IPLEDGE program
Although the goal of the program is to prevent pregnancies of women who take the drug, male patients must also participate in anti-pregnancy restrictions, primarily due to fears that male isotretinoin users might share their prescriptions with females without their physicians' knowledge. There has been no link to birth defects from Accutane associated with males using the drug, though male sexual dysfunction has been suggested by one study. As this has not been conclusively proven, this is not acknowledged as a side effect in the official literature accompanying the medication.
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.