Accutane and Rectal Bleeding

Accutane, also known by the generic name Isotretinoin, is a medication generally prescribed to reduce or fully exterminate acne. Isotretinoin is a derivative of vitamin A (classifying it as a retinoid) which is found to decrease production of sebum, an oily and waxy substance made up of the remnants of dead cells that, at one time, produced fat. This means sebum is mostly made up of fat, dead skin cells, or bacteria, which causes acne to develop on skin surfaces. Sebum has also been found to cause oily hair and increased quantities of earwax. Reducing sebum production has been successful in the attempt to thwart acne, however, the amount required is referred to as a “toxic” dose of vitamin A and results in some severe side effects.

Manufacturer Liability

Several grievances have been filed regarding complications of health, resulting in a large number of changes made over time to the warning label on the medication. As per federal law the producer of a prescription drug is required to reflect any serious and proven risks to one’s health as a result of being prescribed to their product. Accutane’s manufacturers, Hoffman-La Roche, have now been required to list on Accutane’s warning label the risk of inflammatory bowel disease in patients who previously had no history of intestinal disorders.

IBD and Rectal Bleeding

Inflammatory bowel disease can cause abdominal pain, severe diarrhea, and rectal bleeding. Rectal bleeding (medical name: hematochezia) is a severe symptom of several potential health complications and a well documented sign of the early stages of rectal cancer, therefore the occurrence of rectal bleeding is of particular concern to most individuals.

Causes of Rectal Bleeding

Many conditions can result in rectal bleeding. The conditions most often found to be the cause include inflammatory bowel syndrome, anal fissures, hemorrhoids, colon or rectal cancer, diverticulosis, ulcerative colitis, ulcerative proctitis, Crohn’s colitis, infectious colitis, ischemic colitis, and Meckel’s diverticula. Rectal bleeding varies in severity and amount of blood loss, and some of the more serious cases result in heavy amounts of blood loss which leads to fatigue, dizziness, low blood pressure, shock, and occasionally a severe drop in blood pressure when moving from sitting to standing positions known as orthostatic hypotension. Rectal bleeding in any stage of severity has also been documented to cause severe stomach pains and painful bowel movements.

FDA Regulations and Requirements

Federal law indicates that reporting side effects from prescription medication is on a voluntary basis. The high quantity of reports indicating inflammatory bowel syndrome resulted in the warning label classification, and are seen as a clear indicator of the tie between Accutane and rectal bleeding. It has been advised through many outlets to discontinue use of Accutane at the first sign of abdominal discomfort, severe diarrhea or rectal bleeding, and it is also frequently noted that there is a serious possibility of legal recourse as a result of these symptoms. Federal way injury lawyer can give you the information you need and advocacy you deserve.

Accutane and Liver Failure

Accutane is a prescription medication often reserved for the most severe cases of acne, but the troubling side effects have recently been proven to be very detrimental to the health of the patients relying on the medicine. The possibility of liver failure is a primary concern of individuals that have been taking the medication for a lengthy period of time. Patients that are currently using Accutane or have previously used the medication need to be aware of the potential warning signs of liver failure.

Cirrhosis of the Liver

Many medications have been proven to cause some type of liver damage, and the result is the buildup of scar tissue on the inner linings of the organ. Cirrhosis of the liver occurs when the scar tissue that is being built up gradually replaces the healthy tissue. The liver has an important role within the human body and serves as a filter to all foreign materials and substances. Even normal nutrients and mild toxins can prove to be deadly if they are not adequately filtered by the liver, so repeated damage often leads to liver failure. Cirrhosis can also be associated with serious illnesses such as Hepatitis, so it is necessary to consider the warning signs in order to detect a possible cause of the damage to the liver as quickly as able.

Symptoms of Liver Damage

Some of the warning signs of liver damage can include nausea, vomiting, sudden weight loss, rapid weight gain, dehydration, changes in appetite, and diarrhea. Many patients don’t seek medical treatment in time because they mistake the symptoms that they are experiencing for a mild illness or flu. By the time a patient seeks medical attention, the damage to the liver may already be severe enough to lead to liver failure. Some patients are not concerned with the early warning signs because their physician has advised them that Accutane itself can cause nausea. Several indicators of impending liver failure are more severe and may not manifest themselves until a significant amount of damage has already been done. These signs include severe swelling or retention of fluids, jaundicing, changes in mental status or confusion, and abdominal problems.

Dealing with Liver Failure

Once liver failure occurs, it cannot be treated or reversed and the only acceptable way to remedy such permanent damage is for the patient to receive an organ transplant. If liver damage is detected prior to complete liver failure, patients have a much stronger prognosis and can often be treated. Patients currently on Accutane should have frequent blood work processed to check for increased liver enzyme levels. Patients that have taken Accutane in the past should also have a comprehensive metabolic panel completed to rule out any possible liver damage.

Legal Consequences

Multiple lawsuits have already been filed by Wrongful death lawyer in Newport Beach against Roche Pharmaceuticals, who are the creators and manufacturers of Accutane. Because the serious side effects and detriments are not limited to liver failure, patients need to be aware that the medication can also cause other illnesses and conditions such as Crohn’s disease, colitis, severe depression, suicide, and others.

Accutane and Colon Removal

Accutane is a prescription medication that is utilized in the treatment of acne, primarily in adolescent patients. It is usually prescribed when an acne condition does respond to other medications or antibiotics. The brand names for Accutane include: Accutane, Amnesteem, Sotret, and Claravis. New Jersey-based Hoffman-La Roche Inc. is the drug’s manufacturer. This medication is a form of vitamin A and causes a reduction in the amount of oil that a patient’s glands release. This causes the skin to renew itself in a rapid fashion.

Accutane Side Effects

Accutane has been scrutinized by the Federal Food and Drug Administration (FDA) for its numerous side effects. These side effects range from mild to severe. Some of the side effects associated with this medication are pain in the bowels, chest, or stomach. The pain may be an indication that there is damage to the body’s organs that may not dissipate, even though the medication has been discontinued. Additional symptoms that may be a sign of abdominal issues are swallowing that has become difficult or painful, heartburn that has developed or increased, and diarrhea. Other symptoms include bleeding from the rectum, darker urine, and the skin or eyes take on a yellow color.
Just one dose of Accutane can lead to severe birth defects. It can have an effect on the baby’s heart, brain, eye, ears, and numerous other areas of their body.

Psychological Side Effects

There are also neurological and psychiatric issues that are linked to Accutane. Some of the Neurological effects are dizziness, stroke, headaches, lethargy, and insomnia. Psychiatric side effects may include suicide, suicidal thoughts or attempts, depression, and psychosis.

Ulcerative Colitis

The drug has been linked to various chronic conditions that involve damaging effects on the gastrointestinal tract. One of these conditions is ulcerative colitis. Someone with ulcerative colitis, has chronic inflammation in their digestive tract, and ulcers are present on the lining of their large intestine and their rectum. Some users reported immediate symptoms and others developed the conditions months or years after using the drug.

There are complications that can occur in severe cases of ulcerative colitis that include shock, a colon that ruptures, and heavy bleeding. If is possible for death to occur if it is spread through the whole colon. Experiencing repeated inflammation attacks can lead to scar tissue on the rectum and the intestine wall may thicken.

Colon Removal

The majority of ulcerative colitis cases that are in advanced form, require expensive surgical procedures and extended stays in the hospital. It could require that all of the colon and the rectum be removed. After removal, some patients might be required to have an ileoostomy. In this procedure, an opening is surgically made on the wall of the abdomen. The bowels can then remove intestinal waste into an ostomy pouch that collects it.

Symptoms of Ulcerative Colitis

Some symptoms of ulcerative colitis are pain or gurgling noise in the abdomen and difficulty with bowel movements, even though the urge is felt. Other symptoms are fever, rectal pain or bleeding, loss of weight, vomiting, and diarrhea.

Accutane Lawsuits

Hoffman-La Roche Inc. has had hundreds of lawsuits filed against them alleging that Accutane usage has led to conditions such as Irritable Bowel Disease (IBD), and other related issues. In 2008, a woman was awarded 10.5 million dollars because the company failed to give warnings of chronic and dangerous side effects. At 14, she developed ulcerative colitis and her colon was taken out. She now suffers with chronic diarrhea. In another case in 2010, a gentleman received a settlement of 25.16 million dollars from the company because they failed to warn of the bowel disease risks associated with Accutane. He endured 5 operations and his colon was removed.

Many conditions can be attributed to Accutane, but colon removal is the most severe. It causes extreme pain and a debilitating lifestyle. After many procedures, symptoms may persist for a lifetime.

Accutane and Colon Cancer

Accutane is a prescription medication commonly prescribed for patients who have a serious or stubborn acne condition, considered moderate to severe by the consulting physician. It is usually not the first line of action, but is tried after the acne has shown to be resistant to other treatments. Although there are generic forms of the drug, there is no over-the-counter version. It must be obtained by a prescription from a physician, and must be taken in the prescribed dosage. The drug works by reducing sebaceous glands, thus slowing production of oil production, by reducing inflammation, by killing bacteria deep in the skin tissues, and by decreasing the cell build-up that causes blackheads and whiteheads. The benefits are long-lasting, but not permanent. Accutane is a treatment, not a cure.

Accutane Side Effects

One reason that Accutane is not the first drug of choice is because it does have several serious side effects. One very grave side effect of Accutane is the possibility of birth defects, so it should never be prescribed for, or taken by, a pregnant woman. Other side effects include hair thinning and loss, severe skin dryness and thinning, eczema, brittle nails, fatigue, muscle pain, headache, menstrual problems, increased sensitivity to sunlight, gastrointestinal problems, and skin infections and conditions such as impetigo. The gastrointestinal problems include diarrhea, rectal bleeding and inflammatory bowel disease.

Inflammatory Bowel Disease

There are many instances of Accutane patients developing inflammatory bowel disease, even among those who have had no prior history of intestinal disorders. Even after Accutane treatment has been discontinued, the symptoms persist in many patients. Any Accutane patient who experiences rectal bleeding, abdominal pain, or severe diarrhea should stop taking the drug immediately and contact his/her physician. IBD is a serious condition in itself, but has also been shown to have a high correlation with incidences of colon cancer.

Causes of Colon Cancer

Accutane has been shown to cause IBD, and IBD can lead to colon cancer. People with this inflammatory bowel disease have a much higher risk of colon cancer than those in the general population. Although there are many causes of rectal bleeding, this link between Accutane and colon cancer makes it imperative that any patient with a history of taking Accutane and having rectal bleeding needs to be proactive and get checked by their doctor.

Symptoms of Colon Cancer

Colon cancer causes rectal bleeding due to the polyps which form on the interior surface of the colon. Polyps start out as small benign growths. However, when they have grown larger in size, they can bleed. Many polyps remain benign, but other types turn into cancer. When diagnosed early, colon cancer is easily treatable, and usually curable. Surgical removal of the polyps is the main treatment at this stage.

As the cancer progresses, cells can invade adjacent body tissues. They can also break off and migrate to other parts of the body such as the liver and the lungs, causing polyps and tumors there also. At this stage, colon cancer is usually treated with radiation and chemotherapy as well as surgery, and is less curable.

Although colon cancer is more common in people over 50 years of age, it does occur in younger people also. Since those who use Accutane are primarily young people, this link could affect the numbers of people under thirty who develop colon cancer.

Accutane and Bowel Disease

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 and Abdominal Pain

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 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 and Suicide

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 and Gastrointestinal Disorder

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 and Ulcerative Colitis

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.


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 and Crohn’s Disease

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.