On Wed., Sept. 1, the New England Journal of Medicine weighed in with an editorial calling for it to be pulled from the market after a new study revealed an increased risk for heart attacks in some patients.

The unusually critical editorial came as a result of the largest long-term study of Meridia. Almost 10,000 overweight or obese people with cardiovascular disease or diabetes were followed for three and a half years, reports CBS News medical correspondent Dr. Jonathan LaPook.

The group taking Meridia lost on average about 9 lbs., but had a 16 percent higher risk of suffering a heart attack or stroke.

The drug company, Abbott, told CBS News there’s already a label warning that the drug should not be used in patients with known cardiovascular disease.

But the editors of the New England Journal wrote that since Meridia has “a worrisome cardiovascular risk profile,” that “it is difficult to discern a credible rationale for keeping this medication on the market.”

“Meridia plays a small but significant role,” said Dr. Louis Aronne, a weight loss expert who has advised Abbott. “We use Meridia when other types of treatments down’t work.

An FDA committee will meet in two weeks to decide Meridia’s fate.

Courtesy: CBS News

NEW YORK —  Acne is a difficult enough burden for a young person to bear. Now there’s evidence that antibiotics commonly prescribed to help control severe breakouts may, in a very small number of patients, lead to inflammatory bowel disease.

Bowel disorders linked to acne treatment are “a rare outcome,” cautioned Dr. David Margolis, a dermatologist and lead author of a study in the American Journal of Gastroenterology, in an interview with Reuters Health.

Nonetheless, previous studies have suggested that the acne drug isotretinoin, known commonly by the brand name Accutane, might be the cause of inflammatory bowel disease in a small number of patients being treated for severe acne.

Noting that most people given isotretinoin have already been taking antibiotics for months, if not years, Margolis and colleagues at the University of Pennsylvania wanted to know if antibiotics might play a role in triggering the bowel condition.

Up to 90 percent of teenagers and young adults battle acne at some point. Drugs from the tetracycline family are the most commonly prescribed antibiotics for the treatment of severe acne.

“They limit scarring and the outbreak of pimples. They’re exceedingly effective and have been used for years,” Margolis said.

The researchers looked at the medical records of more than 94,000 British teenagers and young adults diagnosed with acne between 1998 and 2006.

They found that long-term use of antibiotics appeared to double the risk of developing inflammatory bowel disease in these subjects. Of the 207 cases of inflammatory bowel disease diagnosed among the 94,487 patients in the study, 152 (0.26 percent of all subjects) were taking one of three commonly prescribed tetracycline-based antibiotics and 55 (0.14 percent) were not.

Patients taking one of the three drugs, doxycycline, appeared to be at a slightly higher risk (0.21 percent) of developing an inflammatory bowel disease compared to patients taking minocycline (0.17 percent risk) or tetracycline (0.20 percent risk).

“The association was probably most pronounced in terms of Crohn’s disease, a subgroup,” Margolis said.

Crohn’s disease is an inflammation of the lining of the digestive tract, which can lead to abdominal pain, severe diarrhea and malnutrition. It affects an estimated 400,000 people in the U.S. Some 600,000 Americans suffer another inflammatory bowel disease, ulcerative colitis

. Both are treated with anti-inflammatory drugs and some complications of the conditions can require surgery.

“This potential risk should be considered when prescribing this medication,” the authors write, while also urging more study of the connection between acne drugs and bowel disorders. It is possible, for instance, that the risk of inflammatory bowel disease is related to the biology of severe acne itself and not to treatments for it, they note.

“This is a rare outcome, rare enough you need to be careful about making decisions to change clinical practice,” Margolis said.

Inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis, can be life-altering conditions that restrict social interactions and increase depression.

Severe acne is also a “bad disease,” Margolis said. “These people have lots of concerns about their health, their appearance and how they function in society, and they are at an increased risk of depression,” Margolis pointed out.

Margolis was prompted to conduct the study after being asked to review records by lawyers representing a generic manufacturer of isotretinoin. The legal case is still in the discovery phase.

“I’m not sure if isotretinoin (Accutane) is on or off the hook all by itself,” he said. “I think this research indicates that in a careful study one should probably consider antibiotic use,” as well, he added.

Source: Reuters

Actor John Marshall has filed suit against Roche AG, the maker of Accutane. The 43-year-old Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie “A Few Good Men,” claims he developed inflammatory bowel disease, or IBD, from taking Accutane. The disease, Marshall alleges, ruined his acting career.

Marshall’s Accutane lawsuit is scheduled for trial next week. According to Bloomberg.com, it promises to be a star-studded affair. Fellow actors Martin Sheen, Brian Dennehy and Esai Morales, along with director Rob Reiner, are scheduled to testify on Marshall’s behalf. They will attest to Marshall’s potential as an actor prior to his development of IBD, his lawyer said.

According to his lawsuit, doctors were forced to remove Marshall’s colon because of his alleged Accutane injuries. He claims Roche failed to warn patients that the drug could cause IBD in some users.

Marshall’s case has been combined with claims by two other former Accutane users for trial before Judge Carol Higbee in state court in Atlantic City, Bloomberg said.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. 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 hundreds of 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.

Last summer, Roche decided to stop marketing Accutane for economic reasons. In announcing the decision, Roche cited the high cost of product liability suits involving the drug as one of the factors in the decision.

According to Bloomberg, Roche has lost all seven Accutane cases that have been considered by juries since 2007, including the last three in a row. Juries in New Jersey and Florida ordered the drug maker to pay a total of at least $45 million in damages in those cases. However, appeals courts later threw out two of the verdicts, including a 2007 award of $7 million to a Florida man who blamed the drug for IBD.

Source: News Inferno

Last year, the Food & Drug Administration issued a black box warning, the strongest of its kind, for the drug Reglan and its generic forms metoclopramide, stating that the medication had “been linked to tardive dyskinesia.” In fact, Reglan and metoclopramide use has been identified as the leading cause of tardive dyskinesia (TD) among patients with the disorder in the United States.

The FDA approved Reglan for short-term use – no longer than three months – in 1979 as a treatment for various gastrointestinal disorders, namely gastroparesis and gastroesophageal reflux disease (GERD). But, prior to the FDA’s action last year, the very serious risks posed by the drug were not made clear to the public on its labeling. As a result, several lawsuits have been filed across the country against the drug’s manufacturers.

Evidence of the risks posed by Reglan and metoclopramide had been around for years. In 1983 the Annals of Internal Medicine ran a letter warning of metoclopramide’s possible neurological side effects, including TD. A Neurology study published in 1984, found that the incidence rate of TD was two to three times higher for long-term metoclopramide patients 70 and older. And by 1992, the Archives of Family Medicine was expressing serious concerns about the dangers of long-term metoclopramide use, particularly in the elderly and diabetic.

Despite these studies displaying that Reglan and metoclopramide posed a clear risk to patients, the drug’s manufacturers did nothing to alert the public of the danger. Even more troubling is the fact that there was significant evidence released over the last 30 years that showed the drug had little to no value as a treatment for GERD.

A study published in Gastroenterology in 1975, four years before Reglan was approved by the FDA, acknowledged that while the drug might provide some relief for GERD patients, it had little to no effect on serum gastrin levels. The American Journal of Gastroenterology published another study in 1983 concluding that while metoclopramide provided temporary relief of GERD symptoms, it had no significant effect on symptoms of esophagitis. And finally, a 2006 study published in Nature Clinical Practice: Gastroenterology & Hepatology concluded that “the evidence base for the use of [metoclopramide for GERD] is weak, with little or no sustained effect on acid exposure or healing of esophagitis.”

These medical studies, along with the fact that metoclopramide is only approved for short-term use, while GERD is generally a chronic condition, suggest that there is very little value in metoclopramide for treating patients suffering from GERD. And with the significant health risks posed by the drugs, it seems only logical that the FDA should withdraw its approval of the medication for treatment of the condition. The companies that continued to market the drug despite the evidence listed above must be held accountable for the injuries caused in the thousands of patients taking their product over the last three decades.