Yourlawyer.com (Inflammatory Bowel Disease News)

Accutane Maker Roche AG Ordered to Pay $2.62 Million to Patient Who Developed Inflammatory Bowel Syndrome After Using Drug

Wed, 13 Jun 2007 00:00:00 -0700

A New Jersey jury has awarded $2.62 million in damages to a patient who needed to have his colon removed after taking the drug Accutane. The case was the first of more than 400 suits pending against Roche Holdings AG, the manufacturer of Accutane acne medication. The verdict, issued on May 29, could be ominous news for Roche, as many legal analysts believe it portends more findings against the company.

Andrew McCarrell, the plaintiff in the case, developed Inflammatory Bowel Disease (IBD) after taking Accutane for four months in 1995. In addition to having his colon removed, McCarrel also had most of his rectum removed and had to wear a colostomy bag for years. He recently had surgery that rid him of the colostomy bag, but the 36-year-old software manager testified that he still suffers from severe, chronic diarrhea.

The jury agreed with McCarrell’s lawyers that the Accutane label did not provide sufficient warning about the drug’s IBD risk. In addition to the $2.62 million, the jury also awarded McCarrel $119,000 to cover medical expenses.

Introduced in 1982, Accutane has been the subject of controversy for years. In addition to IBD, the drug has been associated with myriad other serious side effects. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to 266 cases of suicide in the United States. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.

A 2004 USA Today article reported that, in the mid-1990s, contrary to advice from its own doctors, Roche executives chose not to issue stronger warnings about Accutane’s depression risks. According to the article, Roche decided against the warnings after its marketing department expressed concern that doing so would hurt sales. At the time, Accutane was one of Roche’s top-selling medications, bringing in more than $1.2 million every year.

In 1997, in the face of mounting evidence, the FDA finally required Roche to include a suicide warning on the Accutane package insert. Then in 2006, the FDA began the iPledge registry program. This program requires patients to sign a document informing them of the drug’s risks. Patients must also agree not to share their medication with anyone else, and to make follow up visits with their doctors. The program has special requirements for women of childbearing age, including the requirement that they submit to regular pregnancy tests at their doctor’s office. The prescribing physician is then required to enter the results of the tests into the iPledge database. Women also must to sign a pledge that they would use birth control while taking Accutane. Despite these precautions, many consumer advocacy organizations have called for Accutane to be removed from the market, contending that its risks far outweigh its benefits.

FDA Updates Zelnorm Labeling A Treatment of Women With Irritable Bowel Syndrome

Fri, 30 Apr 2004 00:00:00 -0700

The Food and Drug Administration (FDA) today announced the addition of new risk information to the health professional labeling for Zelnorm (tegaserod maleate). Zelnorm is a prescription medication for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. The labeling is being revised to ensure health professionals and patients have the most current and complete information available when prescribing and taking Zelnorm.

The specific revisions include:

    * a new warning about the serious consequences of diarrhea associated with the medication;
    * a new precaution about ischemic colitis and other forms of intestinal ischemia (i.e., reduced blood flow to the intestines);
    * changes to the adverse reactions section describing post-marketing reports; and
    * new information in the "Information for the Patient" leaflet.

The new warning states, "Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea."

The new precaution on ischemic colitis states, "Ischemic colitis, and other forms of intestinal ischemia, have been reported in patients receiving Zelnorm during marketed use of the drug. A causal relationship between Zelnorm use and these events has not been established. Placebo-controlled clinical trials of 7,000 patients for 3-month duration showed no cases of these events, and would suggest the rate of these events is low. Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis."

Under the post marketing experience heading in the adverse reactions section, the labeling now states, "Voluntary reports of adverse events occurring with the use of Zelnorm include the following: ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope, suspected sphincter of Oddi spasm, bile duct stone, and cholecystitis with elevated transaminases. Because these cases are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. No causal relationship between these events and Zelnorm use has been established. Hypokalemia secondary to diarrhea has also been reported."

The new patient information advises patients who get new or increased stomach pain or blood in their stools to stop taking Zelnorm right away and to immediately contact their doctor to determine if they may have a serious problem. In addition, the new labeling advises patients to stop taking Zelnorm and to call a doctor right away if they experience diarrhea that leads to lightheadedness, dizziness or fainting.

FDA approved Zelnorm on July 24, 2002, following the recommendation for approval made by FDA's Gastrointestinal Drugs Advisory Committee on June 26, 2000 (see http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01160.html). Zelnorm is the only FDA-approved prescription drug for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.

Zelnorm increases the movement of stools (fecal matter) through the bowels. Zelnorm does not cure IBS, nor does it treat diarrhea-predominant IBS. Zelnorm reduces pain and discomfort in the abdominal area, and reduces bloating and constipation. The safety and effectiveness of Zelnorm in men have not been established.

In conjunction with today's FDA announcement, the manufacturer of Zelnorm, Novartis Pharmaceuticals Corporation of East Hanover, N.J., has issued a letter to health professionals to highlight the labeling changes.

Accutane Inflammatory Bowel Disease Side Effects

Fri, 30 Apr 2004 00:00:00 -0700

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) refers to particular chronic diseases that cause inflammation, in the form of painful swelling, generally with heat of the intestines. Crohn's disease and ulcerative colitis are the two ailments commonly designated to the different types of Inflammatory Bowel Disease (IBD).

Inflammatory Bowel Disease often occurs early in life, mainly between the ages of 15 and 25. Approximately 25% of Inflammatory Bowel Disease sufferers have a direct relative who also has the disease. Jewish Americans are roughly four to five times more likely to develop IBD than the rest of the population.

The most common symptom of Inflammatory Bowel Disease is diarrhea, sometimes severe enough to require frequent trips to a toilet (up to 20 or more times a day). Other common symptoms include:

Abdominal cramps
Blocked bowels
Fever
Bloody Stool
Loss of body fluids
Loss of appetite
Extreme weight loss
Anemia

Many people who suffer from IBD also experience such conditions as arthritis and inflammation of the eye, skin and liver. Inflammatory Bowel Disease is also considered to be a major risk factor for developing colorectal cancer.

Children troubled with Inflammatory Bowel Disease frequently suffer from retarded growth and delays in the onset of puberty. The struggle continues into adulthood as patients suffer new bouts with the disease. Once Inflammatory Bowel Disease has taken hold, symptoms can flare up without warning, leaving victims constantly worried over when the next episode will strike; how severe it will be and how long it will last.

If you or a loved one has taken Accutane or Zelnorm and have been diagnosed with Inflammatory bowel disease (IBD), please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.