FDA Flags Reports of Suicidal Thoughts, Aggressive Behavior With Varenicline

Susan Jeffrey

November 20, 2007 — The US Food and Drug Administration (FDA) has informed healthcare professionals about reports of suicidal thoughts as well as some aggressive and erratic behavior in patients who have taken varenicline (Chantix, Pfizer), a smoking-cessation product.

The FDA is currently reviewing these cases along with other recent reports, according to an alert from MedWatch, the FDA's safety information and adverse reporting system. Their preliminary assessment shows that many of the cases reflect new-onset depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating treatment with varenicline, the alert said.

"The role of Chantix in these cases is not clear, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has been associated with the exacerbation of underlying psychiatric illness," the FDA MedWatch alert said. "However, not all patients described in the cases had preexisting psychiatric illness, and not all had discontinued smoking."

In one highly publicized case, the FDA notes, erratic behavior led to the death of a patient using varenicline to quit smoking. "Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar," the agency says. "We are currently evaluating the material Pfizer submitted in response to our request."

There are additional reports of patients experiencing drowsiness that affected their ability to drive or operate machinery, the FDA alert notes.

The FDA recommends that healthcare professionals monitor patients taking varenicline for behavior and mood changes, and that patients taking the drug should report any behavior or mood changes to their physician. Patients should also be told to use caution when driving or operating machinery until they know how quitting smoking using this agent will affect them.

The FDA is working to complete an analysis of all the materials submitted by Pfizer, and when the analysis is completed, the FDA will communicate its conclusions and recommendations to the public, the agency notes.

The complete MedWatch safety summary, including a link to the FDA Early Communication Sheet about the ongoing safety review on this issue, can be found at http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix.

Adverse events related to varenicline therapy should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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http://www.medscape.com/viewarticle/566341?src=mp

        

Gracias Dr. José Manuel Ferrer Guerra!!

Lack of Sleep Linked to Weight Gain For New Moms, Study Says

Monday, November 19, 2007

As if being a new mom wasn't hard enough — there's new evidence that mothers who don't get a lot of sleep are more likely to pack on baby weight, according to a new study by Kaiser Permanete and Harvard Medical School/Harvard Pilgrim Health Care.

Researchers found that moms who got less than five hours of sleep a day when their babies were 6 months old were three times more likely to be carrying 11 extra pounds at the child's first birthday than those who get seven hours. The bottom line –- those extra two hours of sleep could make all the difference.

"We've known for some time that sleep deprivation is associated with weight gain and obesity in the general population, but this study shows that getting enough sleep — even just two hours more — may be as important as a healthy diet and exercise for new mothers to return to their pre-pregnancy weight," said lead study author Dr. Erica P. Gunderson, an investigator at the Kaiser Permanente Division of Research, in a news release.

The study also found that mothers who slept fewer hours at one year postpartum than they did at six months postpartum had twice the risk of substantial weight retention. Other studies have shown that persistent sleep deprivation causes hormonal changes that may stimulate appetite.

"With the results of this study, new mothers must be wondering, 'How can I get more sleep for both me and my baby?' Our team is working on new studies to answer this important question," said Dr. Matthew W. Gillman, Department of Ambulatory Care and Prevention at Harvard Medical School/Harvard Pilgrim Health Care, in a news release.

More than 900 women with a median age of 33 participated in the study. Forty-seven percent of the women were first-time mothers, 37 percent had two children and 16 percent had three or more children.

The study was published in the November issue of the American Journal of Epidemiology.

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