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Weekly Drug News Round-Up: April 5, 2017

Austedo From Teva Gains Approval for Huntington’s Chorea

Austedo is expected to be available in the U.S. by April 24 Read More...

Huntington’s disease is a rare, hereditary, and fatal disorder of the nerve cells in the brain. Huntington’s chorea results in involuntary, random and sudden, twisting or writhing bodily movements, and occurs in 90% of patients. This week, the FDA approved Teva's Austedo (deutetrabenazine), a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for Huntington’s chorea. In Phase III studies, average scores for patients in the Austedo group improved by 4.4 units compared to 1.9 units in the placebo group at week 9 and 12; the treatment effect of -2.5 units was statistically significant (p<0.0001). The most common adverse reactions were somnolence, diarrhea, dry mouth, and fatigue.

EpiPen Recalled Due to Possible Device Failure

Patients, customers and distributors should refer to Mylan.com/EpiPenRecall for instructions Read More...

Select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr Auto-Injectors have been recalled by the manufacturer due to reports of failure of the device to activate. Failure to activate would prevent the ability to deliver the life-saving medication during an anaphylactic reaction, a severe allergy which can occur due to foods, insects, and even medications. Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.

Quinolone Antibiotic Eardrops Linked With Eardrum Perforation

Multiple studies have also linked oral quinolone antibiotics with tendon ruptures Read More...

A study from the Department of Otolaryngology at the University of Florida has found that children who receive quinolone eardrops like ciprofloxacin otic (Cipro) or ofloxacin otic (Floxin) after ear tube insertion surgery were 60% more likely to suffer eardrum perforations than those who received neomycin ear drops. In the new study, researchers tracked data on roughly 100,000 children who underwent ear tube surgery. The researchers then compared postoperative eardrum perforation rates after kids were given either the quinolone or neomycin drops. The study couldn't prove cause-and-effect, and other experts remind that neomycin ear drops can have detrimental side effects on the hearing nerve.

Whooping Cough Vaccine During Pregnancy Protects Baby Early On

Vaccinating pregnant women with Tdap can help protect their baby in the first two months before their vaccine Read More...

The Tdap vaccine for tetanus, diphtheria and pertussis ("whooping cough") is recommended for pregnant women by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP). The vaccine can be given at any time during pregnancy, preferably between 27 and 36 weeks' gestation. In a new study published in Pediatrics, Kaiser Permanente researchers looked at 149,000 infants born in California between 2006 and 2015. Babies whose moms got the Tdap shot during pregnancy had a 91 percent lower risk of whooping cough during the first two months of life and a 69 percent lower risk of whooping cough in their first year of life.

Long-Term Antibiotic Use and Colon Cancer Risk: Study

More evidence mounts that gut bacteria -- the microbiome -- may be important in human health Read More...

Researchers from Harvard have published information to suggest bacterial changes in the gut due to long-term use of antibiotics may up the odds for polyps and colon cancer. Experts collected data on more than 16,600 women 60 years and older who took part in the Nurses Health Study. The women, who had had at least one colonoscopy between 2004 and 2010 provided a history of antibiotic use between ages 20 and 59. Nearly 1,200 precancerous polyps in the colon were found during that time. Use of antibiotics within the previous four years wasn't associated with a heightened risk of polyps, but long-term use in the past was linked.

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