New Generation Biological Drugs Saftey Testing
New generation biological drugs have at times experienced safety concerns, a few companies have even issued warnings a short time after the product entered the market. More thorough testing before approval by government agencies would prevent that scenario from happening.
That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.
Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007.
Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs.
The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.
The drugs are known as biologicals because theyre made from living material and they typically affect the bodys disease-fighting immune system. Many relieve severe symptoms by suppressing that system.
Its that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert. These can include brain and fungal infections and cancer.
Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows thats not necessarily true.
“They have an important role,” Bennett said. “Theyre really the next generation of pharmaceuticals.”
He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.
Among the drugs under examination are Genentech Inc.s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.
The study appears in Wednesdays Journal of the American Medical Association.
The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.
But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.
“If most issues are discovered within the first few years, then the system is working,” Giezen said.
Bennett says its unreasonable to think that the studied drugs safety issues should have been discovered before they were marketed. Thats because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.
Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices.
Source: mibax