Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA

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In trials that had more than two intervention groups, we preserved randomization but collapsed the multiple intervention arms (e. Publication bias was estimated via examination of asymmetry in a funnel indications for a. The selection of studies included in our review is summarized in Figure 1. Fourteen Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA placebo-controlled trials were included in the meta-analysis.

Characteristics of the trials are summarized in Table 1 and Appendix 2 (available at www. The 14 double-blind placebo-controlled trials enrolled a total of 8216 patients (4908 in the varenicline arms, 3308 in the placebo arms). The sample sizes ranged from 250 to 1210. The duration of treatment ranged from 7 weeks to 52 weeks, and the total duration of study, including treatment and follow-up, ranged from 24 to 52 weeks.

Three Intravdnous reported on lower doses of varenicline. The meta-analysis showed a significantly increased risk of serious adverse cardiovascular events associated with varenicline compared with placebo (Peto OR 1.

An odds ratio (OR) greater than 1. The sensitivity analysis in which we included data for active comparators (nicotine replacement therapy in the open-label trial29 and bupropion in two placebo-controlled trials19,20) showed results similar to those of the the primary analysis (Peto OR 1. There was no evidence of publication bias Immuhe the primary Allzital (Allzital Butalbital and Acetaminophen Tablets)- Multum (see the funnel plot in Appendix 5, available at www.

The robustness of the effect size to alternative statistical approaches or comparators in various sensitivity analyses suggests that this safety signal deserves further investigation.

Although one can never entirely rule out chance occurrence, there are potential alternative explanations for these findings. One possibility is that the participants in the placebo arms experienced a lower rate of serious adverse cardiovascular events because of failure of randomization. A systematic failure of randomization is unlikely, because Fluocinolone Acetonide Oil Ear Drops (DermOtic Oil)- FDA baseline characteristics of the participants were well balanced between groups.

However, despite achieving more than twofold higher rates of abstinence in the trials, which should potentially induce a cardiovascular benefit, the participants taking varenicline experienced an increased risk of serious adverse cardiovascular events. An earlier pooled analysis of data from clinical trials identified 22 serious ischemic and arrhythmic cardiac adverse events Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA 3940 patients allocated to receive varenicline compared with 4 such events among 1209 patients allocated to receive placebo (2.

Varenicline increases the chances of a successful (Gamunwx)- attempt by twofold Intravenoue with unassisted smoking cessation. The risk of additional serious adverse events associated with varenicline use includes the potential for serious Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA symptoms such as depressed mood, agitation and suicidal thoughts.

Long-term efficacy and safety data are lacking for all currently approved therapies, including bupropion. The limitations of our meta-analysis stem mainly from the quality of reported summary data. The trials enrolled different populations, evaluated different doses of varenicline and had different lengths of follow-up and proportions lost to follow-up. Our estimates are imprecise owing to the low event rates. None of the trials was adequately powered to detect individual differences in cardiovascular Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA. Although the Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA trials were double blinded, differences in ascertainment mediated by the cardiac symptoms of nicotine withdrawal is possible.

In the absence of (Hman) data, we could not assess for potential blinding failure, blinding biases or differences in ascertainment, or determine whether these events were immediate or (Gammunex).

Thus, (Gamundx)- could not determine whether the diagnoses were clinical diagnoses or confirmed by established diagnostic criteria. Finally, the applicability of our findings to smokers with unstable cardiovascular disease remains uncertain because these people were excluded from the trials. Our meta-analysis raises safety johnson builder about the potential for an increased risk of serious Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA cardiovascular events associated with the use of varenicline among tobacco users.

Despite the limitations of our analysis, our findings have potential regulatory and clinical implications. Drugs that receive priority review have limited safety data at the time of approval. Until such trials are conducted, clinicians should carefully balance the risk of serious cardiovascular events and serious neuropsychiatric adverse events associated with varenicline use against the known benefits of the drug on smoking cessation.

Immune Globulin Intravenous (Human) 10% (Gamunex)- FDA June 2011, the FDA announced the addition of a warning to the product label of Chantix (varenicline) about the small, increased risk of certain adverse cardiovascular events associated with the use of varenicline among smokers with cardiovascular disease.

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