raising questions about FDA's drug approval and surveillance process

January 2005

A firestorm of press is raising questions about FDA's drug approval and surveillance process.

It started with the Vioxx revelations. Then an FDA insider fueled the fires with congressional testimony naming several more drugs with safety concerns.

Crestor (rosuvastatin) is under scrutiny for rhabdomyolysis and renal failure. FDA is keeping a close eye on it. For now, avoid high doses...especially in patients over 65, with severe renal insufficiency, or those taking gemfibrozil or cyclosporine.

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raising questions about FDA's drug approval and surveillance process
Cardiology Reps will be saying that amlodipine (Norvasc) reduces the risk of cardiovascular events
Cardiology BiDil will be the first drug approved specifically for African Americans
Diabetes Reps will be touting evidence that suggests carvedilol is better than metoprolol for diabetes patients
Diabetes Endocrinology whether to treat patients with subclinical hypothyroidism
Fibromyalgia what really works for fibromyalgia
Supplements DHEA for weight loss
Psychiatry Light therapy is often as effective as antidepressants for seasonal affective disorder (SAD)
Psychiatry Ritalin, Adderall, and other ADHD drugs to enhance test scores
Women s Health whether testosterone is appropriate for treating sexual dysfunction in women
Women s Health the risk of bone loss in women using Depo-Provera
Multiple Sclerosis Tysabri (tie-SAB-ree), the latest treatment for multiple sclerosis (MS)
Hematology Oncology Tarceva (erlotinib), a new ORAL treatment for non-small cell lung cancer (NSCLC)
Hematology Oncology More women with EARLY breast cancer will be treated with an aromatase inhibitor
Antiarrhythmics flecainide (Tambocor) or propafenone (Rythmol) as needed for atrial fibrillation
Practice End of year is a good time to reflect on trustworthy drug information that is relevant to practice.

raising questions about FDA's drug approval and surveillance process

Get concise, unbiased advice for effective drug therapy, plus CE/CME

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