Smoking cessation drug Varenicline may cause Potential alcohol interaction & rare risk of seizures

Adr Bulletein by Shinu.C

Smoking cessation drug Varenicline may cause Potential alcohol interaction & rare risk of seizures

Varenicline is a prescription medicine that is used to help adults quit smoking.Clinical trials show that  the drug increases the likelihood of abstinence from smoking for as long as 1 year compared to treatment with placebo, an inactive treatment.

FDA is warning that the prescription smoking cessation medicine varenicline can change the way people react to alcohol. In addition, rare accounts of seizures in patients treated with this drug have been reported. FDA reviewed the case series& database describing patients who drank alcohol during treatment with  and experienced adverse reactions. Some patients experienced decreased tolerance to alcohol, including increased drunkenness, unusual or aggressive behavior, or they had no memory of things that happened. 48 cases of adverse events involving decreased tolerance to alcohol  or aggressive behavior  in patients taking varenicline and who also consumed alcohol were reported. Amnesia was also reported following alcohol ingestion in patients taking Varenicline.

FDA also reviewed FAERS and the medical literature and identified 64 cases of seizures with drug and identified cases in which the patients who had seizures while taking varenicline either had no history of seizures or had a seizure disorder that had been well-controlled. In most of these cases, the seizures occurred within the first month of starting the drug.

Several studies that investigated the risk of neuropsychiatric side effects on mood, behavior, or thinking occurring with Varenicline. These included observational studies, as well as analyses that conducted of randomized controlled clinical trial data.These studies did not show an increased risk of neuropsychiatric side effects.

Additional Information to patients:

varenicline may change the way people react to alcohol.

·Decrease the amount of alcoholic beverages you drink during treatment  until you know how it affects your ability to tolerate alcohol.

·Seizures have been reported in patients treated with varenicline

·Before you take drug, tell your health care professional if you drink alcohol, have a history of seizures, or have ever had depression or other mental health problems.

·If you have a seizure during treatment , stop taking the medicine and seek medical attention immediately.

·If you develop nervousness or agitation, hostility, aggressive behavior, depression, thoughts of suicide, or have other changes in your behavior or thinking that are not typical for you, stop taking drug and contact your health care professional right away.

·Talk to your health care professional if you have questions or concerns about the drug or would like information about quitting smoking.

·Report side effects from Varenicline

Additional information to health care professionals:

Interactions between alcohol and varenicline have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.

·Advise patients to reduce the amount of alcohol they consume while taking drug until they know whether the drug affects their tolerance for alcohol.

·Seizures have been reported in patients treated with this drug.

·Weigh the potential risk of seizures against the potential benefits before prescribing in patients with a history of seizures or other factors that can lower the seizure threshold.

·Advise patients to discontinue drug and seek medical attention immediately if they experience a seizure while on treatment.

·Advise patients to immediately stop taking drug if they develop agitation, hostility, aggressive behavior, depressed mood, or changes in behavior or thinking that are not typical for them, or if they develop suicidal ideation or behavior.

·Report adverse events involving Varenicline.