Thursday, September, 9, 2010

Accutane News

Accutane Lawsuits Continue to Mount Over Side Effects, Bowel Disease

The prescription medication Accutane – also known in generic forms as Isotretinoin, Sotret and Raccutane – has previously been prescribed to treat severe recalcitrant acne. Introduced in 1982 by Hoffman-LaRoche, Accutane has been used to treat over 13 million people afflicted with acne since its introduction.

While effective in treating the skin condition, Accutane is also known for causing a list of side effects which include, but are not limited to: depression, joint pain, birth defects and miscarriages, heart attacks, strokes, seizures, and inflammatory bowel disease. Because of this list of side effects, the FDA has previously required the medication to bear a black box warning on containers.

The side effects of Accutane have been known for some time now, but despite Hoffman-LaRoche terminating production of the drug in 2009, it continues to be manufactured and distributed by other pharmaceutical companies under various names. Health care providers continue to prescribe the drug despite its list of side effects and can be held accountable and responsible should they fail to inform adequately the risks involved with taking Isotretinoin.

Millions of patients have taken this drug to combat acne, though there is some speculation that it has been, perhaps, over-prescribed to patients whose conditions did not merit its use. It has been found that many patients' symptoms were not severe enough to require its use.

One of the more recent findings concerning the drug and its side effects is that people who have or had used the drug recently are four times more likely to suffer from gastrointestinal inflammatory disorders including ulcerative colitis and Crohn's disease. There has been no evidence suggesting a link between severe acne and these disorders, thus leaving the drug as the primary link in the findings.

Because of the link established between Isotretinoin and its side effects, many lawsuits have been brought against the manufacturers and medical care providers. Because Hoffman-La Roche has been found to be diligent in following the warning guidelines set forth by the FDA, few of the recent cases against them have been successful, however those who suffered the side effects prior to the required FDA warnings have had success in their cases. Cases against health care providers have a much greater success rate since it is the provider's responsibility to warn patients of all the risks they face before taking the medication.

Recent Study Draws Link Between Accutane and Bowel Disease

Accutane is a prescription medication that has been used to reduce severe acne and had been prescribed to patients in the U.S. prior to 2009. The drug works by inhibiting skin pores and glands from performing functions that commonly inflame acne and acne-like skin conditions. In 2009, however, the manufacturer of Accutane (Hoffman-LaRoche) stopped making and distributing the drug after researchers linked Accutane to inflammatory bowel disease and other adverse side effects leading to severe infection and even death.

Accutane has been a common prescription medication used by health care professionals for severe acne since 1980. Between 1980 and 2009, Accutane's popularity grew enormously and even led to prescriptions being written for simple cases of acne. Even though Accutane was never meant to be used for simple acne, doctors were constantly prescribing it. The large influx of Accutane prescriptions meant many more related side effects were being discovered. As a result of Accutane side effects, patients began experiencing serious side effects in much larger amounts than ever before witnessed.

As a result of Accutane, countless patients have experienced inflammatory bowel disease. Researchers at the University of North Carolina-Chapel Hill have proven a clear link between Accutane and ulcerative colitis, which is a form of inflammatory bowel disease. Patients who used Accutane were found to be at least four times more likely to develop ulcerative colitis than nonusers of Accutane, which provides the strong empirical link. Even more significant is the rise in likelihood of developing ulcerative colitis in relation to a higher dosage of Accutane prescribed to the patient. Patients with much higher doses of Accutane see exponentially higher risk levels for the disease. Researchers say this link is nearly indisputable as being caused by the use and prescription of Accutane.

LaRoche has been targeted by more than 1,000 lawsuits related to Accutane and the drug's side effects. Even though LaRoche has discontinued the use and prescription of Accutane, past users of the drug are still dealing with the side effects. Patients suffering from Accutane use are encouraged to contact a lawyer.

In addition to Accutane's connection to inflammatory bowel disease, the drug has also been linked to death as a result of skin infections. Two deaths from skin infections thus far have been reported to be connected to Accutane. Courts have found in favor of plaintiffs alleging skin infection related to Accutane in the past. To date, approximately 56 million dollars in damages have been paid out in settlements to prescribed users.

Settlement Awarded Over Accutane User’s Bowel Disease

Accutane user Jason Peipert had initially sued his doctor, Dr. Daniel Goran, for medical malpractice and settled recently for an undisclosed amount. Peipert, like other plaintiffs with similar complaints, was prescribed Accutane in the 1990s and claimed that he developed inflammatory bowel disease as a result. The condition led to Peipert’s several surgeries, and he suffered great pain through the initial diagnosis and subsequent treatment. In his lawsuit, he contended that it was the use of Accutane that lead to his emotional and physical suffering.

Accutane was first marketed in the 1990s as a treatment for severe acne cases, but has been proven to cause traumatic and chronic ailments as a side effect of the drug’s use. Patients have reported abdominal afflictions, including ulcerative colitis, gastrointestinal disorders, inflammatory bowel diseases and other ailments of the abdomen and gastrointestinal tracts.

In total, six lawsuits have been settled for a combined $56 million against Hoffman-La Roche. Many of the doctors have been sued by their patients in addition to the suit against Accutane’s manufacturer. However, there are hundreds of cases of Accutane users suffering from abdominal problems that have yet to make their way through the courts.

Roche Laboratories, the subsidiary of Hoffman-La Roche – the company that actually produces the drug – pulled its total inventory from the market in June 2009. Nevertheless, the drug company continues to manufacture the drug under the names Amnesteem, Claravis and Sotr. It is no longer available or sold in the U.S.

Earlier this year, another Accutane case was settled when Andy McCarrell was awarded $25.16 million by a jury for pain and suffering. His story closely mirrors Piepert’s. He battled the onset of ulcerative colitis within one year of his last dose of Accutane. His condition led to extreme complications and he finally had to have his colon removed.

All six plaintiffs against the makers of Accutane have won their cases and have been awarded $56 million dollars in compensation. In each of the cases, juries made the determination that it was the fault of the manufacturer for not properly warning doctors about the side effects of Accutane. Only one of the cases has been overturned on appeal.

Hoffman-La Roche was aware of the dangers, especially to women of childbearing age. It was disclosed that the use of Accutane could cause serious birth defects. Even women who had taken preventative birth measures – such as tubal ligation – were advised to take birth control pills because the danger was so great.

Accutane is an acne-fighting medication and is a form of Vitamin A. Vitamin A is used to reduce the amount of oils secreted by oil glands in the skin as well as speeding the process of skin renewal dramatically. It was to be used only when all other acne preparations and medications had been exhausted.