Regulators in the USA have declared that following a safety review, it has found no risk of heart trouble connected to Boehringer Ingelheim and Pfizer’s chronic obstructive pulmonary disease drug Spiriva.
The US Food and Drug Administration’s review began after acting on claims from a meta-analysis published in the Journal of the American Medical Association in September 2008 which argued that Spiriva Handihaler (tiotropium) is associated with a significantly increased risk of cardiovascular death, myocardial infarction or stroke. However, the companies strenuously denied the link and the agency issued early communications about an ongoing safety review agreeing with them.
That review is now complete and the FDA says “the available data do not support an association” between the use of Spiriva and “an increased risk for these serious adverse events”. The agency added that it is advising healthcare professionals to continue to prescribe the drug, developed by Boehringer and marketed by Pfizer, as recommended on the label.
Chantix lawsuits
There was less good news for Pfizer after it emerged that three personal injury lawsuits have been filed against the firm, claiming that its smoking-cessation drug Chantix/Champix (varenicline) caused patients on the drug to attempt or successfully commit suicide.
The lawsuits, filed in New York State Supreme Court, claim that Pfizer “intentionally, recklessly, and/or negligently concealed, suppressed, omitted, and/or misrepresented” the risks associated with the drug, including depression and suicidal thoughts. In July last year the FDA told Pfizer to include a boxed warning on Chantix about the risk of “serious mental health events”.
