Abbott Laboratories has voluntarily withdrawn its obesity drug sibutramine (Meridia) from the US market after the FDA concluded that the drug’s very modest benefits did not outweigh the risk of MI and stroke associated with the drug. The drug was pulled from the European market earlier this year.
Here’s a link to the FDA Communication: Drug Safety Communication: FDA Recommends against the Continued Use of Meridia (sibutramine)
Here is the FDA press release:
Abbott Laboratories agrees to withdraw its obesity drug Meridia
Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.”
Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.
The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine and another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.
“The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.
The agency’s analysis of SCOUT was the subject of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.
For more information:
Drug Safety Communication: FDA Recommends against the Continued Use of Meridia (sibutramine)
Here is the Abbott press release:
Abbott to Voluntarily Withdraw Meridia® (Sibutramine) in the U.S.
October 8, 2010
Abbott Park, Illinois (NYSE: ABT) — Abbott will voluntarily withdraw Meridia® (sibutramine) from the U.S. market at the request of the U.S. Food and Drug Administration (FDA).
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 advisors voting in favor of enhanced labeling and risk management activities compared to eight advisors 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:
- 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
- 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 two weeks. MAOIs should not be taken for at least two weeks before using Meridia. MAOIs should not be taken for at least two 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.
Abbott (NYSE: ABT) 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.