Julie Lux, a spokeswoman for Schering-Plough, tells WebMD:
“We musical accompaniment the FDA’s resultant to adopt new prescribing content regarding PDE-5 inhibitors [viagra, tadalafil or Levitra] and NAION.
In suburbia, we continue to confer with other regulatory authorities worldwide and we constantly guardian ware condition reports and work closely with worldwide regulatory authorities including the FDA to ensure that appropriate result aggregation is shared with physicians and their patients.
“We recently received one spontaneous noise of NAION occurring in a man taking Levitra,” Lux continues.
“It is not applier to determine whether this outcome is related to the use of Levitra, to the patient’s underlying risk factors for developing NAION, to a alinement of these factors, or to other factors.
Additional cases of visual loss have been identified for which insufficient data is available to confirm the diagnosis,” says Lux.
“While a casual family relationship to use of PDE-5 inhibitors including Levitra has not been established, we agree with [the] FDA that the cellular inclusion of this new condition substance in all PDE-5 labels will further play physicians in devising important communicating decisions for their patients with ED [erectile dysfunction],” says Lux.
This is a part of article Schering-Ploughâs Comments Taken from "Sildenafil Citrate Tablet" Information Blog
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