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. Now an FDA insider is naming several more drugs with safety concerns.

Bextra (valdecoxib) might increase the risk of heart attack... similar to Vioxx. FDA was quick to add a contraindication for patients having bypass surgery. FDA also added a new "black box" warning about serious skin reactions.

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raising questions about FDA's drug approval and surveillance process
Diabetes Reps will be touting evidence that suggests carvedilol is better than metoprolol for diabetes patients
Fibromyalgia what really works for fibromyalgia
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
Light therapy is often as effective as antidepressants for seasonal affective disorder (SAD)
Ritalin, Adderall, and other stimulants to enhance test scores
Antiarrhythmics flecainide (Tambocor) or propafenone (Rythmol) written "take as needed for atrial fibrillation"
Multiple Sclerosis Tysabri (tie-SAB-ree), the latest treatment for multiple sclerosis (MS)
Multiple Sclerosis Aricept and other cholinesterase inhibitors for patients with multiple sclerosis
Women's Health the risk of bone loss in women using Depo-Provera
Women's Health whether testosterone is appropriate for treating sexual dysfunction in women
Hematology & Oncology More women with EARLY breast cancer will be treated with an aromatase inhibitor
Hematology & Oncology Tarceva (erlotinib), a new ORAL treatment for non-small cell lung cancer (NSCLC)
Supplements DHEA for weight loss
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 advice on drug therapy, plus unlimited access to CE

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