Quick Hits: Changes to Chantix Boxed Warning & More

The FDA should remove a serious warning on the risk of suicidal thoughts from Pfizer’s quit smoking drug Chantix, according to a majority of independent advisors to the agency. Since 2009, Chantix (varenicline) has had a “black box” warning — the most stringent the FDA can require — warning of serious neuropsychiatric events, including agitation, hostility, depressed mood and suicidal ideation associated with the drug. However, results of a new study funded by Pfizer, Chantix’s manufacturer, showed that patients with or without a history of mental illness taking Chantix did not have more psychiatric episodes than those on placebo.  A total of 10 advisory committee members voted to remove the warning completely, 4 voted to change the language of the warning based on the new data and 5 voted to keep the warning as is. The FDA is not obligated to follow the recommendations of its advisors, but usually does. Posted September 14, 2016. Via MedPage Today.

About a quarter of all seniors who take blood pressure medications aren’t taking them correctly, leaving them at higher risk for heart disease or stroke. The CDC (Centers for Disease Control and Prevention) conducted an analysis of 18.5 million Medicaid enrollees taking the drugs. They found that 26% of them skipped doses or stopped taking the medication. The survey also found that Native American, African-Americans and Hispanics were the most likely to not stick to their medication regiment. While 70% of Americans aged 65 and older have hypertension, just over half of them have their blood pressure under control. Posted September 13, 2016. Via CDC.

Prescribing long-acting opioids for moderate-to-severe pain is associated with a higher death rate than if other medications are used. Mortality in patients on long-acting opioids for noncancer pain was 64% higher than in patients prescribed an analgesic anticonvulsant or low-dose antidepressant instead, according to research published in JAMA. The retrospective study also found that the opioid group has a 65% greater chance of cardiovascular death and a 4 times greater increase in death in the first 30 days of therapy compared with those on other medications. The findings tend to reinforce CDC recommendations that opioids should be reserved only for pain related to cancer, end-of-life, or palliative care. Posted September 15, 2016. Via JAMA.

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