FDA reviewed a meta-analysis of randomized clinical trials of cardiovascular and upper gastrointestinal events with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration of the Clinical Trial Service and Epidemiological Studies Units at Oxford University. 2 We also reviewed observational studies and other scientific publications in the medical literature. 1 The findings of these studies were discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014 (for complete safety reviews, background information, and minutes of this meeting, click here ).
Endometriosis implants are most commonly found on the ovaries, the Fallopian tubes, outer surfaces of the uterus or intestines, and on the surface lining of the pelvic cavity. They also can be found in the vagina, cervix, and bladder. Endometriosis may not produce any symptoms, but when it does the most common symptom is pelvic pain that worsens just prior to menstruation and improves at the end of the menstrual period. Other symptoms of endometriosis include pain during sex, pain with pelvic examinations, cramping or pain during bowel movements or urination, and infertility.
NSAIDs have anti-inflammatory (reduce inflammation), analgesic (relieve pain) and antipyretic (lower temperature) effects. Although different NSAIDs have different structures, they all work by blocking cyclooxygenase (COX) enzymes. There are two main types of COX enzymes: COX-1 and COX-2. Both types produce prostaglandins; however, the main function of COX-1 enzymes is to produce baseline levels of prostaglandins that activate platelets and protect the lining of the gastrointestinal tract, whereas COX-2 enzymes are responsible for releasing prostaglandins after infection or injury. Prostaglandins have a number of different effects, one of which is to regulate inflammation. Most NSAIDs inhibit both enzymes, although a few are available that mainly inhibit COX-2. The pain-relieving and anti-inflammatory effects of NSAIDs are mainly due to inhibition of COX-2, and their unwanted side effects are largely due to inhibition of COX-1.