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FDA News Briefs for Tuesday, February 26, 2019

February 26, 2019

These Food and Drug Administration (FDA) developments came in recently:


FDA Safety Alert: Risk of Blood Clots Associated with Tofacitinib

The FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs or death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR; Pfizer Inc.) was used in patients with rheumatoid arthritis (RA). The FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.  More Information.


Expanded FDA Approval for Lonsurf

The FDA has granted expanded approval for Lonsurf (Taiho Oncology). Lonsurf is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, now indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Lonsurf was previously approved for the treatment of adult patients with metastatic colorectal cancer who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. More Information.


Another Losartan Recall

Macleods Pharmaceuticals Limited is voluntarily recalling 1 lot of losartan potassium/hydrochlorothiazide combination tablets due to the detection of trace amounts of an unexpected impurity (N-nitrosodiethylamine) found in the finished product. A list of other recently recalled losartan-containing products has been updated by the FDA. More Information.