Charlotte Personal Injury Lawyer - FDA

FDA Starts Safety Review Of Weight Loss Drug Meridia

Greg Jones — Tue, 24 Nov 2009 09:25:09 GMT

The U.S. Food and Drug Administration has begun an expedited safety review of sibutramine based on a recent study showing that some patients have a higher rate of heart attacks, strokes and other cardiovascular events after taking the weight loss drug. Abbott Laboratories markets sibutramine as the popular weight loss drug Meridia.

Although the FDA has not made any conclusions, it is studying the initial data from a six-year study referred to a s the SCOUT study which examined the effects of the drug on overweight or obese subjects at risk of a cardiovascular event.

The SCOUT study results demonstrate the need for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke to avoid using sibutramine or Meridia.

The SCOUT data looked at roughly 10,000 patients who were at least 55, overweight or obese and had a history or heart disease or type 2 diabetes as well as at least one other cardiovascular risk factor. The study did not include those who had recently suffered a heart attack or stroke. The study was designed to demonstrate that weight loss achieved through sibutramine and "standard care" lowered the number of cardiovascular events more effectively than weight loss reached through a placebo and standard care.

The FDA said it "understands the serious nature of the preliminary data" and vowed to share its conclusions with the public as soon as it finishes its expedited safety review.

Originally posted at InjuryBoard by Greg Jones

FDA Panel Urges Ban on Vicodin, Percocet

Greg Jones — Wed, 01 Jul 2009 10:47:48 GMT

Following the release of an FDA report last month that found severe liver damage, and even death, due to consumer's lack of awareness that acetaminophen can cause serious injury, an FDA panel is urging that the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, be banned. The FDA panel is also urging the lowering of the the maximum dose of over-the-counter painkillers with acetaminophen, like Tylenol or Excedrin.

The panel showed a rear concern with the potential abuse of Vicodin and Percocet but went further to caution on the OTC, over the counter, drugs as well. The panel believed that people often consume more of the recommended dose of acetaminophen mistakenly thinking that taking more will be better against pain without posing any health risks

The FDA is not obligated to follow the recommendations of its advisory panels, but it usually does.

Please be diligent with your intake of medicine, either over the counter or prescription, that contain acetaminophen. Especially in the case of children, side effects can be quite serious if over adminsitered. This should hlep remind us all that even seemingless harmless drugs that must of us keep in our medicine cabinets have potentially harmful side effects that should not be ignored.

Originally posted at InjuryBoard by Greg Jones

Recall of certain Medtronic Kappa and Sigma Series pacemakers

Greg Jones — Thu, 11 Jun 2009 13:53:23 GMT

The FDA just announced Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Medtronic Kappa Series 600/700 and 900 as well as Sigma Series Series 100,200 and 300 pacemakers were involved in the recall.

Originally posted at InjuryBoard by Greg Jones