Archive for the ‘Medicine’ Category

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.


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.

Understanding Sleep Disorders

September 20, 2012 Leave a comment

By Steve Dingman

Sleep disorders can be disheartening and dangerous to sufferers. After a night of insomnia or sleep that is not restful, an individual with a sleep disorder may be distracted at work or drowsy behind the wheel, both of which can lead to deadly accidents.

Research suggests that as many as 70 million Americans suffer from sleep disorders, and as many as 40 million Americans experience chronic disturbances to their sleep. Because of the impact this type of disorder can have on a person’s life and well-being, researchers have devoted much effort to understanding what causes sleep disorders.

A variety of factors are often to blame: genetics, environment, and medications have all been targeted as sleep disorder culprits. Another common cause is working a night shift, which can throw off a person’s natural circadian rhythms. Even fairly ordinary events, such as stress at work or moving, can lead to troubled sleep. In some cases, sleep disturbances are caused by a malfunction in one part of the brain, as in one type of sleep apnea.

Individuals who experience sleep disorders that interfere with normal daily activities should seek medical attention.

About the Author

Steve Dingman serves as Drug Safety Physician with UCB, Inc., in North Carolina.

The Role of Medical Product Labels, By Steve Dingman

Anyone who has set foot in a supermarket is familiar with the practice of food labeling. The Food and Drug Administration (FDA) maintains strict standards for what must and what cannot appear on food labels and packaging.

The FDA also sets out guidelines for medicine and medical equipment. In the medical field, labels are at least as important as they are in the grocery store. In an urgent surgery situation, a nurse or doctor may need to know at a glance, based on a product’s label, whether that product can save a patient’s life.

Just as the FDA routinely issues new guidelines about what can and cannot appear on food labels, the organization regularly updates its recommendations for medical labels. FDA guidelines for medical labels are intended to promote clear and concise communication of information. Failure to follow these guidelines could lead to tragic consequences for consumers—and hefty fines for manufacturers. Despite existing guidelines, however, some in the medical industry believe that labels could be made clearer and more informative through the use of color coding, larger fonts, and smaller company logos on packaging.

About the Author

In his role as Drug Safety Physician with UCB, Inc., in Raleigh, North Carolina, Steve Dingman provides recommendations for updates to product labels for various medical products.

An Early History of Sleep Studies

German physician Hans Berger invented the early EEG machine that in 1924 was used to document the first record of human brain activity. Over the next few years, he published his findings, including brain changes during sleep, and set off new areas of scientific study.

Scientists, inventors, and physicians built on Berger’s initial studies and by the 1950s, two University of Chicago researchers, Nathaniel Kleitman and his graduate student Eugene Aserinsky, made revolutionary discoveries that opened the floodgates for the scientific study of sleep. The two, in fact, were the first to recognize rapid eye movement or REM, the stage of sleep most associated with dreaming and with recordable brain activity similar to periods of wakefulness.

Kleitman, along with a growing community of colleagues, continued his sleep research to eventually conclude that the time of sleep stages and their lengths vary for an individual from night to night and is completely unique to the individual.

Steve Dingman, MD, is a Drug Safety Physician at the pharmaceutical company UCB, Inc., in Raleigh, North Carolina. Dr. Dingman works with the company’s Clinical Sub Team and Product Lifecycle Team for sleep and movement disorders.