Monday, July 6, 2009

Quit-Smoking Drugs Led to Suicide Attempts

Two drugs used primarily by smokers who would like to quit the habit will be required by the US Food and Drug Administration to carry boxed warnings about health risks – specifically the onset of symptoms that are neuropsychiatric in nature – that have been associated with the drugs.

quit smokingThe FDA has received reports regarding the effects of the drugs varenicline (Chantix) and buproprion (Zyban, Wellbutrin and generics). The agency reportedly started receiving reports two years ago, which included the onset of symptoms such a depression, suicidal thoughts and tendencies, agitation, hostility and other such changes in behavior. Among varenicline users, almost a hundred ended up committing suicide, while more than 180 have attempted suicide. There weren’t as many among buproprion users, with 14 suicides and 17 attempted suicides throughout the drugs’ respective marketing histories.

The agency further recommended that clinicians should monitor patients who have been prescribed the drugs to help them quit smoking. There were cases that the symptoms were resolved with the mere cessation of treatment, although this does not happen all the time. Monitoring should not only occur while a patient is in the midst of treatment but even after stopping medication, until such times that the symptoms have been fully resolved. While such neuropsychiatric symptoms are also characteristic of nicotine withdrawal, these also occurred in patients who are still smoking while taking the drugs.

Aside from placing warning labels on their products, the manufacturers of varenicline and buproprion will also be required to conduct a clinical trial which will look into the appearance of neuropsychiatric symptoms in patients who are taking the drugs. The trial should include patients who already have psychiatric disorders as a pre-existing condition before taking the drugs.

The drugs’ labels will also be updated to include, aside from the warning on neuropsychiatric risks, information about allergic and skin reactions as well as the risk of accidental injury when driving or operating machinery while taking the drugs.

Read more: http://hometestingblog.testcountry.com/?p=2902#ixzz0KW1hjySD&C

0 comments: