The FDA's request is based primarily on the results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study, an approximately 10,000 patient, 6-year study requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. The majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling.
The SCOUT results are in contrast to the vast body of sibutramine data for the on-label patient population, including 46 controlled clinical trials and more than 6 million patient years of use accumulated over 13 years during which the product has been available. These data fail to confirm the excess cardiovascular risk found in the SCOUT study.
The voluntary withdrawal of sibutramine in the U.S. follows an 11-month process, beginning in November 2009, when Abbott promptly notified FDA of the SCOUT preliminary results immediately after receiving those results. The European Medicines Agency (EMA) suspended marketing authorization for all anti-obesity medicines containing sibutramine in January 2010.
Abbott submitted label changes to FDA in January 2010 to further ensure appropriate use of the product based on the preliminary SCOUT findings. Over the course of the next nine months, Abbott conducted and provided numerous analyses to FDA and other global regulatory authorities for the purpose of determining the applicability of the SCOUT data to the approved patient population. These analyses confirmed the appropriateness of the current label: that people with preexisting cardiovascular disease should not take the medication. These analyses also confirmed there was no excess risk in the approved patient population.
Abbott provided a comprehensive review of these analyses at the Sept. 15, 2010, public advisory panel with 16 experts selected by FDA. That panel reviewed and debated the available data on sibutramine. The results of the panel's deliberations - an 8-8 split decision with eight advisers voting in favor of enhanced labeling and risk management activities compared to eight advisers in favor of withdrawal - highlights the complexity of the scientific debate and the different interpretations of the data, even by independent experts.
Abbott believes sibutramine has a positive risk/benefit profile in the approved patient population, but will comply with the FDA's request.
Patients should discontinue use of sibutramine and consult their physician for alternatives. Patients can call Abbott's medical information line in the U.S. at 1-866-257-8909 or visit www.sibutramine.com
Abbott is having ongoing discussions with regulatory authorities in countries where sibutramine is marketed and anticipates concluding those discussions in the coming days.
The following information reflects current product labeling and has always been provided to health care providers and in public communications about Meridia.
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:
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:
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 nearly 90,000 people and markets its products in more than 130 countries.