Schering-Plough’s Comments
Julie Lux, a spokeswoman for Schering-Plough, tells WebMD:
“We support the FDA’s decision to adopt new prescribing information regarding PDE-5 inhibitors [Viagra, Cialis or Levitra] and NAION. In addition, we continue to confer with other regulatory authorities worldwide and we constantly monitor product safety reports and work closely with worldwide regulatory authorities including the FDA to ensure that appropriate product information is shared with physicians and their patients.
“We recently received one spontaneous report of NAION occurring in a man taking Levitra,” Lux continues.
“It is not possible to determine whether this event is related to the use of Levitra, to the patient’s underlying risk factors for developing NAION, to a combination 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 relationship to use of PDE-5 inhibitors including Levitra has not been established, we agree with [the] FDA that the inclusion of this new safety information in all PDE-5 labels will further assist physicians in making important treatment decisions for their patients with ED [erectile dysfunction],” says Lux.
Related posts:
- FDA’s Advice for Patients – Cialis, Viagra, Levitra
- FDA’s Statement
- Viagra and Blindness
- Brief Amnesia After Taking Levitra?
- Viagra, Cialis, Levitra Information Sheet Warns o f Sudden Hearing Loss
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