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Weekly Drug News Round Up - March 4, 2015

FDA Drug Safety Warning: Testosterone Heart Risks

Symptoms of a heart attack or stroke include chest pain, shortness of breath, weakness, or slurred speech Read More...

The U.S. Food and Drug Administration (FDA) is requiring manufacturers of testosterone products to update prescription labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Manufacturers must also update their labeling to clarify the that approved uses of these medications are only for men who have low testosterone levels (hypogonadism) caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. See the Data Summary section of the FDA Drug Safety Communication for additional details.

FDA Priority Review Expands Use of Opdivo to Include Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S., with an estimated 159,260 deaths in 2014 Read More...

The U.S. Food and Drug Administration (FDA) today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is already approved to treat metastatic melanoma (skin cancer). Opdivo’s efficacy in NSCLC was measured by overall survival in 272 participants, of whom 135 received Opdivo and 137 received docetaxel. On average, those who received Opdivo lived 3.2 months longer than those who received docetaxel. The most common side effects of Opdivo are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea and constipation.

Sanofi Receives FDA Approval for Basal Insulin Toujeo

Toujeo is expected to be available in the U.S. at the beginning of Q2 2015 Read More...

Long-acting insulin injections help diabetes patients control their blood sugar levels over a 24-hour period. The U.S. Food and Drug Administration has approved Sanofi’s Toujeo (insulin glargine [rDNA origin]), a once-daily long-acting basal insulin for adults with type 1 or type 2 diabetes. In the clinical trials evaluating Toujeo, all of the primary study endpoints were met by demonstrating similar blood sugar control with Toujeo as compared to Lantus. The most common adverse events (excluding hypoglycemia) reported for Toujeo included nasopharyngitis and upper respiratory tract infection.

New IUD Liletta Approved to Prevent Pregnancy

The Liletta IUD will prevent pregnancy for up to three years Read More…

Actavis and Medicines360 have announced the approval of Liletta (levonorgestrel-releasing intrauterine system). Liletta is placed in the uterus by a healthcare professional and works up to three years by continuously releasing levonorgestrel, a progestin, to prevent pregnancy. Liletta is a small, flexible plastic T-shaped system which is 32 x 32 millimeters in size. In the ACCESS IUS trial of 1,751 women ages 16 to 45 who used Liletta, the IUD was found to be safe and prevented pregnancy in 99.45 percent of women over the cumulative three-year period. Liletta is indicated for women regardless of parity (number of births) or body mass index (BMI).

Nasal Nerve Treatment Can Help With Migraines: Study

In a minimally invasive procedure, none of the 112 patients required sedation Read More...

Early findings in a study of migraine sufferers has shown that treatment with the local anesthetic lidocaine to the nerves in the back of the nasal cavity appears to offer significant relief. In the study, pre-treatment pain scores for participants averaged more than 8 on a scale of 1 to 10, with 10 being worst pain. During the session, “image-guided therapy” involved a spaghetti-sized catheter that delivered the lidocaine to nerves in both nasal passages. The day after the procedure, average migraine pain levels had dropped from 8 to 4. Pain scores reached an average of 5 at one month post-procedure.