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Accutane Attorney

Fort Smith, Arkansas, Tulsa and Oklahoma City, Oklahoma

What is Accutane? Accutane was developed by Hoffman La Roche in the early 1980s to combat severe nodular acne, which can cause permanent scarring and lesions. While it is very effective in treating acne that does not respond to traditional medicines, dangerous side effects have become apparent, including depression, suicide, heart palpitations, and many more. The FDA has recognized so many risks that they now require the “FDA Medguide for Accutane” be distributed with each prescription and they urge consumers to read the guide each time they take the medication.

• Is liver damage associated with Accutane?
• Are birth defects associated with Accutane?
• Is bone and muscle damage associated with Accutane?
• Are depression and suicidal thoughts associated with Accutane?
• Is bowel damage associated with Accutane?
• Is pancreatic damage associated with Accutane?
• Can Accutane cause vision/hearing problems?
• What other side effects are associated with Accutane?
• What has the FDA said recently about Accutane?

 

Is liver damage associated with Accutane?
Yes. In fact, such damage may be permanent, even if one discontinues the use of Accutane. In a clinical trial of people adversely affected by Accutane, 15% of them had mild to moderate increases of liver enzymes in their systems. Diseases of the liver include Hepatoxicity, Hepatitis, Cirrhosis, and Fatty Liver. Because of the many cases of liver damage associated with the use of Accutane, the FDA has required Hoffman/Roche to include the following warning label on prescriptions of Accutane:

At one time, Accutane was the number one prescription acne medication in the United States. However, Accutane is now considered a defective drug. Accutane has been associated with such side effects as: Clinical hepatitis considered to be possibly or probably related to Accutane therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or [normalized while continuing to take the drug].

Furthermore, the FDA’s guide has this to say about Accutane’s effects on one’s internal organs: Symptoms [of Accutane usage] may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane.

Are birth defects associated with Accutane?
Yes. The FDA warning for Accutane explicitly states that Accutane must not be ingested by pregnant women, no matter how small the dose. In addition, women must not become pregnant for a month after discontinuing the use of Accutane. If you are currently sexually active and plan to ingest Accutane, use two separate forms of birth control during sexual activity, and for one month both before and after the use and discontinuation of Accutane. If you are pregnant, or plan on becoming pregnant, both external and internal abnormalities may afflict the fetus if Accutane is ingested. External abnormalities may include those of the skull, ears, eyes, facial dysmorphia, and cleft palate. Internal abnormalities may include cerebral abnormalities, cerebellar malformation, hyrdrocephalus, microcephaly, cranial nerve deficit, cardiovascular abnormalities, parathyroid hormone deficiencies, and thymus gland abnormalities. In addition, there is an increased risk of spontaneous abortions and premature births. IF YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT, DISONTINUE USE OF ACCUTANE IMMEDIATELY AND SEE A DOCTOR.

For a thorough review of all that the FDA has to say about the use of Accutane and birth defects, please visit http://www.fda.gov/cder/drug/infopage/accutane/smart.pdf.
Is bone and muscle damage associated with Accutane?
Yes. Bone and muscle damage in Accutane users include:

• Spontaneous osteoporosis
• Decrease in bone density
• Bone fractures
• Delay in healing of bone fractures
• Swelling of skeleton bones
• Muscle and related muscle weakness
• Calcifications of tendons and ligaments

 

Cases of bone / muscle damage in Accutane users has become so prevalent that the FDA has required Hoffman/Roche to include the following warning on prescriptions of Accutane:

Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the Accutane population.

Furthermore, The FDA Medguide on Accutane states that:

Accutane may affect bones, muscles and ligaments and cause in your joints or muscles. Tell your prescriber if you develop pain, particularly back or joint pain.

There are reports that some patients have had stunted growth after taking Accutane for acne as directed.
There are also some reports of broken bones or reduced healing of broken bones after taking Accutane for acne as directed.

Are depression and suicidal thoughts associated with Accutane?
Yes. The use of Accutane has been linked to the following psychiatric disorders:

• Suicide, Thoughts of Suicide, and Suicide Attempts
• Depression
• Psychosis
• Aggressive / Violent Behaviors
• Changes in Personality/Mood Swings/Emotional Instability
• Paranoia
• Withdrawal
• Other Abnormal Behaviors

 

Even more alarming, 1,373 cases of adverse psychiatric affects—all related to the use of Accutane--have been disclosed through Congressional hearings.

The following is a statement directly from The FDA Medguide:

"Some patients, while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems. Symptoms of these problems include sad, "anxious" or empty mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating.

Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed."

Is bowel damage associated with Accutane?
Yes. Accutane has been linked to inflammatory bowel disease, which causes the digestive tract to become swollen and besieged by ulcers. The types of diseases associated with these symptoms include Ulcerative Colitis, Rectal Bleeding, and Crohn’s disease. The FDA has required Hoffman/Roche to include the following warning on prescriptions of Accutane:

"Accutane has been associated with inflammatory bowel disease/Ulcerative Colitis/Crohn's Disease/Rectal Bleeding in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped."

Symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your eyes, or dark urine.

Is pancreatic damage associated with Accutane?
Yes. Also known, as Pancreatitis (inflammation of the pancreas), pancreatic damage can result in the following:
Acute Pancreatitis – symptoms include nausea, vomiting, and abdominal pain. A 10% mortality rate is associated with Acute pancreatitis.

Fatal hemorrhagic Pancreatitis – a fatal hemorrhaging of the pancreas.

Weight loss, lack of appetite, elevated triglycerides, and diabetes may also be symptoms of Pancreatitis.

If you experience any of these symptoms, please seek treatment immediately, for they are very severe. If not treated, Pancreatitis can cause cysts, abscesses, and even death.

Because of the frequent case of Pancreatitis in people who consume Accutane, the FDA has required Hoffman/Roche to include the following warning labels on Accutane prescriptions:

"Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported."

Can Accutane cause vision/hearing problems?
Yes. The FDA Medguide states that:

Some people taking Accutane have developed hearing problems. It is possible that hearing loss can be permanent. Stop using Accutane and call your prescriber if your hearing gets worse or if you have ringing in your ears.

Vision problems: While taking Accutane you may develop a sudden inability to see in the dark so driving at night can be dangerous. This condition usually clears up after you stop taking Accutane but it may be permanent. Other serious eye effects can occur. Stop taking Accutane and call your prescriber right away if you have any problems with your vision or dryness of the eyes that is painful or constant."

What other side effects are associated with Accutane?
There are so many side effects associated with the use of Accutane it is not possible to include them all here. However, some of the side effects include:

• Back pain (severe in some cases, especially in children)

 

• Bone abnormalities, including fracture, delayed healing of fractures, osteopenia, osteoporosis, decreased bone mineral density, hyperostosis (excessive bone growth), premature epiphyseal closure (early closing of growth plates)

 

• Cardiovascular injuries, including fibrosis and inflammation of the myocardium, heart palpitations, stroke, tachycardia, transient chest pain, vascular thrombotic disease, calcification of coronary, pulmonary & mesenteric arteries (“hardening of the arteries”)

 

• Eye and vision problems, including color vision disorder, conjunctivitis, and corneal opacities, decreased night vision, eyelid inflammation, optic neuritis, vision impairment, visual disturbances, keratitis (corneal infections), papilledema, photophobia (light sensitivity)

 

• Blood problems including decrease in red or white blood cells, decrease in serum high-density lipoprotein (HDL) levels, elevated CPK levels, elevated platelet counts, elevated sedimentation, elevation of cholesterol, elevation of serum triglycerides, agranulocytosis, anemia, neutropenia

 

• Digestive system problems including esophageal irritation, esophageal ulceration, esophagitis, Inflammatory Bowel Disease, abdominal pain, colitis, ileitis, rectal bleeding, regional ileitis, severe diarrhea, and bleeding & inflammation of the gums

 

• Psychiatric problems, including psychosis, suicidal ideations, suicide, suicide attempts, aggression, depression, emotional instability

 

• Muscle and Joint problems including Rhabdomyolysis, and calcification of ligaments & tendons, Arthritis

 

• Brain and Nervous system disorders including seizures, paresthesias (burning, tingling), and Pseudotumor Cerebri (false brain tumors)

 

• Skin and Hair problems including abnormal wound healing, more severe acne, bruising, hyperpigmentation (patchy darkening of the skin), hypopigmentation (whitening of the skin), increased risk of sunburn, nail dystrophy, paronychia, peeling of palms and soles, photoallergic - photosensitizing reactions, pruritus (itching), pyogenic granuloma (skin growth), rash (including facial erythema, seborrhea & eczema), alopecia (hair loss), and hirsutism (excessive hair)

 

• Ear and hearing problems including tinnitus (ringing in the ears), hearing impairments, and hearing loss

 

• Respiratory problems including bronchospasms, epistaxis (severe nose bleeds), and respiratory infection

 

• Kidney problems including glomerulonephritis, rhabdomyolysis, hyperuricemia, and proteinuria

 

• Liver problems including hepatitis, and hepatotoxicity

 

• Immune system abnormalities including lupus, lymphadenopathy, allergic reactions, allergic vasculitis often with purpura (bruises & red patches), and anaphylactic reactions, disseminated herpes simplex, and other infections

 

What has the FDA said recently about Accutane?
The FDA now has a site completely devoted to its reports and findings on Accutane here:

http://www.fda.gov/cder/drug/infopage/accutane

 

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