The deaths were reported to an FDA database of side effects for the medication. The reports of side effects in the database are commonly submitted by physicians and often lack information about how patients died and other medications they were taking at the time of their deaths.
It is unclear whether any of the deaths were directly caused by Symdeko.
Vertex told STAT that there is no evidence linking Symdeko to the reported deaths.
Despite the drugmaker’s defense, its share price dropped more than 4 percent on the news, according to STAT.
Symdeko was approved by the FDA last year to treat a specific genetic subtype of cystic fibrosis. It has a list price of $292,000 per year.
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