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And other news from the US Food and Drug Administration
March 2016, Vol 4, No 3 - Inside Drug Update

New Drugs

The following are recent approvals announced by the US Food and Drug Administration (FDA):

  • Briviact (Brivaracetam) has been approved by the FDA as a supplemental treatment to other medications for patients aged ≥16 years with epilepsy who have partial onset seizures. Drowsiness, dizziness, fatigue, and nausea and vomiting were the most commonly reported adverse effects associated with the drug.
  • Zepatier (elbasvir and grazoprevir) has been approved, with or without ribavirin, for adult patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections. Fatigue, headache, and nausea were the most commonly reported adverse effects of Zepatier monotherapy, and anemia and headache were the most common adverse effects of Zepatier with ribavirin. The FDA recommends that healthcare professionals determine the dosage regimen and duration by screening genotype 1a–infected patients for certain viral genetic variations before initiating Zepatier.
  • Cosentyx (secukinumab) has received FDA approval for use in adult patients with moderate-to-severe plaque psoriasis. Administered as a subcutaneous injection, Cosentyx is intended for candidates of systemic therapy, phototherapy, or both. Because serious allergic reactions have been reported with use of the drug, healthcare providers should use caution when considering Cosentyx for patients with a chronic infection or history of recurrent infection, and in patients with active Crohn’s disease. Diarrhea and upper respiratory infections are among the most common adverse effects reported with Cosentyx use.

Announcements

  • The FDA recently announced that Robert Califf, MD, MACC, FDA Deputy Commissioner for Medical Products and Tobacco, and other agency officials have responded to the opioid abuse endemic by requesting a broad reassessment of the FDA’s opioid medication policies. The review will include re-examination of the risk–benefit profile of opioids, meeting with the Pediatric Advisory Committee to discuss pediatric opioid labeling, and encouraging the creation of abuse-deterring opioid product formulations.
  • According to a recent announcement by the FDA, the organization has issued a new guidance recommending that blood establishments postpone accepting blood donations from patients who have visited areas where the Zika virus is active, were possibly exposed to the virus, or have had a confirmed Zika virus infection. Although no news of the Zika virus entering the US blood supply has been reported, the risk for blood transmission is considered a possibility by the FDA.



  1. US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/News room/PressAnnouncements. Updated February 22, 2016. Accessed February 22, 2016.
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Last modified: March 25, 2016
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