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Weekly Drug News Round Up - May 28, 2014

Durata’s Once-a-Week Antibiotic Dalvance Approved for Skin Infections

Dalvance dosage must be adjusted in patients with renal impairment Read More...

The U.S. Food and Drug Administration has approved injectable Dalvance (dalbavancin), a new lipoglycopeptide antibiotic used to treat adults with acute bacterial skin and skin structure infections caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes. Dalvance is the first drug FDA-designated as a Qualified Infectious Disease Product (QIDP), intended to encourage development of novel antibacterial agents. In clinical trials, subjects received Dalvance or vancomycin, another antibacterial drug; Dalvance was as effective as vancomycin for the treatment of the skin infections. Common side effects with Dalvance include nausea, headache and diarrhea.

Adjuvant Tamoxifen Therapy Now Recommended for Ten Years

Hormone receptor-positive breast cancer is the most common type of breast cancer worldwide Read More...

Updated guidelines from the American Society of Clinical Oncology (ASCO) recommend that tamoxifen be given for as long as 10 years following treatment of certain types of breast cancer. Previously, the standard was five years of tamoxifen treatment, but evidence now points to at least 10 years for women with hormone receptor-positive breast cancer between stage 1 and stage 3. According to the guideline published in the Journal of Clinical Oncology, women who took tamoxifen for 10 years survived longer and were less likely to have their breast cancer return. No new tamoxifen side effects were identified over the 10-year period.

FDA Consumer Update: Lupus Therapies Continue to Evolve

African-American women are at a high risk of developing Lupus, which typically begins between the ages of 15 and 44 Read More...

The U.S. Food and Drug Administration (FDA) is highlighting National Lupus Month in the Consumer Updates this month. Lupus is an autoimmune disease that can damage multiple areas of the body, including the joints, kidneys, heart, lung, blood vessels and brain. The most common form, called systemic lupus erythematosus (SLE), can lead to mouth sores, rash, fatigue, joint pain and swelling, as well as affect the kidneys. Aspirin, corticosteroids, and hydroxychloroquine (Plaquenil) have been used in treatment; most recently FDA approved Benlysta (belimumab) - the first targeted therapy for lupus - in 2011.

FDA Targets Worldwide Illegal Prescription Drug Online Market

Some countries have less stringent drug manufacturing standards that put U.S. consumers at risk Read More...

The U.S. Food and Drug Administration (FDA) seized over 19,600 packages of unapproved and potentially dangerous prescription drugs this week in a global effort to halt the sale of these drugs to Americans. Packages were marked as originating from countries such as Australia, Canada, and New Zealand, but the packages actually contained unapproved or fake drugs from countries such as China, India, and Mexico. The drugs, ordered online by U.S. consumers, included insulin, pain medications such as tramadol, and drugs for erectile dysfunction like tadalafil and sildenafil. Hormonal drugs including estrogen and HCG were also confiscated. The FDA has additional information about fraudulent online pharmacies.

Xanax Abuse is Dangerously On the Rise

Prescription sedatives and painkillers should be locked up while in use and properly disposed of when no longer needed Read More...

The number of emergency department visits related to abuse of alprazolam (brand names Xanax, Xanax XR, and Niravam) climbed from more than 57,000 in 2005 to nearly 124,000 in 2011, according to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA). The rise is especially alarming in light of the rise seen in abuse of opioids, such as oxycodone (Oxycontin) and hydrocodone (Vicodin). According to experts, these abuse levels parallel an increasing rise in accidental overdose deaths. When alprazolam is combined with opioids and/or alcohol, the abuser may fall asleep and stop breathing, never to awaken.

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