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Weekly Drug News Round Up - December 3, 2014

Amgen’s Blincyto Approved to Treat a Rare Form of Leukemia

Some common side effects were fever, headache, and swelling of tissues Read More...

The U.S. Food and Drug Administration has approved Blincyto (blinatumomab), an immunotherapy drug (a bispecific T cell engager, or BiTE antibody) used to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), a rare form of bone marrow cancer. Blincyto works by using the immune system to fight off cancer, and is the first drug approved that activates T-cells, a type of white blood cell, to kill leukemia. Blincyto also comes with a boxed warning about problems with low blood pressure and difficult breathing at treatment initiation. Blincyto was granted breakthrough therapy designation, priority review and orphan product status by the FDA.

Use Quickly! New Allergy Guidelines for Epinephrine

Allergists and emergency physicians discuss ways to get the word out Read More...

A new report suggests not all medical personnel are aware of the importance of quick action using injectable epinephrine (EpiPen, Auvi-Q) in a severe allergic reaction, also called anaphylaxis. Common culprits leading to anaphylaxis include certain foods like peanuts or peanut butter, latex, or a bee sting. Throat swelling, trouble breathing, heart attack and even death may occur. According to the experts, there is no reason not to use epinephrine on someone who is believed to be having a severe allergic reaction. The new guidelines were published online this week in the Annals of Allergy, Asthma and Immunology.

FDA Approves Priftin Extra Use Under Priority Review

Priftin has been approved since 1998 for the treatment of active pulmonary TB caused by Mycobacterium tuberculosis Read More...

A person with latent tuberculosis infection (LTBI) is infected with the bacteria that causes TB, but does not have active TB and is not yet contagious. The U.S. Food and Drug Administration has approved a new use for Priftin (rifapentine) in combination with isoniazid (INH) to treat LTBI in patients two years of age and older at high risk of progression to active TB. More than 11 million people living in the U.S. have LTBI, and more than 1 million people will develop TB disease if not treated. CDC recommends the 12-dose Priftin-INH combination (with Directly Observed Therapy) as an alternative to nine months of daily INH.

Final FDA Rule on Pregnancy and Lactation Labels Published

Three new subsections are titled: Pregnancy; Lactation; and Females and Males of Reproductive Potential Read More...

The U.S. Food and Drug Administration (FDA) has published the Final Rule describing how some written information for prescription drugs and biological products (the “label”) will change. Previously, information presented in product labels that classified the risks of prescription drugs in pregnancy was oversimplified by a lettering system - A, B, C, D and X. The new content will contain three subsections that describe risks within a real-world context. The detailed subsections will include pregnancy and breastfeeding, a discussion of the data supporting the summary, and provider information for counseling and prescribing decisions.

Rheumatoid Arthritis: New Options for Treatment

Becoming involved your RA treatment plan is important for its success Read More...

Rheumatoid arthritis (RA) is a chronic inflammatory disease that leads to pain, swelling and destruction of joint tissues. RA usually occurs in people between the ages of 20 and 50 years old, but it can affect children and seniors, too. At least three-quarters of people afflicted with RA are women. The treatment of RA has significantly improved in the last 50 years -- treatments have allowed patients to control pain, remain active, and limit progressive joint destruction. Review the latest treatment options, like adalimumab (Humira), tocilizumab (Actemra), and oral tofacitinib (Xeljanz), plus tips on exercise and non-drug ways to control symptoms.

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