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Weekly Drug News Round Up - August 5, 2015

FDA Approves Aprecia’s Spritam: First Drug Made With 3D Technology

Easier swallowing may prevent episodes of breakthrough seizures Read More...

The U.S. Food and Drug Administration (FDA) has approved oral Spritam (levetiracetam) for add-on therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. ZipDose Technology enables the delivery of a single high dose, up to 1,000 mg with just a sip of liquid. In addition, each dose is individually packaged, making it easy to carry this treatment on the go. Levetiracetam is available in generic and by the other brand names and dose forms known as Keppra, Keppra XR and Elepsia XR. Spritam is expected to be available in the first quarter of 2016.

FDA Approves Bayer’s Finacea Foam for Rosacea

You may be more likely to have rosacea if you are age 30 to 50, fair-skinned, and a woman Read More...

Rosacea is a skin disease causing red lesions (papules and pustules) on the nose, cheeks, chin and forehead. The FDA has approved Finacea Foam (azelaic acid), 15% for the topical treatment of of mild to moderate rosacea. Finacea is also available as a gel. The approval is based on results from two clinical trials examining the efficacy and safety of Finacea Foam. The most frequently observed side effects with Finacea Foam included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%). Azelex cream is another brand name of azelaic acid, but approved to treat acne.

Brintellix and Brilinta: FDA Warns of Brand Name Confusion

No reports indicate that a patient ingested the wrong medication, but errors continue Read More...

The U.S. Food and Drug Administration (FDA) is warning healthcare providers and patients that reports of confusion between the SSRI antidepressant Brintellix (vortioxetine) and anti-blood clotting medication Brilinta (ticagrelor) have resulted in the wrong medication being prescribed or dispensed due to the similarity of their brand (proprietary) names. Health care professionals should include the generic and brand name and the indication for use when prescribing these medications. Pharmacists should also consider placing the medication bottles in separate pharmacy areas. Patients should check their prescriptions when received.

Medwatch: FDA Warns About Rare Brain Infection With Gilenya

Patients should not stop taking Gilenya without first discussing it with their health care professionals Read More...

The first cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS) who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus . FDA is warning that a case of definite PML and a case of probable PML have been seen. Patients taking Gilenya should contact their healthcare provider right away if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.

Birth Control Pills May Cut Women's Odds for Uterine Cancer

The protective effect against uterine cancer can last for decades after stopping the birth control pill Read More...

A new British research study shows that taking birth control pills, even for just a few years, offers significant long-term protection against uterine cancer, also known as endometrial cancer. In fact, about 200,000 cases of uterine cancer were prevented between 2005 and 2014 alone. Researchers analyzed data from 36 studies involving a total of more than 27,000 women with uterine cancer. They found that in high-income nations, 10 years of birth control pill use lowered the risk of developing the disease before age 75 from 2.3 to 1.3 cases per 100 users. The pill also can protect against ovarian cancer.