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Generically known as Isotretinoin, Accutane been a popular anti-acne drug since it came on the market in 1982. It went “off patent” in 2002 and has been available in generic prescription form under a variety of names. It was originally intended for the treatment of severe acne but many dermatologists prescribe the drug for off-label purposes.

What is Accutane?

The drug is a form of vitamin A with the generic name isotretinoin. The drug is used in the treatment of cystic acne, or otherwise known as nodular acne, when other treatments have not been successful. Other treatments include benzoyl peroxide or clindamycin applied to the skin, or tetracycline or minocycline taken orally.

Accutane belongs to the class of drugs called retinoids, although the drug was first marketed for chemotherapy. High amounts of facial oil, or sebum, can cause severe acne and permanent scarring, thus the drug works by decreasing the production of facial oil, or sebum.

Hoffmann-LaRoche’s isotretinoin drug was first approved by the U.S. Food and Drug Administration (FDA) back in 1982. Roche discontinued the manufacturing of the medication back in 2009, after several reports of unfavorable events and after doctors noted the possible dangers associated with the drug.

Following the manufacturer’s patent expiration in 2002, many other companies started selling cheaper generic version of isotretinoin including Amnesteen, Claravis, and Sotret. In some countires, Hoffmann-LaRoche is still selling isotretinoin under the name of Roaccutane.

Symptoms and Side Effects

The most common side effects of the medication include weakened night vision, high sensitivity to UV exposure, nose bleeding, peeling skin, bleeding or swollen gums, changes in voice, slow healing of cuts and sores, dry skin and eyes, increased bone injuries (due to thickened or weakened bones), cracked red or sore lips, changes in nails, unnatural hair growth or hair loss, fatigue, headaches, cold symptoms, and muscle aches.

Other reported side effects also include dry eyes, lips and mouth, minor swelling of eyelids or lips, crusty skin, and an upset stomach.

Rare side yet serious side effects include tingling sensations in the skin, quick or severe sunburn, back, joint or muscle pain, pain when swallowing, peeling skin on the palms or soles, signs of infection (e.g. fever, persistent sore throat), and mental or mood changes such as depression, aggressive or violent behavior, and rare cases of thoughts of suicide.

Lawsuits and Litigation

Hoffmann-LaRoche Inc., the manufacturer of Accutane, has been facing thousands of lawsuits from users of the drug due to its adverse side effects.

A New Jersey Accutane user by the name of Kamie Kendall was diagnosed with ulcerative colitis. After going against Roche in court, Kendall won a verdict of $10.5 million in 2008. The verdict was eventually vacated.

Andrew McCarrell, another user of the drug from Atlantic City, New Jersey won a lawsuit against Roche back in 2010. McCarrell needed to undergo five surgeries, including the removal of his colon. Although Roche is currently appealing the decision, Andrew McCarrell was awarded $25.16 million.

Two claimants – Kathleen Rossitto and Riley Wilkinson – who developed bowel diseases in Atlantic City were also awarded $9 million each for damages. Roche is also appealing the verdict’s decisions for this case.

Hoffmann-LaRoche Inc. has been ordered to pay over $53 million to patients adversely affected by the drug so far, although the manufacturer is currently appealing most of the cases’ verdicts.

Bowel diseases are not the only lawsuit cases that have been filed against Roche for the use of their isotretinoin drug. Other plaintiffs include patients and family members of patients who have undergone the side effects from the drug, such as: birth defects, depression, and suicide attempts.

Warnings were slowly and continuously added to the drug information since its release in 1982 until it was discontinued in 2009. As such, some lawsuit cases are dependent on the dates that the medication was prescribed, when health concerns were first diagnosed, and when the warnings were revealed to the public.

Birth Defects

Approximately half of this drug’s users are women that are of age to bear a child, which makes birth defects linked to Accutane a grave concern for users.

It was in 2002 when the generic form of the drug was approved. In the same year, the FDA received reports noting that 172 babies were born with either a congenital defect or an anomaly after the mother had used the drug.

Over 2,000 isotretinoin users became pregnant between 1982 and 2006. This resulted in several “spontaneous or elective abortions.”

In an effort to salvage controversies related to isotretinoin, Hoffmann-LaRoche initiated several programs such as the pregnancy prevention program, the SMART Program, and the iPLEDGE program.

The pregnancy prevention program was issued in 1988, which aims to reduce the number of women getting pregnant while using the drug. The program was successful in its goal, resulting in less than two out of every 1,000 women getting pregnant every year.

The statistics prior to the pregnancy prevention program was reportedly four out of 1,000 women getting pregnant while under the medication of isotretinoin.

Unfortunately, as this number decreased, number of prescriptions sent out also increased. Although the program was intended to educate its childbearing users, it did not eradicate the instances of birth defects related to the use of the drug.

On the other hand, the SMART program required patients to sign consent forms, watch informational videos, take pregnancy tests and use two different kinds of birth control.

Because the SMART programs weren’t effective, the iPLEDGE program was created in 2006. The latter program also required patients to take pregnancy tests at the doctor’s offices, and also included patient registration via computer.

Based on a 2011 study by Kaiser Permanente, California health care patients showed that iPLEDGE was not any more successful than the SMART program. iPLEDGE failed to significantly decrease fetal exposure to Accutane.

The two programs had similar rate of fetal exposure: an average of three exposures for every 1,000 patients. Fetal dangers from the drug exposure can range from miscarriages to babies born with slits on where the ears would supposedly be.

The drug has carried a black box warning in its labels since 1985. The warning included risks of birth defects: “Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount.”

Additionally, the black box warning also enumerated likely birth defects that could result from isotretinoin exposure:

  • Skull abnormalities
  • Facial dysmorphia
  • Eye abnormalities
  • Thymus gland abnormality
  • Parathyroid hormone deficiency
  • Ear abnormalities
  • Cleft palate
  • Central nervous system abnormalities
  • Cardiovascular abnormality
  • Lower IQ

Gastrointestinal Disorders

Gastrointestinal disorders are typically identified through “intermittent symptoms and remission.” What’s alarming about this type of illness, however, is the likelihood of the intestines to become severely damaged after inflammation.

Treatments for gastrointestinal disorders are dependent on the gravity of the symptoms. Patients suffering from gastrointestinal disorders linked to Accutane use have treatments ranging between medications to bowel removal.

Over the years, gastrointestinal disorders linked with taking the drug have continuously grown. Between 1997 and 2002, there were reportedly 85 cases of Inflammatory Bowel Disease (IBD) linked with the use of isotretinoin, although the particular connections were not confirmed.

It was in 1999 when The American Journal of Gastroenterology published a letter to the editor noting that likely association between IBD and isotretinoin.

In the same journal, a published study in 2005 also reviewed 85 cases of IBD. It was found that Accutane could have been the factor that triggered the disease formation. The FDA adverse event database obtained 266 cases of IBD related to isotretinoin use between 2003 to 2011.

The drug has been associated with two types of gastrointestinal disorders: Crohn’s disease and ulcerative colitis. The symptoms for these two disorders manifest in varying ways and can affect various areas of the intestinal tract.

Symptoms for both Crohn’s disease and ulcerative colitis include:

  • Weight loss
  • Abdominal pain
  • Rectal bleeding
  • Malaise
  • Fever
  • Bloody diarrhea

Crohn’s Disease

Crohn’s Disease is an autoimmune disorder – where the body’s immune system attacks healthy body cells and tissues. The disease frequently affects the small bowel and the beginning of the colon, but it can also affect any other area within the gastrointestinal tract.

  • 30 percent of cases encompass the small intestine only
  • 30 percent of cases encompass the large intestine only
  • 40 percent of cases encompass both the small and large intestines

Unfortunately, there is no cure for Crohn’s Disease. However, some people suffering from the illness can experience “asymptomatic periods” in between “flare-ups.”

Those suffering from advanced cases of Crohn’s Disease may also feel pain and bleeding during bowel movements, which can also cause tears in the anus lining.

Abscesses, inflammation of joints, thickening of the intestinal wall, and possible surgery to remove the colon are just some other complications that patients with the illness may experience.

Ulcerative Colitis

Ulcerative colitis (UC) frequently begins at the rectal area before advancing to the colon. Ulcers producing pus or mucous can be a result from an inflamed colon lining.

Approximately half of patients suffering from UC feel some mild symptoms including abdominal pain, blood and pus in stools, diarrhea, fever, rectal pain, and weight loss.

Patients suffering from severe cases of ulcerative colitis frequently require being admitted to the hospital for acute attacks. Repetitive attacks can result in the thickening of the walls of the intestine and rectum from scar tissue, which can ultimately result in infections.

The only cure for ulcerative colitis is to remove the colon. Other complications associated with UC include:

  • Blood clots
  • Colorectal cancer
  • Massive bleeding
  • Tears in the colon
  • Liver Disease
  • Mouth Sores
  • Ulcers

Depression and Suicide

Several users of the drug have also reported side effects of depression and suicidal behavior. There were 190 reports of suicide attempts from Accutane users from 1982 until 2005.

In fact, the FDA received a whopping amount of reports that the drug was one of the top 10 drugs in 2003 that was commonly linked to depression and suicide attempts. Even patients who have used the drug with no psychiatric history have reported side effects of depression.

Some symptoms of depression include:

  • Anxiety
  • Loss of interest in activities
  • Irritability
  • Difficulty concentrating
  • Poor performance at work or school
  • Feelings of worthlessness
  • Hallucinations
  • Crying spells
  • Sadness
  • Changes in appetite
  • Trouble sleeping
  • Withdrawal from friends or family
  • Acting on dangerous thoughts
  • Thoughts about hurting or killing oneself

FDA Recalls, Reports, and Warnings

Just a year after Accutane was released to the public in 1982, a report surfaced regarding a baby born with malformations after the drug was used by the mother during pregnancy.

In 1983, two “Dear Doctor letters” were sent out, informing doctors of the possibility of birth defects. Seven more letters were sent out between 1984 and 1988.

This type of letter is essentially important – they are “special communications” required by the FDA for drug manufacturers to alert physicians of other possible side effects of the drug when the drug label is insufficiently covering information regarding the side effects.

Back in 1983, Dr. Frank Yoder wrote a letter to the American Journal of Medicine. Dr. Yoder is one of the scientists behind the discovery of Accutane, and in his letter alerted the public of likelihood of Hoffmann-LaRoche’s unclear alerts of toxicity linked to the drug.

During the same year, non-profit health advocacy group Public Citizen created a petition for the FDA to add supplementary warnings of birth defects onto the drug’s labels.

It was only in 1985 when the FDA finally issued a black box warning for Accutane. The warning included the statement of the drug’s possibility to cause fetal malformations and even fetal death.

The Centers of Disease Control (CDC) also helped in proving the alleged dangers associated with Hoffmann-LaRoche’s branded isotretinoin. The institution published information regarding the fetal toxicity of the drug based on a study of pregnancies, which were exposed to Accutane.

Furthermore, it was in 1998 when the CDC also sent a letter to the FDA. Stipulated in the letter was a recommendation to ban the drug from being sold because of said danger.

Additionally, the Birth Defects and Developmental Disabilities division of the CDC also obtained several reports of infant deaths following maternal exposure to the drug.

The number of reports of adverse events to FDA continued to grow. This prompted Hoffmann-LaRoche to stop manufacturing Accutane in June 2009. The company argued that the decision to discontinue drug manufacturing was because of economic reasons, stating that generic brands of the same medication were ruling the market. The drug was also recalled in another 11 countries.

Lawsuit funding is NO LONGER AVAILABLE on Accutane