Abbott Statement Regarding U.S. Food and Drug Administration's Denial of Public Citizen's Petition Against Meridia(R) (sibutramine HCL monohydrate) Capsules C-IV

ABBOTT PARK, Ill., Aug. 17 /PRNewswire/ -- Abbott issued the following statement in response to the U.S. Food and Drug Administration's (FDA) decision to deny Public Citizen's petition against Meridia(R) (sibutramine HCL monohydrate) capsules C-IV. The FDA concluded that "sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients."

"Public Citizen's initial petition was not based on valid scientific analysis, minimized the seriousness of obesity and unnecessarily alarmed and misled patients. Patients must be afforded every possible, effective treatment option when it comes to fighting obesity. The FDA's decision supports this and ensures that patients and doctors will continue to have access to an important treatment option for obesity," said Robert Kushner, M.D., professor of medicine, Northwestern University Feinberg School of Medicine and medical director of the Wellness Institute, Northwestern Memorial Hospital.

Obesity is a serious disease and a major risk factor for the development of life-threatening illnesses such as coronary heart disease, hypertension, stroke, diabetes and certain types of cancer.

"Obese patients represent nearly one third of all American adults," said Donna H. Ryan, M.D., professor of medicine and associate executive director of clinical research at Louisiana State University System Pennington Biomedical Research Center. "The FDA has recognized in its response to Public Citizen that, when used by the appropriate patient, sibutramine-associated weight loss is accompanied by a number of benefits, including improvements in important lipid parameters."

Meridia has been approved as a safe and effective treatment for obese patients (for people who need to lose 30 pounds or more depending on height) when combined with diet and exercise. Meridia has been extensively studied in more than 100 clinical trials involving more than 12,000 patients throughout the world. Approximately 15 million patients in more than 75 countries have used sibutramine for the treatment of obesity since it was approved in 1997. As part of its commitment to patient safety, Abbott developed and implemented in early 2005 a program to reinforce the appropriate use of Meridia that enhances materials already in place and includes an educational outreach program to physicians.

"The FDA's decision supports what we have long known, that Meridia, when used in accordance with the prescribing information and combined with diet and exercise, is a safe and effective option for the treatment of obesity," said John Leonard, M.D., vice president, Global Medical and Scientific Affairs, Abbott. "This decision is good news for obese patients and their physicians who are considering pharmacotherapy who may have been alarmed by Public Citizen's campaign of fear, confusion and misinformation."

Meridia is an important option for appropriate patients with obesity who, without assistance of pharmacotherapy, may be unable to manage their weight. Multiple clinical trials have demonstrated that the majority of patients treated with Meridia, in addition to diet and exercise, lost at least 5 to 10 percent of their body weight. In a two-year trial, nearly three times as many obese patients taking Meridia in conjunction with diet and exercise maintained at least 80 percent of their initial six-month weight loss when compared to patients practicing diet and exercise alone. Research has shown that maintaining weight loss of 5 to 10 percent of body weight significantly reduces risk of obesity-related adverse health conditions.

In 2002 the European Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion, which reaffirmed the favorable risk-benefit profile of Meridia for the treatment of obesity.

Meridia(R) (sibutramine HCL monohydrate) Capsules C-IV Use and Safety Information

Meridia is available only by prescription. Meridia is indicated for people who need to lose 30 pounds or more depending on height, and should be used in conjunction with a reduced calorie diet.

Meridia is not for everyone including persons who are allergic to any of the ingredients of Meridia, those with anorexia nervosa, bulimia nervosa, or who are taking monoamine oxidase inhibitors (MAOIs) or weight-loss medications that control appetite.

Meridia substantially increases blood pressure or heart rate in some patients and should not be given to patients with uncontrolled or poorly controlled hypertension, history of heart disease, stroke, severe liver or kidney disease, pregnant women or nursing mothers. Meridia should be used cautiously in patients with a history of hypertension, glaucoma, seizures or mild to moderate kidney impairment. All patients being treated with Meridia should see their doctor as directed for regular monitoring of blood pressure and heart rate.

It is important that patients tell their health care provider about all current and past medical problems. Patients must not take other medicines with Meridia unless their doctor has told them that it is okay to do so. Patients should talk to their doctor about all medications (including prescriptions for depression, and those which may increase risk of bleeding), over-the-counter medicines, such as cough and cold, and herbal products that they are currently taking or have recently taken.

Meridia is a controlled substance (C-IV). This means that Meridia can be a target for people who abuse prescription medicines. Meridia should be kept in a safe place. Selling or giving away Meridia is against the law.

The most common side effects include headache, dry mouth, anorexia, constipation and insomnia.

For more information about Meridia (sibutramine HCL monohydrate) C-IV, including full prescribing information, please visit http://www.meridia.net/ .

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.

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