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Weekly Drug News Round Up - June 24, 2015

FDA Medwatch: Daytrana Patch May Lead to Permanent Skin Color Changes

Patients should not stop using the Daytrana patch without first talking to their health care provider Read More...

FDA is warning that permanent loss of skin color, known as chemical leukoderma, may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not physically harmful but is thought to be irreversible, which may cause emotional distress. FDA recommends that healthcare professionals consider alternative ADHD treatments for patients who experience these skin color changes. Patients or caregivers should watch for skin color changes and contact their provider immediately.

FDA Approves Antiplatelet Agent Kengreal

The overall occurrence of serious bleeding was low but more common with Kengreal than with clopidogrel Read More...

The U.S. Food and Drug Administration has approved The Medicines Company’s Kengreal (cangrelor), an intravenous blood thinner (P2Y12 platelet inhibitor) used in patients undergoing Percutaneous Coronary Intervention (PCI) to reduce the risk of thrombotic events, like heart attack or stent thrombosis, during the procedure. PCI is more commonly known as a coronary (heart) angioplasty. In a clinical trial that compared Kengreal to Plavix (clopidogrel), Kengreal significantly reduced the occurrence of heart attack, the need for further procedures to open the artery, and stent thrombosis. Approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 clopidogrel patients.

FDA Approves Fycompa for Primary Generalized Tonic-Clonic Seizures

Fycompa is also approved to treat partial-onset seizures with or without secondarily generalized seizures Read More...

Fycompa (perampanel) is an anticonvulsant used with other medicines to treat seizures. Eisai Inc. has received approval from the FDA for Fycompa as adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. In clinical trials, Fycompa had statistically significant results compared to placebo for reduction in PGTC seizure frequency (Fycompa: -76.5%, placebo: -38.4%), and 30.9% of patients treated with Fycompa were free of PGTC seizures (12.3% for placebo) during the 13 week maintenance period. The most common side effects for Fycompa were dizziness, fatigue, headache, somnolence and irritability.

Investigational Agent Shown to Reverse Bleeding With Pradaxa

Idarucizumab is a humanized antibody fragment, or Fab

A study published in the New England Journal of Medicine reports that an investigational agent, idarucizumab, has been shown to rapidly reverse the bleeding that can occur with the blood thinner Pradaxa (dabigatran). Pradaxa is widely used to prevent blood clots and to reduce the risk of stroke in people with a heart rhythm disorder. However, there is no agent to reverse serious bleeding that may occur in some patients receiving Pradaxa, similar to the way that vitamin K reverses bleeding with warfarin. Researchers note that idarucizumab completely reversed the bleeding effect of dabigatran within minutes in all cases.

Xeljanz Shown to Ease Vitiligo: Study

Experts state since JAK inhibitors suppress the immune system, they may be effective in other autoimmune conditions Read More...

Vitiligo, a disfiguring loss of pigmentation in skin, was most notably suffered by pop star Michael Jackson. A small study published in JAMA Dermatology notes that a drug approved to treat rheumatoid arthritis, the JAK inhibitor tofacitinib (Xeljanz), may have an effect in treating vitiligo. The current treatments are limited to steroid creams and light therapy which are not reliably effective. Researchers used Xeljanz in one woman for five months, and the white spots on her face, hands and body were almost entirely gone. According to researchers, the woman did not have any negative side effects from the treatment, either.