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Weekly Drug News Round Up - January 8, 2014

FDA Approves Farxiga for Treatment of Type 2 Diabetes

The FDA is requiring six post-marketing studies for Farxiga, including those evaluating risks for bladder cancer and heart toxicity Read More...

The U.S. Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) tablets to improve glycemic (sugar) control, along with diet and exercise, in adults with type 2 diabetes. Farxiga is in a newer class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors that lowers blood sugar levels by blocking glucose kidney reabsorption and increasing its excretion. Farxiga’s effectiveness was shown in 16 clinical trials involving more than 9,400 patients. Treatment with Farxiga has been studied alone or in combination with other type 2 diabetes medications, including metformin. Another SGLT2 drug, Invokana (canagliflozin) was also okayed by the FDA in March 2013.

Romosozumab: Amgen’s Investigational Osteoporosis Drug

Most osteoporosis drugs work by halting bone loss, but they don't have the ability to rebuild the skeleton Read More...

A new treatment under investigation for prevention of the bone-weakening disease osteoporosis may be up to 3 times more effective than current medications. The drug under study, romosozumab, blocks signals that prevent the body from rebuilding new bone by inhibiting the action of sclerostin, as reported by researchers in the New England Journal of Medicine. In clinical studies, romosozumab increased bone mineral density by 11.3 percent, compared with a 7.1 percent increase with teriparatide (Forteo) and a 4.1 percent increase with alendronate (Fosamax), both approved osteoporosis agents. Phase III studies with romosozumab are ongoing.

Pediatric Suicide Risk Equal Among Antidepressants: Study

Experts remind that failure to treat pediatric depression with an antidepressant is associated with suicidal behavior Read More…

A new study published this month in Pediatrics reviewed the medical records of nearly 37,000 Medicaid-enrolled, school-aged kids between 1995 and 2006. All were new users of one of six antidepressant medications: Prozac, Zoloft, Paxil, Celexa, Lexapro or Effexor. None of the antidepressants in the study appeared to have a significantly higher risk for suicide risk when compared to Prozac, the gold standard for treatment in this age group. The risk of suicide was higher for children who were taking multiple antidepressants at the same time, but experts state this reflects the severity of their depression and not any increased threat from the medications.

FDA: Do Not Exceed Doses of Sodium Phosphate Laxatives

Use caution with these products in children 5 years and younger; the rectal form should never be given to children under 2 years Read More...

Over-the-counter (OTC) sodium phosphate drug products include oral saline solutions and enemas used rectally to treat constipation. The U.S. Food and Drug Administration (FDA) is warning that using more than one dose in 24 hours of OTC sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day. Consumers who use OTC products should always read the Drug Facts label to determine dosing.

A New Year's Resolution? Your Guide to Kicking the Habit

A multitude of options exist for smokers trying to kick the habit, including medications, hypnosis and even social support Read More…

It’s 2014, and that means new goals. Several options are now available for smokers who are trying to quit the tobacco habit. Some have side effects, but the benefits of quitting probably exceed the risks. Current options include nicotine replacement with products like Nicoderm CQ, medications like Zyban and Chantix, and even hypnosis and acupuncture, which are not well studied but could be considered as an alternative. The benefit of social support, for example, the help-line 1-800-QuitNow, should not be overlooked. Smoking cessation experts have yet to give e-cigarettes - a device that uses heat to turn nicotine into a vapor that's inhaled - the green light, but their use is increasing.