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Posts Tagged ‘Dr. Steve Dingman’

Dr. Steve Dingman: FDA Comments on Insomnia Medication’s Safety

In his role as drug safety physician, Dr. Steve Dingman assists UBC, Inc., with global clinical safety matters. Dr. Steve Dingman works with the company’s clinical sub and product lifecycle teams. He is a graduate of the University of North Carolina at Chapel Hill.

The U.S. Food and Drug Administration (FDA) recently determined that suvorexant, an experimental insomnia medication, is safe only at lower doses than those originally proposed. The drug was designed to treat insomnia by inhibiting wakefulness.

The pharmaceutical company that created the drug developed the medication to compete with common sleep aids like Lunesta and Ambien. If approved, analysts predict that suvorexant will bring revenues in the hundreds of millions of dollars.

Suvorexant works by interfering with orexin, a neurotransmitter that causes wakeful and aroused states. By blocking the neurotransmitter, the drug treats insomnia without the next-morning side effects commonly caused by current insomnia medications on the market.

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A Look at Pharmacovigilance

Possessing more than two decades of experience in the medical field, Dr. Steve Dingman has obtained expertise in organic chemistry, investigational drugs, pharmaceutical research, US Food and Drug Administration filings, and other areas. Dr. Dingman serves as drug safety physician in the Global Clinical Safety and Pharmacovigilance Department of UCB, Inc.

Pharmacovigilance refers to the field concerned with the adverse effects of pharmaceuticals, biologicals, and herbal remedies. Those who practice the science identify and evaluate the negative impact of drugs before and after they reach the market. Among their responsibilities are drug monitoring, adverse drug reaction reporting, and postmarketing product surveillance. Focused on patient safety, this area also involves conducting public health programs that inform people about the risks and benefits of medicines.

The World Health Organization (WHO) established this branch in the 1960s as a result of thalidomide, a sedative that caused birth defects in infants. Initially responsible for creating the Programme for International Drug Monitoring, WHO later formed the more inclusive Collaborating Centre for International Drug Monitoring. Since WHO encouraged each nation to implement its own pharmacovigilance initiatives, more than 130 countries have joined the program.