimately pled guilty to a criminal charge for Distribution of Misbranded Drugs and paid a fine of $425 million dollars.

Cephalon purchased Fentora, a new opioid drug, from Cima Labs. The company began marketing Fentora when Actiq became open for generics in the fall of 2006. Fentora, like Actiq, was approved for the very limited use of breakthrough pain in cancer patients. The FDA-approved indication for Fentora was for patients who were being treated around the clock with opioids.  Fentora is reportedly three to four times more powerful than Actiq.

Within months, it was reported that the “off-label” sales of Fentora were very similar to those of Actiq. By early summer 2007, several deaths were associated with Fentora use. These deaths prompted Cephalon in September of 2007 to send a “Dear Doctor” letter reporting that “Serious Adverse Events, including deaths, have occurred in patients treated with Fentora.” Cephalon then blamed the deaths on improper patient selection, improper dosing, and/or improper product substitution.

Our Mass Torts Section is investigating claims where a doctor or hospital prescribed or administered Actiq, Fentora or another opioid narcotic for treatment other than breakthrough pain in cancer patients. If you or a loved one has suffered injury from taking either Actiq or Fentora or if you need additional information, please contact Leigh O’Dell or Alyce Addison at 1-800-898-2034 or by email at Leigh.Odell@BeasleyAllen.com or Alyce.Addison@beasleyallen.com. Lisa Bruner is the primary staff person on these drug cases. She can be reached by email at Lisa.Bruner@bealseyallen.com.

Avandia®

Avandia has been a very popular prescription used to treat patients with Type II diabetes. This drug has been associated with a significant increase in the risk of heart attacks, and an increase in the risk of death from cardiovascular causes.

Lawyers:  Frank Woodson and Roger Smith

Primary Staff Contacts: Cathy Perry and April Worley

Bard Composix Kugel Mesh Hernia Patch®

The Composix Kugel Mesh Hernia Patch, manufactured by Davol, Inc., was first introduced in 2000. The patch is used to repair ventral hernias. In some cases, a hernia can be repaired surgically. However, when the stomach muscles can’t withstand the stitching required, mesh is inserted and placed between the intestines and the stomach muscles to help contain the intestines.

Not long after the patch was introduced to the market, the FDA began to receive reports of problems with the patch. By 2005, the number of reports had greatly increased regarding the recoil ring which could easily break.  When the ring breaks, patients experience bowel perforations and other serious injuries.  The reports prompted the FDA to issue a recall in December 2005 of the Bard Composix Kugel Mesh X-Large Patch.  Doctors were warned to stop using that version of the Kugel Mesh Hernia Patch, and patients with this particular patch were told to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site.  By February 2007, the Kugel Patch recall had been expanded twice to include several other sizes of the device.

Lawyer:  Melissa Prickett

Primary Contact:  Christi Bryant

Chantix®

The Section is investigating claims of death by suicide or attempted suicide resulting in permanent injury involving Chantix. The drug, marketed by Pfizer, is a prescription medication used to treat smoking addiction.

Lawyer:  Frank Woodson

Primary Staff Contact: Cathy Perry

Digitek® (Digoxin)

Digitek is a medication used to treat congestive heart failure, abnormal heart rhythms and other heart conditions. Digitek was recalled due to the possibility that tablets were doubled in thickness and could contain twice the appropriate level of the active ingredient.  There have also been reports of digitalis toxicity leading to death.  The Section is investigating claims on behalf of clients who were taking Digitek and suffered a catastrophic injury or death due to digitalis toxicity.

Lawyer:  Roger Smith

Primary Staff Contact:  Kristy Campbell

Fosamax®

Fosamax®, manufactured by Merck, is in a class of drugs called bisphosphonates.  Fosamax® is commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women.  Fosamax can cause a serious bone disease called osteonecrosis of the Jaw (ONJ).  Osteonecrosis is a disfiguring and disabling condition of the jaw bone that causes infection and rotting of the jaw bone. Typical presentation of osteonecrosis is pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone.  Symptoms may occur spontaneously, or at the site of previous tooth extraction.

Lawyers:  Leigh O’Dell, Chad Cook, and Russ Abney

Primary Staff Contact:  Tabitha Dean

Gadolinium

The FDA has asked manufacturers of all Gadolinium-based contrast agents to include a black boxed warning on the product label. These contrast agents are used to enhance the quality of magnetic resonance imaging (MRI) and can place patients at risk for developing a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). People who develop NSF or NFD may experience a thickening of the skin and other organs, which can limit their ability to move, extend joints and can lead to significant pain and even death. The Section is currently evaluating these Gadolinium-based contrast agents involving patients who have developed nephrogenic systemic fibrosis or Nephrogenic Fibrosing Dermopathy.

Lawyer:  Roger Smith

Primary Staff Contact:  Kristy Campbell

Heparin®

Heparin is a prescription, injectable blood thinner, primarily used for hemodialysis and cardiac invasive procedures. Heparin has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. CDC confirmed growth of Serratia marcescens from several unopened syringes of the product on January 18, 2008.  On January 25, 2008, Baxter Healthcare Corp. announced the voluntary recall of nine lots of heparin sodium injection 1000 units/ml, 10ml and 30ml multi-dose vials.  We are currently investigating claims on behalf of individuals who suffered a severe allergic reaction, catastrophic permanent injury or death due to receiving contaminated heparin.

Lawyer:  Chad Cook

Primary Staff Contact:  Tabitha Dean

Hormone Therapy

For years, women have taken Hormone Therapy (HT) to reduce the symptoms of menopause. Studies now show that HT medications such as Prempro and Premarin can increase the risk of breast cancer, ovarian cancer, stroke and heart disease. We are currently investigating potential claims against the manufacturers of HT medications.

Lawyers: Ted Meadows, Melissa Prickett, Russ Abney, and Navan Ward

Primary Staff Contacts: Katie Tucker, Gwyn Harris, and Janet Pair

IPN Therapy

On November 14, 2007 the FDA announced that Pentec Health recalled 27,000 bags of IPN solution manufactured by the company. The bags were dispensed in prescriptions filled on or before September 21, 2007 and were recalled due to an increased incidence in fungal peritonitis.  The distribution was nationwide.

Symptoms of peritonitis include abdominal pain, fever, change in bowel habits and malaise. As the peritonitis progresses, pain, nausea, vomiting, loss of appetite and hypothermia worsen.  Treatment is antibiotic therapy, surgery, and fluid resuscitation.  As many as 50% of patients with secondary peritonitis die of sepsis. The prognosis depends on the underlying condition of the patient, the rapidity of the diagnosis, and the subsequent treatment given.

Lawyers: Ted Meadows and Russ Abney

Primary Staff Contact: Amy Brown

Oral Sodium Phosphate

Oral Sodium Phosphate is a laxative that is commonly given to patients to cleanse the bowels prior to procedures, such as colonoscopies, endoscopic and radiologic examinations, and surgeries.  The primary product that is used for this is Fleet® Phospho-Soda®.  Fleet® Phospho-Soda® has been associated with severe and potentially fatal cases of renal or kidney failure.  It is helpful if the client has undergone a kidney biopsy to determine the source or cause of the renal failure.   The Section is handling cases involving cases of renal failure or death.

Lawyer:  Roger Smith

Primary Staff Contact:  Kristy Campbell

Paxil®

Paxil® (paroxetine) is an anti-depressant manufactured by GlaxoSmithKline.  Public Health Advisories have been issued for Paxil® regarding an increased risk of heart birth defects, persistent pulmonary hypertension (PPHN), omphalocele (an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel) or craniosynostosis (connections between sutures-skull bones prematurely close during the first year of life, which causes an abnormally-shaped skull) in children born to mothers exposed to Paxil®.

Lawyer:  Chad Cook

Primary Staff Contact:  Tabitha Dean

Pain Pumps

Pain pumps are portable and often disposable pain management devices which continuously administer local anesthetic through a catheter to a surgical wound site for several days following surgery to decrease post-operative pain and assist in earlier rehabilitation.

Recently, the use of pain pumps to administer medication directly into the glenohumeral joint space following shoulder surgery has been linked to a severe condition called Postarthroscopic Glenohumeral Chondrolysis (Chondrolysis), in which the cartilage of the humeral head and the glenoid space of the shoulder process has been destroyed and lost.

Chondrolysis symptoms often start between six weeks and six months following surgery and include increased shoulder pain and stiffness, loss of cartilage, decreased range of motion, loss of shoulder joint space, crepitus in the shoulder and loss of strength.  Patients suffering from Chondrolysis are usually unable to complete their post-surgical physical therapy due to pain.  Whatever the patient’s condition was prior to his or her shoulder surgery, the post-operative diagnosis of Chondrolysis is typically much worse.  Ultimately, complete shoulder replacement surgery could become necessary in order to eliminate the painful and debilitating symptoms of Chondrolysis.

Lawyer:  Frank Woodson

Primary Staff Contact:  Cathy Perry

Permax® and Dostinex®

These drugs are prescribed for the treatment of Parkinson’s disease and other neurological problems such as restless leg syndrome (RLS).  In a study reported in the New England Journal of Medicine, a statistically-significant percentage of those who used these drugs for longer than one year developed the potentially serious complication of valvular heart disease (VHD).  Valvular heart disease is typically diagnosed by a painless and non-invasive test called an echocardiogram that uses sound waves to determine if the valves of the heart are functioning properly.

In many cases, valvular heart disease does not immediately result in symptoms, so if you have taken either of these drugs, we would suggest that you speak to your physician about having such a test, and about the nature of the risks associated with these two drugs.

These two drugs are chemically related to the diet drug “Fen-phen,” which was also associated with development of valvular heart disease and another very rare condition called Primary Pulmonary Hypertension (PPH).

Lawyer:  Navan Ward

Primary Staff Contact:  Janet Pair

Reglan®

Reglan is used to treat gastrointestinal disorders such as heartburn caused by reflux.  The FDA recently required a black box warning linking Reglan and tardive dyskinesia. Symptoms of tardive dyskinesia include involuntary and repetitive movements like tongue thrusting, eye blinking and head jerking as well as involuntary movements of the fingers.  These symptoms are rarely reversible and have no known treatment. Those at increased risk for developing tardive dyskinesia are the elderly, especially older women, and people who have taken the drug for a long period of time.  The FDA has advised physicians to avoid long term use of Reglan and recommends that treatment not exceed three months.

Lawyers:  Chad Cook and Danielle W. Mason

Primary Staff Contact:  Tabitha Dean

Stevens- Johnson Syndrome

Stevens-Johnson syndrome is an immune complex hypersensitivity reaction that can be caused from an infection or immune response to drugs. It affects males and females of all ages. The most severe form of SJS is toxic epidermal necrolysis (TENS).  Most cases of SJS appear in children and young adults under age 30. Females with SJS are twice as likely as males to develop TENS, and have an even higher chance if taking a category of drugs known as NSAIDs, non-steroidal anti-inflammatory drugs.

Lawyer: Frank Woodson

Primary Staff Contact: Cathy Perry

Trasylol

Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass surgery who are at an increased risk for blood loss.  Trasylol was manufacturered by Bayer Pharmaceuticals and was approved by the FDA in 1993.  On February 8, 2006, the FDA issued an advisory warning to doctors of the potential for renal toxicity.  On November 5, 2007, the FDA and Bayer agreed to suspend the sale of Trasylol. The Section is investigating potential Trasylol claims involving death after undergoing a coronary artery bypass procedure or kidney failure requiring dialysis or transplant.

Lawyer: Frank Woodson

Primary Staff Contact: Cathy Perry

Yaz, Yasmine, or Ocella

Yaz is a combination birth control pill containing drospirenone and ethinyl estradiol.   It is marketed not only as a contraceptive, but as a proven treatment for premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms.  Yaz is also marketed as an effective treatment for moderate acne.  Studies indicate, however, that Yaz poses a particular heath hazard because a primary ingredient, drospirenone, is a diuretic, that can cause an increase in potassium levels in the blood and lead to hyperkalemia.  Hyperkalemia causes heart rhythm disturbances that can lead to sudden cardiac death, pulmonary embolism, or strokes.  Diuretics can also cause significant problems with the gallbladder, leading to gallbladder removal.

Lawyers:  Melissa Prickett and Alyce Addison

Primary Staff Contact: Gwyn Harris

Zithromax

Zithromax (azithromycin), manufactured by Pfizer, is a popular antibiotic used most often to treat respiratory infections.  It may also be prescribed to treat skin infections and some sexually transmitted diseases. Zithromax is taken once daily, usually for two to five days.  Zithromax can cause liver damage resulting in death or liver transplant surgery. The symptoms for liver damage may include yellow eyes, abdominal pain, nausea, clay colored stools, and dark urine.  Recent warnings have been added to the label regarding abnormal liver function, jaundice, necrosis, hepatic (liver) failure and death, which have been reported by persons taking this drug.

Lawyers:  Chad Cook and Alyce Addison

Primary Staff Contact:  Tabitha Dean

Other Related Articles

• A Report From Our Firm’s Mass Torts Section
• Our Mass Torts section is looking at a number of drugs and medical devices
• Mass Torts Update: Crestor and Guidant
• Opioid narcotics – Actiq and Fentura – Marketed for off-label use
• Mass Tort Update