Mel (VNI) (9 messages)
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08-11-03, 21:18 (GMT)
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4. "RE: Bupropion - Zyban Comment arrêter le traitement ??????" |
ZybanSafetyUpdate100102revised version.doc
tZyban (bupropion hydrochloride) - safety update
Remember Zyban is contraindicated in patients with previous or current seizure disorder.
Zyban was licensed in June 2000 as an aid to smoking cessation in combination with motivational
support in nicotine-dependent patients. Information on the safety profile of Zyban can be found in the
authorised Summary of Product Characteristics (SPC), and the Patient Information Leaflet (PIL). Up to
30 November 2001 it is estimated that approximately 500,000 patients have received Zyban in the UK.
Up to 10 January 2002, a total of 6,975 reports of suspected adverse reactions have been received via the
Yellow Card Scheme in the UK. The reactions most commonly reported through the Yellow Card
Scheme are shown in the table below - all of these are recognised reactions and listed in the SPC and
PIL. It is important to note that the suspected reactions are not necessarily caused by the drug and may
relate to other factors such as nicotine withdrawal, other illnesses or other medicines taken concurrently.
Reported reaction Number of reports Reported reaction Number of reports
Insomnia 919 Dyspnoea 217
Urticaria 915 Palpitations 227
Rashes 802 Dry mouth 222
Headache 680 Vomiting 214
Dizziness 667 Agitation 191
Nausea 581 Increased Sweating 178
Depression 448 Chest Tightness 171
Angioedema 406 Seizures 168
Tremor 329 Arthralgia 164
Pruritus 341 Constipation 157
Chest pain 313 Abdominal Pain 156
Anxiety 292 Malaise 156
(Please note that many reports contain more than one of the above-mentioned reactions, and therefore the sum of the number
of reports in this table exceeds the total number of reports received for Zyban.)
Zyban is associated with a dose-related risk of seizure with an estimated incidence of approximately
0.1% (1/1,000). There have been 168 reports in the UK of seizures suspected as being associated with
the use of Zyban. In approximately one-half of the reports, patients had either a past history of seizure(s)
and/or risk factors for their occurrence.
To reduce the risk of seizures, prescribers are reminded that Zyban is contraindicated in patients with a
current seizure disorder or any history of seizures, with current or previous diagnosis of bulimia or
anorexia nervosa, with a known central nervous system (CNS) tumour, and those experiencing abrupt
withdrawal from alcohol or benzodiazepines.
Furthermore, Zyban should not be prescribed in patients with other risk factors for seizures unless there
is compelling clinical justification for which the potential benefit outweighs the increased risk of seizure.
Such risk factors include concomitant use of any drug known to lower the seizure threshold (including
antipsychotics, antidepressants, antimalarials, theophylline, systemic steroids, tramadol, quinolones and
sedating antihistamines), alcohol abuse, a history of head trauma, diabetes treated with hypoglycaemics
or insulin and use of stimulants or anorectic products. In such patients a lower dose of 150mg daily
throughout the entire treatment period should be considered.
To date there have been 57 reports of suspected adverse reactions to Zyban which had a fatal outcome.
In the majority of these cases the individual’s underlying condition may provide an alternative
explanation. Cardiovascular disorders including myocardial infarction and cerebrovascular disorders
including stroke were the reported cause of death in 80% of these reports. In 14 of these reports the
individual was not taking Zyban at the time of death.
As with all new drugs, the safety of Zyban remains under close review. Doctors and pharmacists are
asked to continue to report all suspected adverse reactions to the MCA/CSM.
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