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Weekly Drug News Round Up - February 26, 2014

Acetaminophen Use in Pregnancy Linked to ADHD in Kids: Study

This study did not establish a cause-and-effect relationship; follow-up research is needed due to the major public health impact Read More...

Acetaminophen (Tylenol) has long been recommended as the pain and fever reliever of choice in pregnancy. However, a new long-term study published in JAMA Pediatrics suggests pregnant women who take acetaminophen (Tylenol) repeatedly and over a prolonged period might increase the risk of their child being diagnosed with attention deficit-hyperactivity disorder (ADHD). More than 64,000 children and mothers were involved in the study. Results showed that children whose mothers took acetaminophen had a 37 percent higher risk of receiving a diagnosis of hyperkinetic disorder, a severe form of ADHD. Children were also 29 percent more likely to use ADHD medication and 13 percent more likely to exhibit ADHD-like symptoms.

FDA Approves Amylin’s Myalept for Rare Metabolic Disease

Common side effects include low blood sugar, headache, decreased weight, and abdominal pain Read More...

The U.S. Food and Drug Administration (FDA) has approved the orphan drug Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital or acquired generalized lipodystrophy. Patients with generalized lipodystrophy often develop severe insulin resistance, diabetes mellitus, or high levels of triglycerides (hypertriglyceridemia) that can lead to pancreas inflammation. In clinical trials, Myalept led to reductions in HbA1c (a measure of blood sugar control), fasting glucose, and triglycerides. Due to the risk of neutralizing antibodies and lymphoma, Myalept is only available through the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program.

FDA Approves A Lower Dose Indomethacin: Iroko’s Tivorbex

The submicron particles in Tivorbex are roughly 20 times smaller than their original size Read More...

The U.S. Food and Drug Administration (FDA) has approved the 20 mg and 40 mg strengths of Tivorbex (indomethacin), a nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate acute pain in adults. Tivorbex capsules were approved at dosage strengths that are 20 percent lower than currently marketed indomethacin and contain submicron particles that provide an increased surface area, leading to faster dissolution. Lower doses may help to prevent serious NSAID side effects such as heart attacks, strokes, stomach bleeds, and kidney damage. The American College of Rheumatology recommends that NSAIDs be used at the lowest effective dose for the shortest possible duration.

Updated: Guidelines for Stroke Prevention in Nonvalvular Atrial Fibrillation

Irregular heartbeat can cause blood to remain in the heart's chambers, form a clot, and then travel to the brain leading to a stroke Read More...

Blood thinners are recommended for all patients with irregular heartbeats (atrial fibrillation), especially with a history of stroke or mini-stroke, according to an updated guideline published by the American Academy of Neurology (AAN). Treatment should be individualized; however, the elderly, those with mild dementia, or those at moderate risk of falls can now be included in treatment groups. Several new blood thinners, including dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis) have been approved since the last guideline in 1998. The newer oral drugs are similar or better than warfarin, less likely to lead to bleeding in the brain, and don’t require regular blood tests.

Blood Pressure Meds and Risk of Falls in Seniors: Study

The risk was higher among those who had a serious injury from a previous fall Read More...

A study published in JAMA Internal Medicine found an association between the use of blood pressure medications and a higher risk for falls and broken bones in the elderly. In the study, no particular drug class seemed to be more or less risky, as many blood pressure medications can lead to side effects like dizziness or imbalance. In the study of roughly 5,000 seniors over the age of 70, 446 patients (9 percent) suffered serious injuries from falls. Experts state the results are inconclusive, as high blood pressure itself may also be linked with falls.