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Weekly Drug News Round Up - August 15, 2012

FDA: Codeine Use in Children with Genetic Enzyme Variation May Lead to Death

Health care providers should consider alternate analgesics in these situations or only prescribe codeine on an as-needed basis Read More...

The U.S. Food and Drug Administration (FDA) has issued a drug safety communication detailing life-threatening adverse reactions and death that have occurred in certain children receiving codeine for analgesia after a tonsillectomy and/or adenoidectomy for obstructive sleep apnea. Codeine is converted in the liver to morphine by an enzyme known as cytochrome P450 2D6 (CYP2D6). “Ultra-rapid metabolizers”, those with extra CYP2D6 enzyme activity may develop higher blood levels of morphine than those who do not have the genetic enzyme variation. High levels of morphine can lead to slowed breathing, which may be fatal.

Flu Vaccine Approved for 2012-2013 Season

Two new influenza viral strains are circulating but are included in this season's vaccine Read More...

Getting the influenza (flu) vaccine is still the best way to protect yourself from getting the flu. This year it is especially important to be vaccinated as the approved 2012-2013 flu vaccine contains two new strains based on global surveillance. Last year's vaccine did not have these new strains. The three strains included in the 2012-2013 vaccine are A/California/7/2009 (H1N1)-like virus, A/Victoria/361/2011 (H3N2)-like virus, and B/Wisconsin/1/2010-like virus. The H3N2 and B viral strains are different from last season’s vaccine, but the H1N1 strain is the same. Early fall is the optimal time to receive the flu vaccine.

Auvi-Q (epinephrine injection) Approved with Audio and Visual Cues

Print and audio instructions guide patient or caregiver through the auto-injector administration technique Read More...

The first line of defense in avoiding a life-threatening allergic reaction (anaphylaxis) is to avoid the allergen, which may include nuts, shellfish, dairy, eggs, insect bites, latex and medications, among others. However, if contact with the allergen does occur, it is important to be able to respond quickly. The U.S. Food and Drug Administration has approved Auvi-Q (epinephrine injection) as the first auto-injector that can talk users through each step of the injection process. Auvi-Q is available in two different dosages - Auvi-Q 0.15 milligram (mg) for patients who weigh 33 to 66 pounds and Auvi-Q 0.3 mg for patients over 66 pounds.

Marqibo Approved For Treatment of Rare Type of Leukemia

Marqibo approved as an orphan drug under FDA accelerated approval program to allow patients earlier access to promising drugs Read More...

The U.S. Food and Drug Administration (FDA) has approved Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL). ALL is a fast-growing cancer of white blood cells (lymphocytes). These cells are found in the bone marrow, blood and other parts of the body. Marqibo is approved for patients whose leukemia has returned or progressed following two or more regimens of standard anti-leukemia treatment. In a clinical trial in 65 patients, 10 patients responded to Marqibo with either a complete remission or a complete remission with incomplete blood count recovery lasting a median of 28 days.

Lucentis FDA-Approved for Diabetic Macular Edema

Until now, laser surgery has been the only approved treatment for diabetic macular edema Read More...

Diabetes is the second leading cause of new cases of blindness in patients 20 to 74 years of age. Diabetic macular edema (DME) occurs when fluid leaks into the macula, or the center of the eye’s retina. This fluid causes the macula to swell and thicken, leading to blurred and distorted vision. The U.S. Food and Drug Administration (FDA) has approved Lucentis (ranibuzumab injection) for treatment of DME. Side effects may include eye tissue bleeding, eye pain, "floaters" and increased pressure within the eye. Lucentis was previously approved for wet age-related macular degeneration.