Accutane Lawyers and Attorneys

FDA Tracking Rules for Accutane Use

admin — Tue, 03 Aug 2010 06:59:53 +0000

Isotretinoin, also known as Accutane, is a medication used to treat severe acne. It is usually given after all other acne treatments have been used and found to be unsuccessful. It was approved by the U.S. Food and Drug Administration (FDA) in 1982, to treat severe resistant nodular cystic acne, which is a painful, disfiguring form of acne that will not respond to other treatments.

Shortly after the FDA’s approval of Accutane, numerous reports began showing that many patients using Accutane were having side effects and serious complications. The FDA required warning labels to be put on Accutane packaging, along with package inserts, stating potential risks and complications. They also required marketing campaigns to increase the awareness of the potential side effects of the drug. They warned physicians who prescribed the drug to be aware of signs of depression in their patients. Pregnant women were having babies with severe birth defects while on Accutane. FDA scientific advisers declared that stronger restrictions were needed, due to the severity of some of the side effects.

After numerous complaints about the side effects and requests that Accutane to be taken off the market by individuals, non-profit groups, and government officials,, the iPledge program was implemented in the United States by the FDA, in March 2006. IPledge is a mandatory program that required Accutane patients, their doctors, and the pharmacies to register and use a website before the individual could take the medication. Patients were required to read and sign documents acknowledging that they understood the risks and complications associated with the drug. They also had to use the medication under the established guidelines.

The FDA required that women of childbearing age use two forms of birth control while on Accutane. Before they could use the medication, they had to have two negative pregnancy tests. They also had to take a pregnancy test monthly, until they discontinued the use of the drug. Also, the prescribing doctor had to closely monitor the individual for physical and psychological effects, such as depression and psychotic symptoms. In 2009, Accutane was withdrawn from the United States market by its maker.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

The law firm of Goldberg & Osborne is dedicated to helping injured people nationwide and is currently accepting cases for Accutane® victims. For a FREE case evaluation, please call us toll-free at 1-800-THE-EAGLE (1-800-843-3245) or submit a short and simple online case form here.

The History of Accutane

admin — Mon, 02 Aug 2010 12:21:13 +0000

Originally FDA approved in 1982, Accutane was prescribed for patients whose severe acne didn’t respond to traditional treatments. More than 13 million people have been prescribed the drug. As the years passed, many users reportedly suffered severe side effects including, inflammatory bowel disease (IBD), ulcerative colitis, and Crohn’s disease, depression and suicidal thoughts, birth defects, and liver damage.

On December 30, 2005, the U.S. Food and Drug Administration implemented the iPledge progam for Accutane. It was a computer-based risk management program that restricted distribution of isotretinoin, which is found in Accutane. The program was designed to eliminate fetal exposure to isotretinoin because of the high risk of severe birth defects associated with the use of the drug. Patients, physicians, pharmacies, and wholesalers had to register with iPledge in order to take, prescribe, and dispense the drug. Females taking isotretinoin were required to use two forms of birth control and submit to pregnancy tests before starting therapy, during therapy, and after stopping therapy.

In November 2008, a New Jersey jury awarded $13 million to three people claiming Accutane caused them to develop IBD. Earlier that year, $10.5 million was awarded to a woman who reportedly developed ulcerative colitis from using the drug. Two other Accutane users were awarded $2.62 million and $7 million for similar claims. The manufacturer still faces hundreds and hundreds of lawsuits alleging that they failed to sufficiently warn users about possible side effects of Accutane.

In late June 2009, the maker of Accutane removed the acne drug from the United States market.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

Accutane and Inflammatory Bowel Disease

admin — Mon, 02 Aug 2010 06:19:56 +0000

Accutane was a drug manufactured to treat extreme acne. Unfortunately, it has run into a string of problems causing label changes, the most recent of which is its association with inflammatory bowel disease (IBD) in patients who had never shown signs of the disease before taking Accutane IBD still persisted in many after they stopped taking Accutane.

IBD is really a group of diseases represented by a swelling and reddening of the intestines that lingers and returns time and time again. Sufferers have a much higher risk of colon cancer than those without. Symptoms include vomiting, abdominal pain, unexplained weight loss, rectal bleeding and diarrhea. Crohn’s disease is a type of inflammatory bowel disease that causes open sores along the entire length of the intestines. Treatments are available, but surgery is sometimes required in the most severe cases to remove the colon altogether.

There is often a delay between the onset of IBD symptoms and the Accutane ingestion, so patients and doctors alike often fail to make the connection. On top of that, reporting adverse side effects of a drug is completely voluntary. The FDA estimates that only one out of every 100 adverse side effects experienced, is ever reported.

Over a thousand lawsuits have been filed against the manufacturer of Accutane. Many lawsuits claim that the warnings given by the manufacturer did not adequately describe the risks. One New Jersey case recently awarded the plaintiff $25.16 million in damages. The company has lost cases to the tune of $56 million so far, according to “Bloomberg News.”

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

Andrew McCarrell’s Accutane Experience

admin — Sun, 01 Aug 2010 12:18:27 +0000

In an attempt to control his acne, Andrew McCarrell started taking Accutane as prescribed by his doctor from June 1995 through October 1995. A year later, in November 1996, he was diagnosed with Irritable Bowel Syndrome. His symptoms led to the removal of his colon and five other surgeries.

He retained a lawyer to sue the manufacturer of Accutane, for fraud and inadequate warning labels in 2007. The jury awarded him $2.62 million in damages. The manufacturer appealed the decision to the New Jersey Supreme Court and eventually received a new trial.

The case again went to trial a second time The maker of Accutane argued that it wasn’t legally responsible, but a jury disagreed. On February 16, 2010 a New Jersey jury awarded McCarrell $25.16 million. Seven of the nine jurors agreed the manufacturer failed to provide adequate warning. The jury felt the amount of the award was warranted due to the pain, suffering, and medical expenses McCarrell has incurred over the past fifteen years and what he will have to deal with in the future.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

Use of Accutane Leads to Medical Problems and Lawsuits

admin — Sun, 01 Aug 2010 06:17:18 +0000

There have been some compelling studies in the last few years linking use of the acne drug Accutane to the development of some serious and debilitating conditions. While just about all drugs have side effects, the extremely harmful side effects of Accutane have led to a number of successful civil personal injury lawsuits against the makers of Accutane.

Accutane is an especially powerful treatment for severe cases of acne. While acne is certainly an unpleasant condition, it is not a life threatening condition. Accutane, while effective at treating severe acne, has been shown to cause such a high instance of serious and debilitating side effects that it has been the focus of numerous successful civil lawsuits.

Some of these side effects include severe birth defects, depression, suicidal ideation, blurred vision, dizziness, stroke, seizures, various types of bone, joint and muscle pain, and the development of Inflammatory Bowel Disease (IBD). While many of these side effects can be alleviated when the patient stops taking the drug, patients who develop IBD will have it for life.

Because there is no cure for IBD once it develops, there have been many people seeking to find some sort of justice for themselves or their loved ones in a civil courtroom. These Accutane civil trials have had generally favorable outcomes for the plaintiffs because of the significant link that can be demonstrated between taking the drug and developing the disorder.

Also, because living with IBD involves such a dramatic and difficult lifestyle change, the settlements and awards from successful Accutane civil trials have generally taken into account the pain and suffering of the individual as well. A diagnosis of IBD can have a serious psychological impact on a person and the drug company has been found responsible for that impact, as well as for the medical expenses and other losses which have resulted.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

Accutane Drug Description

admin — Sat, 31 Jul 2010 12:56:31 +0000

Though Accutane was removed from the United States market in June 2009, it is still sold under the brand names Amnesteem, Claravis, Sotret, and the generic name Isotretinoin. The medication is prescribed for cases of severe scarring acne after other acne medications and antibiotics fail to produce satisfactory results. Accutane reduces the amount of oil produced by glands allowing the skin to heal and rejuvenate. The medication is a retinoid and related to Vitamin A. Accutane has many reported side effects. It has been linked to bowel problems, including inflammatory bowel disease (IBD), ulcerative colitis , and Crohn’s disease.

Before a patient receives a prescription for the medication, the individual undergoes mandatory extensive education and signs a consent form along with the health care provider, as required by federal law to fulfill the iPLEDGE program.

The medication is prescribed in doses of 0.5 to 1.0mg/kg of body weight. This dose is divided in half and taken twice a day for 15 to 20 weeks.

Accutane has been linked to numerous side effects. For details about those side effects, see the article entitled: “What are the Side Effects of Accutane”.

Accutane is now recognized to interact with numerous medications including:

Alcohol · Metranol
Desogestrel · Minoxycline
Dienogest · Norelgestromin
Dilantin · Norethindrone
Doxycycline · Noryestimate
Drospirenone · Norgestrel
Estradiol Cypionate · Steroids
Estradiol Valerate · St. John’s Wort
Ethinyl Estradiol · Vitamin A
Ethynodiol Diacetate
Etonogestrel
Levonorgestrel
Medioxyprogesterone Acetate

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

Risks Associated with Accutane

admin — Sat, 31 Jul 2010 07:15:56 +0000

The drug Accutane was used to treat severe cases of acne until its removal from the United States market in 2009. While this drug was very effective in treating acne, it was also known to cause quite a few serious and debilitating side effects. In fact, there have been quite a few successful civil lawsuits over the last few years awarding damages for patients who used Accutane and became seriously ill as a result.

Unreasonable Risk

Just about every drug on the market today has side effects associated with it. Most of these are relatively minor and occur in a very small segment of users. Accutane certainly has some side effects that fall into that category. However, too often, the side effects of Accutane were severe and impacted the lives of the people who took it.

Pregnancy Risks

Many medications are not recommended for use during pregnancy but Accutane proved to be particularly harmful to unborn babies. Taking this drug during pregnancy was known to cause severe birth defects and even miscarriage in some instances. Any women of childbearing age were required to take extra precautions against pregnancy before they were able to take the drug.

Accutane and IBD

The most serious and long lasting side effects associated with Accutane have to do with the development of Inflammatory Bowel Disease (IBD) in people who have used the drug. IBD is a chronic condition whose symptoms include recurring or persistent diarrhea, fever, and severe abdominal pain. These symptoms can be brought under control with a combination of medication and proper diet, but there is not cure for this condition.

Both Ulcerative Colitis and Crohn’s Disease are forms of IBD that can be caused by the use of Accutane. The development of these conditions in people who took Accutane has led to multiple successful civil lawsuits against the drug’s manufacturer. In June 2009, the manufacturer of Accutane announced that it notified the FDA of its intent to discontinue the manufacture and distribution of Accutane in the United States.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

What are the Side Effects of Accutane

admin — Fri, 30 Jul 2010 15:15:26 +0000

Accutane is generally used to treat extreme acne cases. In fact, it was originally developed for use in chemotherapy. It carries along with it the possibility of serious side effects, and hence is not recommended for all patients. Since Accutane is taken internally and does not act specifically act at any one location, its effects can be wide ranging.

Accutane, also known as Isotretinoin, is a medication that is used to treat acne. Accutane has many reported side effects. It has been linked to bowel problems, including inflammatory bowel disease (IBD), ulcerative colitis , and Crohn’s disease. In June 2009, the manufacturer of Accutane announced that it notified the FDA of its intent to discontinue the manufacture and distribution of Accutane in the United States.

Accutane has been linked to numerous side effects that include:

Dry, itchy, crusty skin
Drying of the eyes, nasal and oral mucosa
Skin peeling on the palms of the hands and the soles of the feet
Headaches
Sensitivity to sunlight
Upset stomach
Hair thinning and loss

More serious adverse effects include:

Inflammatory Bowel Disease

Crohn’s Disease

Ulcerative Colitis

Burning, itching, redness of the eyes or visual disturbances
Blood clots
Bone and joint pain
Blood cell damage
Elevated blood sugar
Elevated blood cholesterol
Impaired mobility
Nosebleeds
Burning, redness, scaling and pain in the lip area
Skin rashes or infections
Severe abdominal pain or nausea and vomiting
Back pain or any pain or tenderness in muscles
Behavioral changes including depression, anger, aggression, violence, suicidal thoughts or actions
Bleeding from the mouth or other body cavity
Severe headaches
Severe diarrhea
Yellowing of the skin or the whites of the eyes (liver malfunction)
Pinpoint red dots on the skin especially on the abdominal area
Abnormal fatigue
Feeling faint or fainting
Chest pain
Stroke or heart attack
Irregular, racing or pounding heart rate
Difficulty breathing

Signs or symptoms of infection

Though some of these side effects disappear upon cessation, Accutane’s side effects also may be permanent or long term. If you have taken Accutane and are suffering any of these symptoms, you should consult with your physician immediately.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

Verdict in Excess of $25 Million Awarded for Accutane Injuries

admin — Fri, 30 Jul 2010 07:14:51 +0000

Nearly everyone experiences the embarrassment of acne during adolescence. However, most acne cases are mild and respond well to over-the-counter medications. Unfortunately, many people still suffer from severe acne into early adulthood. The last resort treatment for this type of acne has often been an oral prescription known as Accutane or Isotretinoin.

Accutane has been linked to bowel problems, including inflammatory bowel disease (IBD), ulcerative colitis, and Crohn’s disease. Other possible risks associated with Accutane include: nose bleeds, hair loss, headaches, muscle pain, joint pain, vision problems, and a whole host of other systemic side effects. In extremely rare cases Accutane side effects may even be life-threatening. Accutane can cause a rapid increase in cholesterol levels, a rapid decrease in white blood cell count, and reduced blood flow throughout the body.

The manufacturer of Accutane has faced over 1,000 lawsuits for the long-term adverse health effects of Accutane. In February of 2010, Accutane’s manufacturer lost a substantial lawsuit, resulting in a $25.6 million dollar verdict to Andrew McCarrell of Birmingham, Alabama. McCarrell received Accutane treatments in his 20s only to later develop inflammatory bowel syndrome, a risk associated with Accutane. McCarrell’s case of inflammatory bowel was so severe that his colon had to be surgically removed.

The manufacturer of Accutane has had other verdicts issued against it in favor of Accutane users suffering from inflammatory bowel syndrome. Of the six court cases that have resulted in a verdict, the Accutane manufacturer has lost every time.
In July of 2009, Accutane was withdrawn from the United States market by its manufacturer, stating that competition from generic manufacturers had driven down sales.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.

Statistics About Accutane

admin — Thu, 29 Jul 2010 11:14:21 +0000

Accutane, a drug used to treat severe acne, was taken off the United States market by the manufacturer in 2009. The company claimed that its decision to discontinue production of Accutane was a purely business decision resulting from a shrinking share of the market since the release of generic alternatives. However, some of the severe side effects of Accutane have led to numerous lawsuits being brought against the drug manufacturer.

A Few Numbers

Since Accutane first appeared on the market in the United States in 1982, it has been prescribed to millions of people. This translated into an income of roughly $1.2 billion annually for for its maker. The popularity of this drug was due in large part to its estimated success rate of almost 85%, although in about 20% of cases, acne returned once patients stopped taking the drug.

Adverse Effects

Just about every medication available today has at least some side effects associated with it. The side effects for Accutane, however, can be quite severe and have led to the filing of more than one thousand lawsuits . The successful lawsuits have led to the awarding of over $33 million in damages to the plaintiffs.

The lawsuits center primarily on the development of Inflammatory Bowel Disease (IBD) in patents who took Accutane. IBD, which includes both Ulcerative Colitis and Crohn’s Disease, is a chronic condition that forces sufferers to make significant changes in their lifestyle. The symptoms of IBD can include severe abdominal pain, persistent or recurring diarrhea, fever, weight loss, bone or joint pain, and loss of appetite.

There have also been lawsuits due to some of the psychological side effects and birth defects associated with Accutane use. The drug has been shown to cause a very high rate of birth defects and even caused miscarriage in some cases. A significant number of Accutane users also developed serious psychological issues including depression and suicidal ideation.

Do you believe you or a loved one has been injured by Accutane®? Goldberg & Osborne can help.