Abbott Statement on the FDA Advisory Committee Recommendation on Sibutramine

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Sep 15, 2010, 05:03 ET

ABBOTT PARK, Ill., Sept. 15 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and the weight loss medication sibutramine (sold as Meridia® in the United States). In response to the Advisory Committee's mixed vote, Abbott (NYSE: ABT) issued the following statement:

"Today's vote highlights the complexity of this scientific debate," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine. Sibutramine is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available, and Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine."

"Sibutramine has been studied in more than 100 clinical trials involving more than 20,000 patients, in addition to those involved in the SCOUT study," said Sun. "SCOUT did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended and its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA during its decision-making process for Meridia. Abbott intends to consult with the FDA on sibutramine moving forward.

Sibutramine is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease. The approximately 10,000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment. More than 90 percent of the patients studied in SCOUT had underlying cardiovascular disease or were otherwise ineligible to receive sibutramine under the current labeling and prescribing information.

Use

Meridia (sibutramine hydrochloride monohydrate) is a prescription medicine used to help overweight or obese people lose weight. Meridia should be used together with a low-calorie diet.

Important Safety Information

Meridia is not for everyone. People should not take Meridia if they"

have or have had, heart problems, including:
- heart attack
- chest pain
- heart failure
- fast or irregular heart beat
- hardening of their arteries or other blood vessels
- poor circulation in their legs
have or have ever had a stroke or symptoms of a stroke.
uncontrolled or poorly controlled blood pressure (above 145/90).
are over age 65.
are taking or have taken a type of medicine used to treat depression called a monoamine oxidase inhibitor (MAOI) in the past 2 weeks. MAOIs should not be taken for at least 2 weeks before using Meridia. MAOIs should not be taken for at least 2 weeks after stopping Meridia. People should ask their doctor or pharmacist if they are not sure if any of their medicines are MAOIs.
have an eating problem called anorexia nervosa or bulimia nervosa.
are taking certain other weight loss medicines.
are allergic to sibutramine hydrochloride monohydrate or any other ingredients in Meridia.

Meridia can cause serious side effects including large increases in blood pressure or heart rate (pulse) in some people. Patients should call their doctor right away if they check their blood pressure and it is higher than normal for them, or if they have symptoms of high blood pressure such as headache, dizziness or blurred vision.

Before starting Meridia, patients should have their blood pressure and heart rate checked by their doctor. Their doctor should continue checking their blood pressure regularly while taking Meridia. It is important that patients have regular check-ups with their doctor while they are taking Meridia.

People should not take Meridia if they have severe liver or kidney disease, are pregnant or planning to get pregnant or if they are nursing.

Patients should tell their doctor if they have or ever have had glaucoma, kidney or liver problems, seizures, bleeding problems, gallstones or depression, are pregnant or planning to become pregnant, or are breastfeeding.

Using Meridia with certain other medicines may affect how Meridia or the other medicines work. Patients should tell their doctor about all the medications they take, including prescription and non-prescription medicines, vitamins and herbal supplements. Patients should especially tell their doctor if they take: a monoamine oxidase inhibitor (MAOI) medicine, other weight loss medicines, cough and cold medicines, migraine headache medicines, medicines used to treat depression, narcotic pain medications, lithium, tryptophan, or medicines that thin the blood.

Meridia may cause serious side effects, including:

Serotonin syndrome, which may happen when people take Meridia with certain other medicines that affect a brain chemical called serotonin. Patients should not take other medicines with Meridia unless their doctor has told them to. Patients should get medical help right away if they have any of the following symptoms:
- feel weak, restless, confused or anxious
- lose consciousness (faint)
- have a fever, vomiting, sweating, shivering or shaking
- have a fast heart beat
seizures (convulsions, fits)
bleeding. Bleeding may happen if patients have a condition that causes bleeding or if they take a blood thinning medicine.

Certain weight loss medicines have a rare but life-threatening problem that affects blood pressure in the lungs (pulmonary hypertension). It is not known if Meridia may cause this problem. Patients should call their doctor right away if they have new or worsening shortness of breath.

The most common side effects include dry mouth, loss of appetite, trouble sleeping, constipation and headache.

Patients should not drive, operate heavy machinery or do other dangerous activities until they know how Meridia affects them.

Never give Meridia to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.

This is some of the most important information to know about Meridia. For more information, patients should talk with their health care provider.

About Abbott

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 approximately 83,000 people and markets its products in more than 130 countries.

Abbott information is available on the company's Web site at www.abbott.com.

SOURCE Abbott