FDA on Safety of Medications
Written by Faith Anderson on September 26, 2012
COX-2 Inhibitors and Heart Attack, Stroke Side Effects
One example offered by the FDA of a potentially dangerous class of drugs is COX-2 inhibitors – anti-inflammatory medications that are designed to reduce arthritis pain while protecting the intestines and stomach. Unfortunately, as Douglas Throckmorton, M.D., deputy director of the FDA’s Center for Drug Evaluation and Research, warns, these popular medications have had unforeseen complications, including increasing a patient’s risk of stroke and heart attack side effects. In fact, two COX-2 inhibitors, Bextra and Vioxx, were recalled in 2004 and 2005, respectively, because of these side effect risks, while the FDA concluded that the benefits of another COX-2 inhibitor called Celebrex outweigh the potential risks in properly selected and informed patients.
Possible Benefits of Predictive Toxicology
The problem posed by certain medications is that some side effects are only discovered when a drug is used by a larger and more diverse population of patients than the one involved in the research that is required by the FDA prior to approval. For drug regulators, this issue demonstrates the potential benefits of a type of scientific research called predictive toxicology, which, according to senior science advisor for the FDA, Suzanne Fitzpatrick, Ph.D., involves getting “the best possible picture” of the risks associated with taking a drug before it is even tested in humans. In August 2011, the FDA released its “Strategic Plan for Regulatory Science,” which entails developing new standards, tools and approaches to assess the safety and effectiveness of FDA-regulated medications.
Revolutionary “Human on a Chip” Technology
In an effort to reach this goal, the FDA is working to create a technology called the “human on a chip,” which could allow advanced drug testing using human cells to create a miniature version of ten different organ systems that would mirror their function in a full-size human body. According to Fitzpatrick, this technology will allow researchers to test new medications safely and more accurately without having to test the drugs on animals. Along the same vein, director of the FDA’s National Center for Toxicological Research (NCTR), William Slikker, Jr., Ph.D., says that the process of testing medications is often complicated by the fact that many of the tests are not conducted on the “target species,” which are the people who will eventually be using the product. In light of these concerns, the FDA is working towards reducing or replacing animal testing with other technologies to more accurately determine the right doses and identify potential hazards, thereby making medications safer and more effective for human patients.