Although you may hear about the dangers of vitamins and herbs, prescription medications have their fair share of adverse reactions and medication safety issues. This is important because about 25 percent of all new drugs are biologicals, and with nearly 25 percent of all biologic drugs experiencing at least one safety-related issue, this can seriously affect consumers who use them. Moreover, the use of biological drugs is increasing by leaps and bounds, and, in fact, according to URCH Publishing, biological sales have increased by at least “20% in 2007.”
Biologicals are a new class of medicines. The first biological in America was approved in 1982, and it was recombinant insulin. Although all drugs carry risks, biologicals carry specific risks, particularly for the immune system. That is because they are “vaccines, cultures, and other preparations” created from living organisms, such as antibodies, enzymes, or hormones and designed to diagnose, immunize, and treat illnesses and diseases. Besides vaccines, biologicals are also found in blood products, cell regulators, and other related vitro diagnostic tests.
While biologicals may play an important role in health, according to a recently released study published in the Journal of the American Medical Association (JAMA), of the 174 biologicals approved between 1995 and 2007, 41 medications received some sort of “safety-related regulatory action,” which amounts to a whooping 23.6 percent being affected. Of the 41 medications, 82 regulatory actions occurred: 46 “dear health care professional” letters, 17 direct health care professional communications, and 19 black box warnings, which are warnings that state a medication poses serious side effects, but may not be serious enough to take the medication off the market.
Of the 19 black box warnings issued, over 10 percent were used to treat Chrohn’s disease, cancer, and rheumatoid arthritis. A few of the biologicals that received black box warnings include Enbrel (etanercept), Remicade (infliximab), and Avastin (bevacizumab). Additionally, biologicals released for the first time showed a much greater risk of receiving a safety-related regulatory action than later approved products, and, 70.7 percent of the actions were taken within the first five years of the biological hitting the market place.
Because of the high incidence of biological medication safety issues, researchers who conducted the study suggest health care professionals select patients appropriately. In addition, researchers recommend other options be tried first, and, if proven unacceptable, patients then be given biological medications and closely monitored to avoid adverse reactions. If you’re interested in learning how other people rate their experience with a prescription, read How Does Your Prescription Stack Up?