News: Alerts

New warning draws attention to the increased risk of blood clots and death associated with higher doses of tofacitinib.

Altaire issued the retail level recall over quality concerns at their manufacturing facility.

FDA issued a warning about the risk of transmitting multidrug resistant organisms (MRDOs) via fecal microbiota transplant (FMT).

Heritage Pharmaceuticals issued a voluntary recall of specific lots of amikacin sulfate and prochlorperazine edisylate injections on May 28, 2019, due to possible lack of sterility.

Use of certain insomnia medications has caused complex sleep behaviors resulting in serious harm or death.

Sudden discontinuation or rapid dose reduction of prescription opioids in patients who are physically dependent on these medications can cause serious harm including psychological distress, serious withdrawal symptoms, suicide, and...

Prinston Pharmaceutical Inc. recalled tablets of irbesartan and irbesartan co-formulated with hydrochlorothiazide. The recall affects 1 lot of irbesartan and 7 lots of irbesartan-hydrochlorothiazide. One of the raw ingredients, irbesartan...

More manufacturers have recently recalled their valsartan products.

FDA issued a warning that tofacitinib (Xeljanz, Xeljanz XR) may increase the risk of pulmonary embolism in patients with rheumatoid arthritis.

FDA is strengthening warnings in the febuxostat (Uloric) product labeling and has added a Medication Guide requirement because of an increased risk of cardiovascular death and all-cause mortality.

Apotex Corp. voluntarily recalled drospirenone and ethinyl estradiol tablets.

The FDA is notifying the public that Dr. Reddy’s Laboratories Ltd. is voluntarily recalling levetiracetam injection bags due to mislabeling.

Fluoroquinolones administered orally or intravenously may increase the risk of ruptures or tears in the main artery of the body, also known as the aorta, in certain patients.

Sandoz Inc. voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide.

Symptoms of differentiation syndrome are not being recognized in patients receiving enasidenib for the treatment of acute myeloid leukemia (AML).