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Weekly Drug News Round-Up: February 24, 2016

Briviact Wins FDA Approval As Adjunct for Partial Onset Seizures

Roughly 2.9 million people in the United States have active epilepsy Read More...

Epilepsy is a brain disorder that causes people to have recurring seizures, consisting of uncontrollable muscle movements, abnormal sensations or thinking. The U.S. Food and Drug Administration (FDA) has approved Briviact (brivaracetam) as an add-on treatment for partial onset seizures in patients age 16 years and older with epilepsy. Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam. In clinical trials involving 1,550 participants, Briviact was shown effective as an adjunct to reduce seizure activity, with common side effects including drowsiness, dizziness, fatigue, nausea and vomiting.

FDA Expands Breast Cancer Indication for Pfizer’s Ibrance

Ibrance was first approved in 2015, in combination with letrozole, in postmenopausal women Read More...

Ibrance (palbociclib) is a first-in-class cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor approved by the FDA for advanced breast cancer. Ibrance is now approved in HR+, HER2- metastatic disease in combination with fulvestrant in women with disease progression following endocrine therapy, regardless of menopausal status. The Phase 3 PALOMA-3 trial enrolled 521 women to receive Ibrance plus fulvestrant or placebo plus fulvestrant. In the Ibrance plus fulvestrant arm, progression-free survival (PFS) was statistically significant at a median of 9.5 months compared to 4.6 months in the fulvestrant/placebo group.

ACOG Guidelines: Vaginal Estrogen in Breast Cancer Survivors

The new guidelines will appear the March issue of Obstetrics & Gynecology Read More...

Women with an estrogen-dependent breast cancer often suffer vaginal symptoms, like dryness or painful sex, linked to treatment, especially around menopause. Clinically there have been concerns about a possible link between topical (cream or lotion) estrogen therapy and recurrence of estrogen-linked breast cancers. However, current research has not confirmed such a connection. In a new set of guidelines, the American College of Obstetricians and Gynecology (ACOG) still recommend non-hormonal treatment, such as vaginal moisturizers, as first-line for vaginal symptoms. However, ACOG now states topical estrogen therapy can also be considered for estrogen-dependent breast cancer survivors who do not respond to non-hormonal therapies.

CDC: HPV Infection Rates Declining in Teen Girls

The CDC currently recommends HPV vaccination at age 11 or 12 for both girls and boys Read More…

The human papillomavirus (HPV) vaccine -- Cervarix, Gardasil and Gardasil 9 -- are controversial vaccines approved for use in adolescent girls and boys to cut rates of HPV infection that can lead to cervical and other cancers. Researchers from the CDC now say that due to HPV vaccine use, infections from this virus have been cut by 64 percent among teen girls. Among girls aged 14 to 19, the prevalence of the types of HPV targeted by the vaccine dropped from 11.5 percent in 2003-2006 to 4.3 percent in 2009-2012. However rates of vaccination are still too low: only 42 percent of girls and 22 percent of boys have received the 3-dose vaccine.

Benzodiazepines: Also a Risk for Fatal Overdose

Benzodiazepines are often prescribed for anxiety, mood disorders and insomnia Read More...

While addiction and overdoses have focused on opioid narcotics in recent news, another class of medication is making headlines with fatal overdoses. Researchers have found that benzodiazepine sedatives, such as alprazolam (Xanax) and diazepam (Valium), accounted for 31 percent of 23,000 deaths in the US from prescription drug overdoses in 2013. Even more concerning, the experts stated that roughly 75 percent of overdoses that involve benzodiazepines also involve narcotics. Depressed breathing can be a fatal complication when benzodiazepines are combined with alcohol or other sedative-type drugs. Tighter regulations, such as limiting prescription quantities and selecting other non-habit forming drugs, plus added patient education, are needed.