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Monthly News Round Up - September 2013

New FDA Boxed Warning: Increased Risk of Death with Tygacil

Tygacil (tigecycline) is an antibiotic approved to treat complicated skin and intra-abdominal infections, and community-acquired bacterial pneumonia. The U.S. Food and Drug Administration (FDA) has issued a boxed warning for intravenous Tygacil detailing an increased risk of death. FDA analysis showed a higher risk of death among patients receiving Tygacil for FDA-approved uses compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions. FDA issued a previous Drug Safety Communication about this safety concern in September 2010.

Janssen Biotech's Stelara FDA-Approved to Treat Active Psoriatic Arthritis

The U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients with psoriatic arthritis. Psoriatic arthritis is form of arthritis characterized by both joint inflammation and psoriasis. Stelara, also approved for use in plaque psoriasis, blocks interleukin cytokines to reduce inflammation. In Phase 3 clinical trials, 42 to 50 percent of patients receiving Stelara achieved at least a 20 percent improvement at week 24 in the ACR 20, the primary endpoint. The safety profile of Stelara in psoriatic arthritis trials was similar to that seen in plaque psoriasis trials.

Celgene’s Abraxane Approved for Late-Stage Pancreatic Cancer

The U.S. Food and Drug Administration (FDA) has approved an added indication for Abraxane (paclitaxel protein-bound) to be used in the treatment of late-stage (metastatic) pancreatic cancer. Abraxane, a taxane chemotherapeutic drug, is also approved for the treatment of advanced breast and lung cancer. Abraxane is used with gemcitabine (Gemzar), another chemotherapy drug, in patients with metastatic pancreatic cancer. In clinical trials, patients who were treated with Abraxane plus gemcitabine experienced a delay in tumor growth for an average of 1.8 months and lived, on average, 1.8 months longer than those treated with gemcitabine alone.

Botox Cosmetic Approved to Improve the Appearance of Crow’s Feet Lines

Botox Cosmetic (onabotulinumtoxinA), the popular injectable treatment used to smooth wrinkles between the eyebrows (frown lines), has been approved by the U.S. Food and Drug Administration (FDA) to treat crow’s feet in adults, medically known as lateral canthal lines. In clinical trials, 833 subjects with moderate to severe lateral canthal lines had greater improvement in their appearance of “crow’s feet” around the eyes compared to placebo. The most common side effect was eyelid edema, a condition in which the eyelids are swollen and contain excessive fluid. Treatment for both frown lines and crow’s feet can be given at the same time.

Teva To Market First Generic Capecitabine for Colorectal and Breast Cancers

In 2013, over 375,000 patients will be diagnosed with either breast cancer or colorectal cancer, and over 90,000 of these patients will die. Cancer medications are notoriously expensive, but this week the U.S. Food and Drug Administration (FDA) has approved the first generic version of Xeloda (capecitabine), which should lower out-of-pocket costs for patients. Capecitabine, given orally as a pill, is used in the treatment of colorectal cancer and breast cancer that has spread in the body (metastatic). Patients receiving capecitabine and coumarin-derivative anticoagulants like warfarin should have their anticoagulant response monitored frequently.

Posted: September 2013