The Food and Drug Administration (FDA) has notified healthcare professionals that it is evaluating clinical trial data suggesting that patients taking Stalevo™ (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events compared with those taking carbidopa/levodopa (sold as the combination product, Sinemet™).
Data published in the Archives of Surgery suggest that during trauma surgery, reinfusing a patient’s own shed blood—in addition to donor transfusions—is a safe, effective, and cost-saving alternative to donor (allogeneic) transfusions alone. However, the study was small and the procedure is likely to require additional resources above and beyond those currently available in smaller facilities.
An Advisory Committee of the Food and Drug Administration (FDA) has narrowly voted (8 to 6) in favor of expanding the indications for duloxetine HCl (Cymbalta™) to include chronic knee and low back pain. The Committee rejected (4 to 9, 1 abstention) the proposed indication for chronic pain due to osteoarthritis. Duloxetine is currently approved for major depressive and general anxiety disorders, the management of pain from diabetic peripheral neuropathy, and fibromyalgia. Although the FDA is not required to follow the recommendations of its committees in approving new medications or indications, it often follows the recommendations.
According to data from two different phase 3 studies, insertion of a gentamicin-collagen sponge at the time of surgical closure following either colorectal or cardiac surgery did not reduce the rate of surgical site infections (SSI) when compared with placebo. In patients who had undergone colorectal surgery, insertion of the sponge resulted in significantly more surgical-site infections. The results from the cardiac surgery trial dispute data from a large 2005 Swedish trial suggesting that the sponge reduced SSI by 50% in patients who underwent cardiac surgery.
The Food and Drug Administration (FDA) has issued its first-ever proposal to withdraw approval of an approved drug because required postapproval studies that verify the clinical benefit of the drug have not been done.
A new study published in the Archives of Internal Medicine suggests that many men diagnosed with prostate cancer appear to under undergo overly aggressive therapy, even if they have a low prostate-specific antigen (PSA) level and low-risk disease.
The Food and Drug Administration (FDA) has announced a Class I recall of several St. Jude Medical 6 French (Fr) Engage Introducer devices because its shaft or hub assembly may break and cause potentially fatal bleeding. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The Food and Drug Administration (FDA) has issued a safety warning that lamotrigine (Lamictal™), a medication commonly used for seizures in children 2 years of age and older, and bipolar disorder in adults, can cause aseptic meningitis. Lamictal is also sold as an orally disintegrating tablet (Lamictal ODT), a chewable, dispersible tablet (Lamictal CD), and as an extended release product (Lamictal XR).
The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have announced the release of revised classification criteria for rheumatoid arthritis (RA). Classification criteria are the standard and accepted means by which researchers define people as having or not having a given disease, helping to standardize recruitment into clinical trials and other research studies. This allows for the study of treatments for RA at much earlier stages of the disease—before joint damage occurs—ultimately leading to better patient outcomes. Although not intended as criteria for diagnosis in clinical practice, with some additional research, classification criteria may be modified and adopted for such use.
The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have announced the release of revised classification criteria for rheumatoid arthritis (RA). Classification criteria are the standard and accepted means by which researchers define people as having or not having a given disease, helping to standardize recruitment into clinical trials and other research studies. This allows for the study of treatments for RA at much earlier stages of the disease—before joint damage occurs—ultimately leading to better patient outcomes. Although not intended as criteria for diagnosis in clinical practice, with some additional research, classification criteria may be modified and adopted for such use.
