FDA

Expert committee recommends Avastin (bevacizumab) FDA approval for breast cancer be revoked

people with backs turned  An expert panel voted unanimously to remove the FDA approval for Bavacizumab (Avastin) in treatment of breast cancer.

Lipitor, Zocor and Pravachol in high doses appear to pose increased risk of diabetes

man at desk thinking Two years ago, what researchers call a “signal of risk” was identified for one member of the cholesterol lowering drugs known as statins (what your doctor would call HMG-Co-A reductase inhibitors) app

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man at desk thinking Two years ago, what researchers call a “signal of risk” was identified for one member of the cholesterol lowering drugs known as statins (what your doctor would call HMG-Co-A reductase inhibitors) appeared in the JUPITER study for Crestor (rosuvastatin) [Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomized statins trails. Lancet 2010; 375:735-742]. What this meant was that Crestor appeared to be associated with about a 9% increased risk of diabetes.

A new study being presented at the American Diabetes Association-ADA meeting (Preiss D, Sesshasai, SR, Welsh P, et al. Risk of incident diabetes with intensive-dose compared to moderate-dose statin therapy. JAMA 2011; 305:2556-2564) looked at 32,752 people. The studies reviewed included A to Z, IDEAL, PROVE-IT, SEARCH and TNT. What this new analysis found was that high dose statin use (Lipitor-Atorvastatin, Pravachol-pravastatin and Zocor-simvastatin) appears to carry roughly a 12% increased diabetes risk. It is crucial to remember that overall, the benefits (avoiding heart disease and heart attack, etc.) outweigh the risk of diabetes for this family of medicines.

members circle The studies reviewed looked at Lipitor, Pravachol and Zocor. Prove IT compared 40 mg of Pravachol to 80 mg of Lipitor in 4,162 people. A to Z had a more complicated format, but looked at a given time of Zocor 40 mg then changed to 80 mg of Zocor in some patients. Other patients received 4 months of dietary counseling and placebo followed by 20 mg of Zocor for roughly 4,500 people. TNT was a large study of 15,464 people and involved treating to new targets and compared 80 mg of Lipitor to 10 mg of Lipitor. IDEAL looked at 8,888 people after a heart attack and compared 80 mg of Lipitor to 20 mg of Zocor. Finally, SEARCH looked at 80 mg of Zocor compared to 20 mg of Zocor and also tried to sort out the role of folic acid and vitamin B 12

As always, talk to your doctor about any questions regarding your medicines BEFORE you make any changes in your treatments. Visit Amazon author central:

http://www.amazon.com/James-J.-Rybacki/e/B000APKNZM to find the EGPD update on statins and cholesterol with recommendations about diabetes testing and statin use.

Yervoy (ipilimumab) approved for melanoma by the FDA

sears tower  A medicine which first received notariety at the American Society of Clinical Oncologists (ASCO) this summer was approved by the FDA today. This drug is the first in a new family of medicines called anti-CTLA 4 inhibitors.

Approval Date: 
Fri, 03/25/2011
Company: 
Bristol-Myers squibb

Waiting for weight loss and Contrave

woman with blue face Are you getting blue in the face waiting for a new prescription weight loss drug? Today may be your day. The expert advisory committee of the FDA (Endocrine and Metabolic) recommended that the FDA approve Contrave.

Approval Date: 
Mon, 01/31/2011
Company: 
Orexigen

Breast implants associated with rare lymphoma

younger and older woman upset   Shortly after noon on the 26th, the FDA reported that there is a possible association with silicone gel filled  and saline filled breast implants and lymphoma. The specific cancer is called anaplastic large cell lymphoma (ALCL) which is very rare.

FDA Fails or FDA Failed to be supported?

skeptical women The FDA approved the smallest number of medicines since 2007 last year and let only 21 new drugs into the realm of approved medicines. Is this a failure, triumph or funding shortfall?

This website is not intended as medical advice, and you should consult your doctor before changing or adding any medicines or vitamins to those you may now be taking and about applying any strategies BEFORE you adopt any approach in this report. While diligent care has been taken to ensure the accuracy of the information provided during the preparation of this edition, no claim is made that all known actions, uses or side effects, strategies for cost containment, targets or cholesterol pathways are included in this report. The accuracy and currentness of information are ever subject to change relative to new guidelines, new information derived from drug research, development and general usage.