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Weekly Drug News Round Up - March 25, 2015

FDA Approves Anthrasil for Inhalation Anthrax

Most commonly observed side effects were headache, back pain, nausea and infusion site pain and swelling Read More...

The U.S. Food and Drug Administration (FDA) has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs. Anthrax bacteria Bacillus anthracis can be inhaled after exposure to infected animals or after intentional release of anthrax spores. When inhaled, the anthrax bacteria produce toxins that can cause massive and irreversible tissue injury and death. Anthrasil is manufactured from the plasma of individuals vaccinated against anthrax. The plasma contains antibodies that neutralize toxins produced by the anthrax bacteria. Anthrasil will be stored in the U.S. Strategic National Stockpile in case of an anthrax emergency.

FDA Medwatch: Possible Fatal Heart Reaction with Harvoni or Sovaldi

Harvoni and Sovaldi are novel drugs recently approved for the treatment of Hepatitis C; prescription labels will be updated Read More...

The U.S. Food and Drug Administration (FDA) released a Medwatch alert this week warning that serious slowing of the heart rate (bradycardia) can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. FDA is recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone. If there are no alternatives, heart rate monitoring should be instituted if the drugs are combined.

Drug Safety Update: Zyprexa Relprevv Linked with Two Deaths

The two patients died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv Read More...

Zyprexa Relprevv (olanzapine pamoate) is an extended release, injectable atypical antipsychotic used to treat adults with agitation due to schizophrenia or bipolar disorder (manic depression). Zyprexa Relprevv is not for daily use. FDA is unable to exclude the possibility that two deaths associated with the drug were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. A study suggested that the drug level increase could have occurred after death. FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop Zyprexa Relprevv without first talking to their doctor.

Eylea Approved for Diabetic Retinopathy in Diabetic Macular Edema Patients

The FDA granted breakthrough therapy designation to Eylea for this new indication Read More...

Regeneron’s Eylea (aflibercept) is a drug currently approved to treat macular degeneration, macular edema, and diabetic macular edema. Today, the FDA expanded the approved use of Eylea injection to treat diabetic retinopathy (DR) in patients with diabetic macular edema. In clinical studies, 679 participants randomly received Eylea or macular laser photocoagulation, a laser-based treatment used to burn small areas of the retina. At week 100, participants being treated with Eylea showed significant improvement in the severity of their DR, compared to patients who did not receive Eylea. Common side effects included bleeding of the conjunctiva, eye pain, and increased eye pressure.

Small Study Suggests Vitamin D Might Slow Prostate Cancer Growth

Experts state that decreased inflammation due to vitamin D may thwart the cancer growth Read More...

Researchers suggest that vitamin D may slow or prevent low-grade prostate cancer growth. In a small study, the researchers randomly assigned 37 men having their prostate removed to either 4,000 international units (IU) of vitamin D or an inactive placebo daily for 60 days before their operation. In 60 percent of those who took the vitamin D, the cancer either shrank or went away, but the tumors remained the same or worsened in the placebo group. Other experts state larger studies are needed before making conclusions about vitamin D value in prostate cancer.