{"id":113256,"date":"2009-11-30T16:40:00","date_gmt":"2009-11-30T21:40:00","guid":{"rendered":"tag:typepad.com,2003:post-6a00d8341c89dd53ef012875cbb33d970c"},"modified":"2009-12-04T08:53:57","modified_gmt":"2009-12-04T13:53:57","slug":"diet-drug-meridia-has-possible-cardiovascular-risks-including-stroke-heart-attack-and-cardiac-death","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/113256","title":{"rendered":"Diet Drug Meridia Has Possible Cardiovascular Risks, Including Stroke, Heart Attack, And Cardiac Death"},"content":{"rendered":"
\n

FDA Early Communication About Meridia (Sibutramine) Side Effects Issued by Agency In November 2009<\/span><\/span><\/span><\/strong><\/p>\n

(Posted by Tom Lamb at DrugInjuryWatch.com<\/strong><\/font><\/span><\/a>)<\/strong><\/font><\/strong><\/font><\/span><\/span><\/span><\/span><\/p>\n

On November 20, 2009 the FDA issued an “Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)”<\/a>\u00a0to let patients and their doctors know about a possible increased risk for adverse cardiovascular events associated with the obesity drug Meridia.<\/p>\n

As background, Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet.\u00a0 Meridia is marketed by Abbott Laboratories in the U.S.<\/p>\n

A November 21, 2009 article, “Early Data Link Diet Drug to MI, Stroke, and Cardiac Death”<\/a>, published online by MedPage Today<\/em>, provides a good summary of the basis for this Meridia safety alert:<\/p>\n

\n

Preliminary analysis of data from a placebo-controlled study of sibutramine (Meridia) suggested an excess risk of cardiovascular events including myocardial infarction and cardiac death among patients taking the diet drug, according to the FDA.<\/p>\n

The findings come from a trial of 10,000 high-risk patients who were randomized to sibutramine or placebo. The FDA said there was a 1% absolute difference in the rate of heart attack, stroke, resuscitated cardiac arrest, or death with 11% of the sibutramine patients reaching that endpoint versus 10% of the placebo patients.<\/p>\n

The difference, while small, “is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population,” the FDA said….<\/p>\n

The findings come from the SCOUT trial (Sibutramine Cardiovascular Morbidity\/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) which had a combined primary endpoint of heart attack, stroke, resuscitated cardiac arrest, or death.<\/p>\n

The study, begun in 2002, was conducted as part of a postapproval agreement with the agency that oversees drug approvals for the European Union.<\/p>\n<\/blockquote>\n

We last wrote about cardiovascular side effects being associated with Meridia use back in October 2007, when Health Canada provided an update on reports of suspected Meridia adverse reactions<\/a>.<\/p>\n

P.S.<\/strong>\u00a0 An update by means of this December 3, 2009 Reuters<\/em> article: “US consumer group asks FDA to ban Abbott diet drug — Public Citizen says Meridia increases heart risks”<\/a>.\u00a0 (12\/4\/09)<\/p>\n

______________________________________________________________________________<\/p>\n

DrugInjuryLaw.com<\/font><\/span><\/strong><\/a>: Legal Information And News About Prescription Drug Side Effects<\/strong><\/span><\/span><\/span><\/span><\/p>\n