In The News: October 2013
FDA Issues Warning Regarding Acetaminophen and Skin Reactions
Acetaminophen can cause rare but serious skin reactions, warns the U.S. Food and Drug Administration (FDA). In a recent statement, the FDA warned consumers that although uncommon, possible reactions to acetaminophen include three serious skin diseases with symptoms including rash, blisters and, in the worst case, widespread damage to the surface of the skin. According to the FDA, the skin reactions, known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP), are rare, but can be deadly. After evaluating serious skin reactions associated with acetaminophen from 1969 to 2012, the FDA identified 91 cases of SJS/TEN and 16 cases of AGEP, which resulted in 67 hospitalizations and 12 deaths. The FDA will now require a warning about the skin conditions on the labels of prescription and over-the-counter medications containing acetaminophen. Anyone who develops a rash or other skin reaction is advised to stop taking the product immediately and seek medical attention.
Bisphosphonates Show a Reasonably Safe Renal Profile
Although being associated with incidence of adverse renal events, bisphosphonates have shown to have a reasonably safe renal profile in the treatment of osteoporosis, according to recently released research. The study published in the August issue of the Journal of Bone and Mineral Research, showed the use of both oral and intravenous bisphosphonates led to no long-term effects on kidney function. The review has shown that, if used with care and in accordance with the prescribing information, these agents can be administered to patients with various degrees of renal impairment, with no long-term decline in renal function. The review found that pivotal clinical trials of oral bisphosphonates for postmenopausal osteoporosis—alendronate (Fosamax®), risedronate (Actonel®) and ibandronate (Boniva®)—show no short-term or long-term effects on renal function. Intravenous forms of the drug—ibandronate and zoledronic acid (Zometa®, Reclast®) —showed transient post-infusion increases in serum creatinine. It is important that patients who are given zoledronic acid intravenously receive the push over a 15- to 20-minute period, according to Cleveland Clinic rheumatologist Chad Deal, MD. For patients with a reduced glomerular filtration rate (GFR) of 35 to 60, it is advised that the drug be given over a 30- to 60-minute timeframe, Dr. Deal says.
Simponi® Aria™ Approved for Treatment of RA
The U.S. Food and Drug Administration (FDA) has approved the anti-tumor necrosis factor (TNF) infusible therapy, golimumab plus methotrexate (Simponi® Aria™) for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA). The drug’s recommended dosing regimen of two mg/kg is given as an intravenous infusion over a 30-minute period at weeks zero and four, then every eight weeks thereafter. Simponi® Aria™ has been an available treatment, but the FDA’s approval now allows the golimumab plus methotrexate infusible therapy to be covered under Medicare Part B.
Bone Marrow Fat May Increase Osteoporosis Risk
Excess fat in blood, muscle and the liver may increase the risk of osteoporosis, according to a study published in the July issue of Radiology. After measuring fat in more than 100 men and women aged 19 to 45 who were obese but otherwise healthy, researchers found that those with more liver and muscle fat had higher levels of fat in their bone marrow. Higher levels of bone marrow fat increase the risk of fractures, according to the study’s authors. Previous studies have suggested that obesity is protective against bone loss, but this study focused on bone marrow fat’s impact on the cells responsible for bone formation. Additional research is needed to explore the mechanisms connected with this association.