Accutane Lawsuit

Recently, a New Jersey judge ruled in favor of a patient who was required to have his colon removed due to side effects of taking the popular prescription acne medication known as Accutane, often called Isotretinoin. This victim was the first of many who have recently brought lawsuits against the makers of the drug and have forced legal and scientific investigations into Accutane and similar acne medications. Many of the victims of the severe side effects of Accutane have developed a disease known as Inflammatory Bowel Disease.

Symptoms of Inflammatory Bowel Disease

Inflammatory Bowel Disease is specific type of chronic disease that manifests itself as painful inflammation and swelling in the intestines. The disease also causes a rise in heat within the intestines making the victim extremely uncomfortable. Because Inflammatory Bowel Disease is a chronic illness, it lasts a long time and many patients never recover from the disease. For this reason, it is important for all people to protect themselves from the disease. Symptoms of Inflammatory Bowel Disease include abdominal or side cramps, diarrhea, urgent bowel movements, high fevers, loss of appetite, and anemia. All of these symptoms can be signs that the victim has been infected with Inflammatory Bowel Disease.

Complications of IBD

Other intestinal complications can arise due to Inflammatory Bowel Disease. These complications can be serious and include an intense bleeding from internal ulcers or sores, a rupturing of the bowel, obstruction within the intestines, and a risk of colon cancer. Because Accutane has been known to cause Inflammatory Bowel Disease, these risks are all associated with the use of Accutane as acne medication. Although it is not known exactly how great the risk is of being diagnosed with Inflammatory Bowel Disease by using Accutane, doctors are certain that numbers are significantly high when looking at the ratio between newly infected patients and the number of them who had taken the prescription drug Accutane.

Side Effects of Accutane

While Accutane is known as a popular and effective way of treating severe conditions of acne, it has also been proven to cause Inflammatory Bowel Disease in many people, along with other side effects. Some common other side effects include ulcerative colitis, Crohn’s Disease, depression, birth defects, allergies, and liver damage. If you or anyone you know has experienced these symptoms as a result of taking the prescription drug Accutane, it is important to contact a physician, as well as Personal injury law firm in Los Angeles.

Inflammatory Bowel Disease is very serious, and many of its causes are not yet known. However, there are extremely strong links between the acne prescription drug Accutane and Inflammatory Bowel Disease. Prevention is always the best form of protection, but due to the relatively recent discoveries of Accutane many people were unaware of the severe side effects.

Accutane is recommended by the American Academy of Dermatology (AAD) as the most effective medication for the treatment of nodular acne, which can leave the sufferer with permanent scarring and disfiguration. The recommended course of medication is a daily dose over a 14 to 20 week period. In most cases, Accutane has been proven to successfully control and resolve acne problems.

Common Side Effects

Accutane, like most medications, has side effects associated with its use. Common side effects include thinning hair and a preclusion to chapped lips, decreased tolerance for contact lens and dry or peeling skin. Patients may also experience mild headaches and sensitivity to sunlight.

Abdominal and Stomach Pain

However, Accutane can cause moderate to severe side effects as well and one of the more prominent side effects is acute abdominal or stomach pain. The Mayo Clinic considers these symptoms, along with severe chest pain, blurry vision, difficulty swallowing and extreme depression, rare. Severe abdominal pain or gastrointestinal distress can sometimes lead to complications. Anyone who suffers from the severe side effects of Accutane is urged to contact their physician or another medical professional immediately.

Serious abdominal pain is a sign of severe adverse reaction to the drug Accutane and may result in further damage to the gastrointestinal tract. It may also be linked to a greater incidence of colon cancer in patients that have taken Accutane.

FDA Response

Guidelines set forth by the federal Food and Drug Administration (FDA) state a manufacturer shall revise labeling when there is reasonable evidence of association of extreme hazard. Through these guidelines, the FDA has issued mandatory revisions to Hoffman-La Roche Pharmaceuticals, Inc., on numerous occasions for their product Accutane. The latest packaging inserts cautions patients that acute pancreatitis has been reported in certain patients. In a few patients, fatal hemorrhagic pancreatitis has been a cause of death.

Warning Signs

Any patient who experiences severe diarrhea, rectal bleeding or abdominal cramping, bloating or pain is urged to stop Accutane immediately and seek medical attention. In some cases, patients have continued to suffer symptoms even after the discontinuation of the medication.

Clinical Hepatitis

Another serious health risk that may or may not be related to the use of Accutane in acne therapy is clinical hepatitis. Elevated liver enzymes have occurred in 15 percent of individuals treated in clinical trials of the acne medication. Elevated enzymes returned to normal when the drug was either decreased or discontinued.

Reporting severe side effects of Accutane is not a requirement of a hospital, clinic or doctor. Adverse side effects must be made on a voluntary basis. Sadly, only one in 100 sufferers report their side effects to their health providers.

Taking Medical Action

If you or a family member experiences any symptoms of pain in the stomach or abdominal area, stop taking Accutane immediately and call your physician. Severe abdominal cramps may accompany such mild conditions as bloating or gas while milder pain may be felt with traumatic, life-threatening conditions.

For any additional information, contact the Crohn’s and Colitis Foundation of America, the American Association of Dermatology and the Mayo Clinic. If you experience any of the adverse effects of Accutane, stop taking the drug immediately and seek professional help. Visit www.bakerlegalteam.com for help.

Many who suffer from Accutane’s side effects are no different from patients who suffer from an overdose of Vitamin A and are considered at risk for the complications of conditions manifested by severe abdominal pain.

Accutane, while known to be effective against severe acne, has been associated with suicide for over a decade. Although the U.S. Food and Drug Administration did not require a “suicide attempt” warning to be listed with the drug until 2000, the French equivalent made this warning mandatory in 1997.

Reported Cases

The most well known suicide case that is associated with Accutane is that of Bart Stupak Jr., son of United States congressman Rep. Bart Stupak. The 17-year-old boy, a varsity high school football player, was not prone to depression, exhibited no signs of suicidal thoughts, yet killed himself by gunshot on the night of his prom.

Since then, over 100 reports of suicide claim to be linked to Accutane, though Congressman Stupak believes the number to be far higher, once stating: “We are up over 100 reports, that’s just what is coming in to us, so I believe there are probably over a thousand cases.”

Signs of Suicidal Thought

With suicide, there is a period of depression that foreshadows the ultimate danger. Signs of depression include loss of appetite, unexplained irritability, unusual fatigue, difficulty concentrating, and just overall sadness. However, Congressman Stupak was quoted: “The average time is 88 days from when you start taking it, and the effect is very sudden… You are doing strange things at 3 a.m. and you are dead at 7 a.m.”, emphasizing that there may be little to no warning.

Off the Market

As of April 2010, Accutane is no longer available for purchase as a new prescription. This is due, not only to reports of suicide, but also reports of major medical issues including birth defects, gastrointestinal disorders, as well as depression.

Those who currently use it or its generic, isotretinoin, are advised to watch for any symptoms of depression, as well as any loss of interest in normal daily activities, or thoughts of hurting themselves or others, and to discontinue use of the drug if there are any signs.

There are many lawsuits currently filed against Roche Pharmaceuticals for failing to disclose the possibility of psychotic side effects, in addition to downplaying the dangers that were known to be associated with the drug. Also if need any help about your estate, Real estate law firm in Montgomery County is here to help.

Accutane has been scrutinized by the Food and Drug Administration for its side effects of damage and inflammation to the gastrointestinal tract both during and after use of the drug. Some patients have first noticed or suffered negative health affects long after their Accutane use has stopped. Symptoms of gastrointestinal damage associated with use of the medication may include:

• Diarrhea
• Stomach or bowel pain
• Swallowing difficulty or pain
• Darkening of urine
• Heartburn
• Rectal bleeding
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• Jaundice

Types of Gastrointestinal Disorders

There are several gastrointestinal ailments directly linked to use of Accutane. These illnesses have been experienced in greater numbers by patients using the prescription for their acne than typically seen in those not using the drug. The diagnoses include:

Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) is noted within Accutane’s medication guide as being associated with use of the prescription, even in users who had no prior medical history of IBD or other intestinal problems. There are two types of IBD, both of which are presently incurable:

Crohn’s Disease

Chron’s disease affects the lining of the digestive tract by causing inflammation and symptoms such as severe abdominal pain, persistent diarrhea, vomiting and weight loss. Although there is no known cure for Chron’s disease, it can be treated. Left untreated, Chron’s disease can be fatal through malnutrition.

Ulcerative Colitis (UC)

Causing chronic inflammation of the digestive tract and ulcers on internal organs such as the intestines and rectal lining, UC is also evidenced by abdominal pain and diarrhea. It is treatable, but incurable at the present time.

Acute Pancreatitis

Acute Pancreatitis (AP), a potentially fatal pancreatic inflammatory disease, has also been linked to use of Accutane through studies. AP can appear suddenly through symptoms such as severe stomach pain, vomiting, nausea, fever and a rapid pulse. Upon first diagnosis, hospitalization is generally necessary because life-threatening problems such as internal bleeding, permanent damage to tissues, kidney failure and serious infections may develop.

Esophagitis and Esophageal Ulceration

The esophagus is vulnerable to side effects possibly caused by use of Accutane, such as dangerous inflammation inflicting painful and difficult swallowing, as well as chest pain.

Legal Consequences

There have been approximately 5,000 personal injury claims against Hoffman-La Roche, Inc. surrounding these health conditions and the varied levels of severity experienced by Accutane patients, ranging from increased frequency of abdominal pain to colon removal and other major, life-altering surgeries.

Lawsuits brought by former Accutane patients against Roche have resulted in financial compensation in many cases. For example, an Alabama man was awarded $2.6 million in May 2007 for his chronic diarrhea and subsequent surgeries derived from prescribed use of the drug. A New Jersey woman was awarded $10.5 million for her case, due to the connection between Accutane use and her development of ulcerative colitis at the age of 14, which later resulted in surgical removal of her colon and subsequent chronic, severe diarrhea.

Accutane, prescribed to treat serious nodular acne, has been linked with the development of several gastrointestinal disorders among these being ulcerative colitis, a type of inflammatory bowel disease or IBD.

What is Ulcerative Colitis?

Ulcerative colitis involves the inflammation of the lining of the digestive tract as well as ulcers primarily located in the large intestine and the rectum. The condition usually leads to severe pain as well as diarrhea and like other IBDs, can become very disabling and even life-threatening. While some individuals experience symptoms of ulcerative colitis years after their exposure to Accutane, some develop the disease almost immediately. Fortunately, although there is not a cure, doctors have been able to uncover several treatments for the disease.

Legal Consequences

Roche Pharmaceuticals, the company which engineered and marketed Accutane, has received approximately 5,000 personal injury claims due to the gastrointestinal disorders which the drug has been known to cause. In one particular case, a woman developed ulcerative colitis and filed a claim against Roche stating that the company did not make the side effects of the drug known. She received $10.5 million from the company but eventually had to have her colon removed due to the disease and continues to battle severe, chronic diarrhea. In another instance, in 2010, a man won a suit for $25.16 million dollars against the company. He had also developed the disease and needed to undergo multiple surgeries, including the removal of his colon. It was again determined that the side effects of the drug were not cited by the company.

Types of Ulcerative Colitis

There are four different classifications of ulcerative colitis, based on where the disease is located in the body. Each subtype of the disease has many of its own symptoms which allow for specific diagnosing. Ulcerative proctotis, which is solely located in the rectum, typically has symptoms such as rectal pain and bleeding. In left-sided colitis, the inflammation of the rectum stretches up the left side into the colon with symptoms being weight loss as well as bleeding and abdominal pain. The third type of ulcerative colitis is pancolitis which affects the colon as a whole. This type usually causes blood-tinged diarrhea, fatigue, weight loss, and abdominal pain as well as night sweats. The last and most dangerous form of the disease is fulminant colitis, which, like pancolitis, affects the entire colon. Fulminant colitis causes extreme distension of the colon which can lead to rupturing thereby releasing toxins into the body. Symptoms of this are usually severe pain and diarrhea as well as occasionally dehydration and weight loss.

Treatment

There are several treatment therapies for ulcerative colitis although, unfortunately, there is yet no known cure. These include anti-inflammatory drugs such as corticosteroids, immune system suppressors such as mercaptopurine, laxatives, iron supplements and in extreme cases, surgery such as proctocolectomy in which the entire colon and rectum are removed.

Dealing with Ulcerative Colitis

If you develop any signs and symptoms of ulcerative colitis or any other gastrointestinal disease after taking Accutane, make sure to contact your doctor for an exam to determine whether you have indeed developed a disease. This is critical as ulcerative colitis, if left untreated, can become life-threatening and eventually fatal. It has been known to lead to the rupturing of the colon as well as hemorrhaging. The disease can also be quite painful due to the inflammation of the tissue and the severe diarrhea that most patients experience.

If you believe that you or a family member who has taken Accutane has developed ulcerative colitis or another form of IBD, please contact PA medical malpractice lawyers as you may want to seek compensation for medical expenses as well as personal injury.

Accutane, also known as isotretinoin, can be helpful in treating cases of severe acne, including cystic acne and similar serious, disfiguring skin conditions. However, the drug has been reported in accusation of causing a number of serious side effects, ranging from birth defects to depression and suicide. A number of people, both patients and researchers, have also reported a link between taking Accutane and developing Crohn’s disease, ulcerative colitis, and similar gastrointestinal disorders. Although Accutane manufacturer Roche Pharmaceuticals no longer distributed the drug within the United States, a number of people continue to experience adverse health conditions in the aftermath of taking the drug.

Risks Associated with Accutane

Accutane has several known side effects. One of the most serious is the drug’s teratogenicity, or ability to cause birth defects. The risk of taking Accutane during pregnancy is so great that female patients are advised to use two methods of birth control simultaneously while they are taking the drug, plus for one month before and after the treatment period. Just one dose of Accutane during pregnancy is sufficient to cause serious birth defects.

Depression and Suicide

Mental health side effects have also been reported with Accutane, including clinical depression and suicidal ideation. Additionally, the drug appears to heighten the progression of muscular dystrophy, possibly by accelerating the rate of cell turnover in skin and muscle tissues.

A growing body of evidence also links Accutane to development of certain gastrointestinal disorders, including Crohn’s disease, ulcerative colitis, and inflammatory bowel disease. These potentially debilitating diseases involve inflammation of one or more part of the digestive system, resulting in formation of lesions in the intestinal wall.

Symptoms of Crohn’s Disease

The internal inflammation and lesions caused by Crohn’s disease and related disorders cause a host of outward symptoms. Typical symptoms include:

• Abdominal pain and cramping
• Discomfort from abdominal bloating
• Diarrhea, which can be either watery or bloody
• Visible blood in bowel movements
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• Vomiting
• Loss of appetite and weight loss

When Crohn’s disease is severe, sufferers might also experience intestinal or anal abscesses or extremely frequent bowel movements — sometimes as many as 20 a day. Systemic symptoms can also occur, such as joint pain or arthritis, malnutrition, growth retardation in children, anemia/fatigue, fever, skin lesions or nodules, and possible eye damage. Some evidence points to an increased risk of cancer in the area of the inflammation.

Accutane Litigation and Crohn’s Disease

Drug manufacturers are required to warn users about the potentially damaging effects of their products. Federal law mandates that drug companies include such warnings on the drug label itself as soon as there is reasonable evidence of a link to any serious side effect. When manufacturers have reasonable evidence but fail to provide the required warning, they may be open to litigation from those harmed by the drug.

In March 2010, a jury in New Jersey awarded a landmark $25 million to a former Accutane user who developed inflammatory bowel disease after taking the drug. Prior to that, Roche Pharmaceuticals had already been ordered to pay out over $30 million in various other lawsuits, several of which involved Crohn’s disease, inflammatory bowel disease, and related gastrointestinal disorders.

The expense associated with Accutane lawsuits is one factor that led to Roche pulling the drug from the U.S. market in 2009. Roche continues to market Accutane outside the U.S., however, and the drug is still available within the U.S. as a generic. Since Crohn’s disease can take several years to progress from vague or intermittent symptoms to a more conspicuous stage of disease, it is likely that new cases of Accutane-related gastrointestinal disorders will continue to come to light during the coming years.

Accutane has been prescribed by doctors since the 1980s to relieve symptoms of chemotherapy and to treat severe acne. Since then, thousands of patients have reported serious, debilitating side effects due to Accutane treatment. Side effects noted by patients commonly include gastrointestinal disorders. The American Journal of Gastroenterology reported the connection in 2006, specifically noting the development of inflammatory bowel disease (IBD).

Because the side effects of Accutane may have been prevented, many patients who have experienced side effects from the treatment have legal options for compensation and damages. So far, over 5,000 personal injury suits have been filed due to the link between Accutane and the development of IBD.

The Food and Drug Administration has repeatedly forced Hoffman-La Roche, the manufacturer of Accutane to change the information included on its labels because of the association of side effects. The most recent of these changes is due to IBD. Many patients report development and symptoms of IBD even after their Accutane treatment has ended. Several early symptoms may be brought on by IBD:

• Severe abdominal pain
• Pain in the joints
• Sudden weight loss
• Loss of appetite
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• Skin conditions
• Rectal bleeding
• Fever

Anyone who takes Accutane and experiences any of these symptoms should immediately discontinue the use of Accutane and report the symptoms to their doctor. If a positive diagnosis is given from the doctor, it is beneficial to consult with an attorney.

What is IBD?

IBD is a group of other, more specific disorders that are characterized by inflammation of the intestines. This inflammation is long-lasting and can develop over and over again, even if it should appear to clear up. Symptoms, at first, may appear to be similar to those of the stomach flu. These symptoms include abdominal cramping, abdominal pain, vomiting, diarrhea, weight loss, intestinal bleeding, and rectal bleeding.

Two diagnosable types of IBD exist. They are ulcerative colitis and Crohn’s disease. Ulcerative colitis often causes ulcers and inflammation in the large intestine. In most cases, it begins in the rectum and works its way up the colon. Crohn’s disease usually affects the small intestine, but can occur in all portions of the digestive tract, including the mouth, stomach, and colon. Ulcers result from Crohn’s disease that may go away without treatment, but they often recur in the same or other spots over and over again.

IBD Diagnosis

After discovering initial symptoms it is necessary to visit a doctor for final diagnosis. The doctor will determine if it is IBD, and then, determine which type it is – Crohn’s disease or ulcerative colitis. This is accomplished through examination of stool and observing the intestines with a colonoscope. A colonoscope is a long, flexible tube with a camera attached to the end. X-rays may also be required.

IBD Treatment

Treatment of IBD begins with a healthy, balanced diet. Exact details of the diet depend on the exact details of the symptoms. It may include cutting down on dairy and fiber. Proper sleep is required in combination with the proper diet. Plenty of rest is called for. Stress management is also a part of most IBD treatment as stress greatly aggravates any gastrointestinal disorders.

In most cases, treatment will involve more than a single doctor. Besides your family doctor, a specialist in gastrointestinal disorders (gastroenterologist) will be required. Severe cases will also require a surgeon.

Anti-inflammatory medications are prescribed to relieve the inflammation caused by IBD. Antibiotics may also be prescribed to prevent or treat infection of the ulcers. Depending on the severity, some treatments will require a trip to the hospital or doctor’s office. More powerful medications, called immunosuppressants, may also be necessary. If these treatments do not work, surgery will be needed.

Although Accutane can treat chemotherapy patients and relieve severe acne, it has been shown to cause severe and debilitating side effects. Lawsuits filed on behalf of patients suffering from the side effects of doctor-prescribed Accutane treatment have yielded high awards and settlements of up to $25.16 million. Over 5,000 lawsuits have been filed over bowel problems alone. The side effects of Accutane range from severe to mild, including:

Ulcerative Colitis

Ulcerative colitis is a chronic medical condition of the gastrointestinal tract. It is a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers. Severe cases of ulcerative colitis have been known to cause severe bleeding, rupture of the colon, shock, and even death. After several outbreaks of inflammation, the intestinal wall and rectum will thicken from scar tissue. This results in severe chronic diarrhea. Attacks are often very painful and physically debilitating.

Some cases of ulcerative colitis require hospitalization and surgery. Many patients must have their colon completely removed, resulting in the lifelong use of a colostomy bag for the collection of digested waste.

Accutane users have reported experiencing ulcerative colitis symptoms immediately, while for others it can take months or years. There are several early symptoms of the disease:

• Abdominal pain
• Audible gastrointestinal disturbances
• Urgency to produce a bowel movement following an inability to do so
• Rectal pain and bleeding
• Fever
• Diarrhea
• Vomiting

Crohn’s Disease

Crohn’s disease is another form of IBD. It generally affects the small intestine, but can develop in any part of the digestive tract, from the mouth to the anus. Symptoms can sometimes be treated with medication, but, if that fails, surgery is required. Surgery usually includes removal of the affected part of the intestine. Crohn’s disease is incurable. Even if an affected section of intestine or bowel is removed, it can recur in another section at a later time. Crohn’s disease has several symptoms:

• Abdominal pain and discomfort, especially in the lower right side
• Severe Diarrhea
• Reduced or loss of appetite
• Bloody stool
• Ulcers
• Painful bowel movements
• Fever
• Fatigue
• Constipation
• Eye inflammation
• Fistulas and draining pus
• Rash
• Liver inflammation
• Arthritis
• Stunted growth

Inflammatory Bowel Disease

IBD refers to one of the two specific types listed above: ulcerative colitis and Crohn’s disease. Over 1 million people in the U.S. suffer from IBD and most of those are from ages 15 to 30. Experiencing any of the following symptoms may be a sign of IBD:

• Abdominal pain
• Arthritis or joint pain
• Fever
• Weight loss
• Rash
• Bloody stools

If several of these symptoms are experienced it is necessary to go to a doctor for a complete professional diagnosis.

Liver Damage/Liver Failure

Several patients who have undergone Accutane treatment have experienced chronic liver damage or even complete liver failure. If enough damage or failure occurs, a liver transplant will be necessary. Liver transplants are extremely expensive and complications can set in unexpectedly. Some early symptoms may be a sign of liver damage:

• Loss of appetite
• Fatigue
• Nausea
• Diarrhea
• Unexpected weight gain or weight loss

More advanced stages of liver damage have more severe symptoms:

• Jaundice
• Abdominal swelling
• Personality changes
• Confusion
• Fluid retention
• Coma

Other Serious Side Effects

Several other serious side effects have been reported from those who have undergone Accutane treatment:

• Suicidal thoughts (often leading to fulfillment)
• Severe depression
• Birth defects in expectant mothers
• Allergic reactions

Additional Side Effects

Accutane users have reported the following mild and medium symptoms

• Severe acne
• Dry skin
• Loss of hair
• Headache
• Eczema
• Brittle nails
• Sensitivity to sunlight
• Menstrual disturbances and disruptions
• Muscle pain