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Weekly Drug News Round Up - July 8, 2015

FDA Approves Entresto for Heart Failure Six Weeks Ahead of Schedule

Analysts call Entresto a megablockbuster and predict the drug could peak at $6 to $8 billion per year Read More…

On July 7, the U.S. Food and Drug Administration (FDA) approved Novartis’ Entresto, a twice-daily oral Angiotensin Receptor Neprilysin Inhibitor (ARNI) indicated to reduce the risk of death and hospitalization in patients with chronic heart failure. Entresto contains a combination of sacubitril, a first-in-class neprilysin inhibitor, and valsartan, an angiotensin II antagonist already FDA approved as Diovan. In the PARADIGM-HF Phase III study, Entresto was superior to ACE inhibitor enalapril. Entresto reduced the risk of death from cardiovascular causes and heart failure hospitalization by 20% and 21%, respectively, and reduced the risk of all-cause mortality by 16%. Common side effects include low blood pressure, high blood potassium levels, and poor kidney function.

Orkambi Combo Approved for Cystic Fibrosis

Cystic fibrosis (CF) is a rare genetic disease that leads to a deadly buildup of thick mucus in the lungs and other organs Read More...

The U.S. Food and Drug Administration (FDA) has approved Orkambi (ivacaftor and lumacaftor), a combination treatment for the underlying cause of cystic fibrosis (CF) in patients 12 years and older with two copies of the F508del mutation in their CFTR gene, which accounts for about half of all CF cases in the U.S. Orkambi contains ivacaftor (Kalydeco), already FDA approved to treat a smaller subset of CF patients with different gene mutations. Orkambi is taken as a dose of two tablets every 12 hours (morning and evening) with fat-containing foods. Common side effects include shortness of breath, upper respiratory tract infection, and stomach symptoms like nausea, diarrhea, or gas.

FDA Approves Long-Acting Tuxarin ER

In 2013, roughly 13 million prescriptions were written for codeine-based cough/cold products Read More...

Tuxarin ER is a newly approved long-acting prescription cough and cold combination product containing codeine, a narcotic cough suppressant, and chlorpheniramine, an antihistamine, for patients 18 and older. It is available as an oral solid given twice a day, instead of as a liquid. Codeine decreases the urge to cough by working in the brain to suppress the cough reflex. Tuxarin ER is scheduled as DEA C-III narcotic. In 2014, the DEA reclassified hydrocodone-containing products, including the popular long-acting hydrocodone-chlorpheniramine product Tussionex, as a schedule II product, making access more restrictive.

FDA Warns of Possible Counterfeit Diazepam

The counterfeit tablets are light yellow, with a score across the middle on one side, and bear the letters AGOG on the other side Read More...

This week, the FDA warned consumers of another possible counterfeit scam. The World Health Organization (WHO) has reported 700 adverse events from patients in Central Africa taking mislabeled diazepam (Valium) that was actually the anti-psychotic drug, haloperidol (Haldol). The patients who mistakenly took haloperidol suffered side effects such as acute contractions of the muscles of the face, neck and tongue (dystonia). It has not been confirmed that the counterfeit diazepam in Africa was purchased online and FDA has no confirmed reports in the U.S. Consumers should not purchase medications online; however, FDA advises consumers who have purchased diazepam online to check if the pills they received are authentic.

Anti-Vaccine Trend May Have Parents Refusing Newborn Vitamin K Shot

Vitamin K occurs naturally in many foods, like spinach and kale and is even made in our own bodies Read More...

As reported in the Journal of Emergency Medicine, some parents are shunning the vitamin K shot routinely given to newborns at the hospital. Vitamin K is needed for normal blood clotting, and infants are not yet able to produce the vitamin naturally in their gut. Foregoing vitamin K in infants can lead to anemia, and dangerous bleeding, even in the brain. Why is this being seen? Vaccine myths, confusion, and miscommunication may be the main culprits. According to experts, the vitamin K shot (which is not a vaccine) is safe, cheap, and effective, and there’s no reason to refuse it; doing so could seriously jeopardize your newborn’s health.

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