Possible risks from taking the drug include accidental poisoning and addiction
Concomitant use of central nervous system-depressant drugs listed for 58.4 percent of off-label gabapentin visits
Request follows reports that Biogen and the FDA held off-the-books meetings before the drug's approval that may have violated FDA protocol
Major changes to prescribing instructions are rare, especially so soon after approval; change could curb the drug's use
Donanemab has already received a 'breakthrough therapy' designation from the FDA
Several experts have said the available evidence about Aduhelm raises significant doubts about its effectiveness
Agency says it has granted approval on the condition that drug maker Biogen conduct a new clinical trial
8-mg dose of naloxone hydrochloride nasal spray now approved with 2-mg and 4-mg doses