Department: Medication Update
New antibiotic approved to treat community-acquired bacterial pneumonia
Lefamulin (Xenleta) has been approved to treat adults with community-acquired bacterial pneumonia (CABP). Lefamulin's safety and efficacy, taken orally or via I.V., was demonstrated in two clinical trials involving over 1,200 patients with CABP. The trial showed that patients treated with lefamulin had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.
The most common adverse reactions reported in patients taking lefamulin included diarrhea, nausea, injection-site reactions, elevated liver enzymes, and vomiting. Lefamulin has the potential to prolong the QT interval; therefore, patients with prolonged QT intervals, arrhythmias, and those taking antiarrhythmic agents should avoid taking lefamulin.
New add-on drug for “off” episodes of Parkinson Disease
The FDA approved istradefylline (Nourianz) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson disease (PD) experiencing “off” episodes when current medications are not working well and there is an increase in PD symptoms.
Istradefylline's effectiveness in treating “off” episodes in PD patients who are already being treated with levodopa/carbidopa was demonstrated in four 12-week placebo-controlled clinical studies conducted in 1,143 participants. In all four studies, patients treated with istradefylline experienced a statistically significant decrease from baseline in daily “off” time compared with patients receiving a placebo.
The most common adverse reactions associated with istradefylline included dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia.
FDA warns of rare, serious liver injury and failure with certain hepatitis C treatments
The FDA has received reports that the use of glecaprevir/pibrentasvir (Mavyret), elbasvir/grazoprevir (Zepatier), or sofosbuvir/velpatasvir/voxilaprevir (Vosevi) to treat chronic hepatitis C virus (HCV) in patients with moderate-to-severe liver impairment has resulted in rare cases of worsening liver function or liver failure. The agency identified 63 cases of liver decompensation with these drug regimens; some cases led to liver failure and death. In most patients, symptoms resolved or new-onset worsening of liver function improved after stopping the medicine. These medications have been widely used and are safe and effective in patients with no or mild liver impairment.
The FDA notes that these medications are not indicated for use in patients with moderate-to-severe liver impairment; most of these patients had moderate-to-severe liver failure and should not have been prescribed these medications.
Healthcare providers should continue to prescribe glecaprevir/pibrentasvir, elbasvir/grazoprevir, or sofosbuvir/velpatasvir/voxilaprevir as indicated in appropriate patients (as described in product labeling). Glecaprevir/pibrentasvir and elbasvir/grazoprevir should not be prescribed in patients with any history of prior hepatic decompensation; sofosbuvir/velpatasvir/voxilaprevir is indicated for patients who have previously failed certain other HCV treatments and is not recommended for patients with any history of hepatic decompensation unless benefits of treatment outweigh the risk of liver injury, liver failure, or death.
Increased risk of clots, death with higher dose of Xeljanz, Xeljanz XR
The FDA has added a boxed warning to the labeling of tofacitinib (Xeljanz, Xeljanz XR) concerning an increased risk for pulmonary embolism and death with the 10 mg twice-daily dose of the drug, which is used in patients with ulcerative colitis. The FDA states that tofacitinib use for ulcerative colitis should be limited to patients who have failed or do not tolerate tumor necrosis factor blockers. In addition, tofacitinib use should be avoided in patients who may have a higher risk of thrombosis.
The agency is taking this action after reviewing data from an ongoing safety trial of tofacitinib in patients with rheumatoid arthritis (RA), which examined a lower (5 mg dose, the current approved dose for RA) and this higher dose of tofacitinib.
Healthcare providers should discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis.