Pharma Effects

Posts Tagged ‘Cardiac Patients’

Seizure is the most controversial side effect of Wellbutrin, and was responsible for its initial withdrawal from the market. The risk of seizure is highly dose-dependent: 0.1% at 100–300 mg of Wellbutrin, 0.4% at 300–450 mg, and 2% at 600 mg. For comparison, the incidence from the very first unprovoked seizure within the general population is 0.07–0.09%. The risk of seizure for other antidepressants is as follows: 0.1–0.6% for imipramine, based on dosage; 0–0.06% for amitriptyline, depending on dosage; 0.5% for clomipramine; 0.4% for maprotiline; and 0.2% for fluoxetine and fluvoxamine. Experiments on mice indicate that increased susceptibility to seizure is a basic side effect of chronically utilizing antidepressants that inhibit norepinephrine transporter, for example imipramine, desipramine and reboxetine. Clinical depression itself was reported to increase the occurrence of seizures two-to-sevenfold in comparison with the basic population; in this light, the above statistics could indicate that low to moderate doses of antidepressants, including Wellbutrin, may really have an anti-convulsive action.

The prescribing info notes that hypertension, sometimes severe, was observed in some sufferers, both with and without having pre-existing hypertension. The frequency of this adverse impact was under 1% and not significantly higher than that discovered with placebo. In a group of cardiac patients with depression, high doses of Wellbutrin (400–500 mg/day) caused a rise in supine blood pressure but had no impact on pulse rate. No statistically significant changes in blood pressure or heart rate occurred in sufferers with or without heart conditions at a lower dose of 300 mg/day. In a analyze of Wellbutrin for ADHD, a rise of systolic blood pressure by 6 mm Hg and of heart rate by 7 beats per minute (both statistically significant) had been observed. A analyze of smokers hospitalized for heart disease found a 1.5-fold increase (close to being statistically substantial) in subsequent cardiovascular events within the Wellbutrin group, in comparison with the placebo group, but found no difference in blood pressure. Although the cardiovascular Wellbutrin side effects appear to be mild, it cannot be recommended for sufferers with heart disease, since the safety comparison with SSRIs (for example sertraline and fluoxetine, which might have a preventative impact after a myocardial infarction) is not in its favor.

In the UK, more than 7,600 reports of suspected undesirable reactions had been collected within the very first two years after bupropion’s approval by the MHRA as part of the Yellow Card Scheme, which monitored side effects. Approximately 540,000 individuals were treated with Wellbutrin for smoking cessation during that period. The MHRA received 60 reports of “suspected [emphasis MHRA's] adverse reactions to Zyban which had a fatal outcome”. The agency concluded that “in the majority of cases the individual’s underlying condition may offer an alternative explanation.” This is consistent with a large, 9,300-patient security analyze that showed that the mortality of smokers taking Wellbutrin isn’t greater than the natural mortality of smokers of exactly the same age.

Other isolated undesirable Wellbutrin side effects have been reported. Three cases of liver toxicity have been described, a very low incidence given the widespread use of the drug. A single case of clitoral priapism (clitorism) has been reported within the literature.

The common undesirable results associated with 12-hour sustained-release Wellbutrin (using the greatest difference from placebo) are dry mouth, nausea, insomnia, tremor, excessive sweating and tinnitus. Those that most often resulted in interruption of the treatment in the same trial were rash (2.4%) and nausea (0.8%).