Isotretinoin
Isotretinoin is a teratogen; there is about a 20–35% risk for congenital defects in infants exposed to the drug "in utero", and about 30–60% of children exposed to isotretinoin prenatally have been reported to show neurocognitive impairment. Because of this, there are strict controls on prescribing isotretinoin to women who may become pregnant and women who become pregnant while taking isotretinoin are strongly advised to terminate their pregnancies.
Ceftazidime/avibactam
Avycaz is a prescription-only medication, which was fast-tracked by the FDA due to the shortage of drugs that effectively circumvent the resistance problem. One of the active pharmacological ingredients, ceftazidime, has long been proven to be safe, which allowed the FDA to expedite its approval. The FDA relegated its use to only those patients who are refractory to other treatments because of the limited clinical safety data and also to prevent prescribers from overusing this therapy if other effective treatment exists. Additionally, the price gap between traditional therapy and Avycaz is quite large. The wholesale acquisition cost (WAC), which is the price the manufacturer will set for the wholesaler to purchase the drug, for Avycaz is $2,850 for ten 2 g vials. While this is not the price the patient pays, the cost of a single day of treatment with Avycaz is more than a full 14-day regimen of currently used medications because of the availability of generic alternatives. This financial pressure should help with the FDA regulation in restricting its use.