Some Patients May Experience Death:

The FDA or Food And Drug Administration has got to be the worst of all of the US government agencies and is filled with bureaucratic red tape involving new drug approval:

"More and more Americans suffer from Alzheimer’s disease either as victims or care givers. So when a vaccine was developed that may actually reverse this terrible, degenerative process, you would think it would be welcomed and fast-tracked through the federal bureaucracy. Think again. FDA reviewers abruptly called a complete halt to the study – and delayed development for two whole years – because about 4 percent of those in the safety study contracted encephalitis, a very treatable disease."

Source: Senior Journal

On the other side of the coin recent approval of new drugs without sufficient clinical trials has resulted in numerous class action law suits including these familiar names:

Cisapride, Dostinex, Doxylamine, Celebrex, Fosamax, Olestra, Ortho Evra, Oxycontin, Permax, Trasylol, Vioxx, and many many others.

"The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials for reforms in the FDA's procedures for pre- and post- market drug safety regulation."

Source: Wikipedia-FDA

When taking a new drug that is proclaimed to work miracles just remember that you are now taking your health and your life in your on hands.