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Weekly Drug News Round Up - November 26, 2014

Purdue Pharma’s Abuse-Deterrent Hysingla ER Approved for Pain

Hysingla ER should not be used for as-needed pain relief Read More...

The U.S. Food and Drug Administration (FDA) has approved Hysingla ER (hydrocodone bitartrate), an acetaminophen-free, extended-release (ER) opioid for severe pain requiring daily, long-term treatment and for which no alternatives exist. Hysingla ER abuse-deterrent properties may reduce, but not totally prevent, abuse of the drug. The tablet forms a thick gel and cannot be easily prepared for injection, and is difficult to crush, break or dissolve. The most common side effects of Hysingla ER are constipation, nausea, fatigue, and dizziness. Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), another of Purdue Pharma’s abuse-deterrent opioids, was also approved in July.

Valeant’s Onexton Wins Approval for Acne Vulgaris

Acne vulgaris is a common skin disorder that affects 40 to 50 million people in the United States Read More...

Onexton (benzoyl peroxide and clindamycin phosphate) is an antimicrobial and lincosamide antibacterial combination for the topical treatment of acne vulgaris. The U.S. Food and Drug Administration has approved Onexton for the once-daily treatment of comedonal (noninflammatory) and inflammatory acne in patients 12 years and older. The most common treatment-emergent and treatment-related adverse events were: burning sensation (0.4%), dermatitis contact (0.4%), pruritus (0.4%) and rash (0.4%). In trials, no patient discontinued use due to any adverse event. Valeant has already successfully launched Jublia (efinaconazole), Retin-A Micro (tretinoin gel) microsphere, and Luzu (luliconazole). Onexton will launch in early 2015.

Fatal and Rare Brain Infection Reported With Tecfidera

Information describing this case of PML is being added to the Tecfidera drug label Read More...

The U.S. Food and Drug Administration (FDA) is warning that a patient with multiple sclerosis (MS) who was being treated with Biogen Idec’s Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. Patients taking Tecfidera should contact their healthcare professionals right away if they experience symptoms that concern them, such as weakness, trouble using their arms or legs, or changes to thinking, eyesight, strength or balance. Health care professionals should stop Tecfidera if PML is suspected.

Most Seniors Eligible for Statins: Study

Cholesterol guidelines released late last year target people most likely to benefit from taking statins Read More...

The latest cholesterol guidelines recommend statins for people with heart disease, diabetes or high cholesterol, but also recommend the drugs for people who don't have these conditions but do have a higher than 7.5 percent risk of heart attack or stroke in the next 10 years based on a risk calculator. This week, a research letter published in JAMA Internal Medicine found that 97 percent of 6,000 Americans aged 66 to 75 were eligible for statin therapy, including all men in the study. Evaluating even older patients, the study found that 70 percent of those ages 66 to 90 were eligible for statins, like rosuvastatin (Crestor) and atorvastatin (Lipitor).

No Link Between Acetaminophen Use in Pregnancy and Asthma: Study

Researchers reviewed 11 studies looking at the link between acetaminophen use and asthma Read More…

Previous studies have suggested that the use of acetaminophen (Tylenol) during pregnancy or early childhood may be associated with the development of asthma. However, new research published in BMJ suggests this may not be true. In fact, the research points to infant respiratory infections as a possible culprit in childhood asthma development. Authors state that evidence does not support changing current recommendations about the use of acetaminophen in children. However, parents should always be cautious with dosing; excessive acetaminophen doses can lead to liver toxicity.