Celexa doses greater than 40 mg are no longer recommended by the FDA because they may be associated with increased risk of abnormal heart electrical activity.
The first of a new kind of lab test and a first-in-the-class therapy have been approved by the FDA. Zelboraf (vemurafenib) was approved by the FDA under the priority review program.
An expert panel voted unanimously to remove the FDA approval for Bavacizumab (Avastin) in treatment of breast cancer.
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
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.
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.
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.
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.
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.
In the first FDA press/news release of 2011, the FDA notes that it will require substantial equivalence reviews for new tobacco products.