The interesting findings of the FDA consultant Dr. David Gortler brought revolutionary changes in the industry of medicine. Statins, a class of medication that has the capability to reduce the level of cholesterol in the blood stream has been widely used. The drugs chosen for an important research were simvastatin 80mg and simvastatin 20mg. The former one is a high dose statin medication and is commonly prescribed as this is least expensive when compared to others of the class. It is vital to conduct researches regarding the efficacy and side effects of the medication even though it is being used as a prescription medication. This FDA approved medication seemed to be causing rhabdomyolysis. There were no impacts established between statins and rhabdomyolysis prior to this valuable study. Rhabdomyolysis is a medical condition in which rapid destruction of the skeletal muscles occurs. This is a rare condition where the muscles break down. Mild muscle pain can be a common symptom of statin consumptions. However, some people who take this medication for a prolonged period suffer severe muscle ache throughout their body. Muscle weakness and dark colored urine are other symptoms they witness. These are caused when they suffer from this health condition, a side effect of the medication.
Statin expert has played a vital role in presenting this valid information to FDA. These professionals specialize in the areas of atherosclerosis, vascular inflammation and cholesterol metabolism focus in the following: drug development process, clinical trial design, drug safety evaluation, safety review of the drugs, FDA drug labeling, etc.
FDA Consultant 