Search results for "FDA update"


 
Results 21 - 30 of about 55 for "FDA update".

Metformin solution recalled due to contamination

Two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL, were recalled due to fungal contamination, the FDA said. ... Sun Pharmaceutical Industries, Inc., has recalled two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL
December 2017

Saxagliptin under analysis for heart failure risk

The FDA has requested clinical trial data on saxagliptin (Onglyza and Kombiglyze XR) to investigate a possible increase in heart failure in patients taking the drug. ... The manufacturer is expected to submit the data to the FDA by early March 2014,
February 2014

Abbot FreeStyle Insulinx meters recalled

The Abbott FreeStyle Insulinx blood glucose meters were recently recalled because at extremely high blood glucose levels of 1,024 mg/dL and above, the meters will display and store in memory an incorrect test result that is 1,024 mg/dL below the
July 2013

New daily injection approved for adults with type 2 diabetes

Lixisenatide (Adlyxin), a once-daily injection, was approved by the FDA on July 28 to improve glycemic control in adults with type 2 diabetes. ... In 10 trials of 5, 400 patients, the glucagon-like peptide 1 receptor agonist improved HbA1c levels, both
August 2016

New weight loss drug approved

Lorcaserin hydrochloride (Belviq) was recently approved by the FDA for chronic weight management in adults. ... Lorcaserin hydrochloride (Belviq) was recently approved by the FDA for chronic weight management in adults with a body mass index (BMI) of 30
September 2012

Safety alert and advice on CT scanning in patients with insulin pumps

The presence of an insulin pump should not preclude an appropriate and medically indicated CT scan, the FDA said. ... Clinicians should then communicate this information to the facility performing the scan, the FDA said.
April 2016

New labels warn against sharing multi-dose insulin pens

In an effort to reduce the risk of infection spread, the FDA recently required additional label warnings about sharing of multi-dose diabetes pen devices, which are intended for single patient ... Insulin pens and pens for other injectable diabetes
March 2015

New warnings for fluoroquinolones about risk of hypoglycemic coma

The FDA is requiring safety labeling changes for fluoroquinolones to strengthen warnings that the antibiotics may cause significant decreases in blood glucose levels, as well as certain mental health side effects, ... The new label changes will add an
August 2018

New weight loss device approved

A new balloon device (the ReShape Dual Balloon) was recently approved by the FDA to treat obesity without invasive surgery. ... Six months after removal, treated patients had kept off an average of 9.9 pounds, according to an FDA press release.
August 2015

Inhaled insulin approved

Afrezza, a rapid-acting, inhaled human insulin, was recently approved by the FDA to treat diabetes in adults. ... The most common adverse reactions in trials were hypoglycemia, cough, and throat pain or irritation, according to an FDA.
July 2014

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