Posts Tagged ‘Heart Failure’

Warning on Dietary Supplement Venom Hyperdrive 3.0 (April 2009)

Friday, April 10th, 2009

Video originally created by FDA -- posted by Lawsuit.com on April 9th, 2009

FDA is warning consumers not to take the dietary supplement “Venom Hyperdrive 3.0,” which has been promoted for weight loss. This product has been found to contain sibutramine, a prescription drug used as an appetite suppressant under medical supervision. Sibutramine can increase blood pressure and heart rate, and may pose a significant risk for people with a history of heart disease, heart failure, arrhythmias or stroke. It also has the potential for abuse or addiction.

Venom Hyperdrive 3.0 is marketed by Applied Lifescience Research Industries. The product was sold via distributors and in retail stores nationwide, and also in a number of other countries. It was packaged in red plastic bottles containing 90 capsules each. The company recalled the product after the FDA’s laboratory analysis showed that samples contained sibutramine in significant amounts.

Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects.

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Avoiding Cardiotoxicity with Mitoxantrone

Tuesday, March 3rd, 2009

Video originally created by FDA -- posted by Lawsuit.com on October 13, 2008

FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis (MS).

Congestive heart failure can occur while a patient is being treated with mitoxantrone, or even months or years after therapy is stopped. The risk of cardiotoxicity increases as the cumulative dose increases.

In 2005, the product labeling was updated to recommend that MS patients have their left ventricular ejection fraction (LVEF) checked before each dose of mitozantrone, in addition to having a baseline measurement before starting treatment. Since that time, a postmarketing safety study has shown that quantitative LVEF monitoring was not being performed in a majority of MS patients treated with the drug.

Given the possibility of severe cardiotoxicity, FDA is reminding healthcare professionals about the importance of cardiac monitoring of MS patients during treatment with mitoxantrone. Also, FDA is now advising that all MS patients who have finished mitoxantrone receive yearly quantitative LVEF evaluation to detect late-occurring cardiac toxicity.

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Heart Failure and Some Diabetes Drugs (October 2007)

Friday, November 21st, 2008

Video originally created by FDA -- posted by Lawsuit.com on March 18, 2008

The manufacturers of thiazolidinedione drugs have strengthened warnings about the risks of heart failure with these medications, which are use to treat type 2 diabetes. They are sold as Avandia (rosiglitazone maleate), Avandaryl (rosiglitazone maleate and glimepiride), and Avandamet (rosiglitazone maleate and metformin hydrochloride), which all contain rosiglitazone, and Actos (pioglitazone hydrochloride), Duetact (pioglitazone hydrochloride and glimepride) and Actoplus met, which all contain pioglitazone.

The drug labels already had information about heart failure risk, but now there is a new boxed warning that re-emphasizes that these drugs may cause or worsen heart failure in certain patients, and stresses the importance of carefully monitoring patients for signs of heart failure.

The labeling recommends that after starting thiazolidinedione therapy or increasing the dose, patients should be observed carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema. If any of these signs and symptoms develop and heart failure is confirmed, practitioners should start appropriate management of the heart failure and consider stopping or reducing the dose of the drug. The boxed warning also notes that these drugs are not recommended for patients with symptomatic heart failure, and are specifically contraindicated in patients with NYHA Class III or IV heart failure.

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