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Such publication commonly leads to urgent calls to take immediate regulatory action, without acknowledgment of potential pitfalls in the interpretation of data from meta-analyses and pooled analyses, such as those encountered in the tiotropium evaluation.
FORBES: FDA Asks For "Restraint" On Drug Safety Worries
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Dr Harvey, who is also a respiratory consultant at Southmead Hospital, said it remained to be seen whether tiotropium should have a use for all sufferers or targeted at those with moderate to severe symptoms.
BBC: Drug transforms life for lung patients
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The main point of the article is to explain why FDA is not taking action against Spiriva (generic name: tiotropium), a treatment for chronic obstructive pulmonary disorder sold by Boehringer Ingelheim and Pfizer, despite a meta-analysis that raised concerns.
FORBES: FDA Asks For "Restraint" On Drug Safety Worries