The Food and Drug Administration (“FDA”) oversees the approval, regulation and safety of drugs and medical devices. Below are two drugs that the FDA has found safe and effective enough to approve for use.
Approval of First Nonprescription Oral Contraceptive
The FDA recently approved a pill to prevent pregnancy that can be obtained without a prescription. Historically, physicians had to write prescriptions for patients to obtain oral contraceptives. The drug, Opill, is progestin based.
Is the drug safe?
Laboratoire HRA Pharma manufactures Opill. For FDA approval, Laboratoire HRA Pharma had to demonstrate that consumers could use the product safely without oversight from physicians. Studies showed that consumers understood the instructions on the label and were able to use it by themselves.
What are side effects of the drug?
Notably, side effects include bleeding, headaches, abdominal pain, and nausea. A more detailed list of side effects and precautions can be found here.
The drug is not available yet, and the date of availability has not yet been determined. Importantly, it will be available without a prescription at drug stores, grocery stores, and online.
Approval of First Oral Treatment for Postpartum Depression
Postpartum depression is a major depressive episode that occurs after childbirth. Sometimes, it begins late in pregnancy.
Recently, the FDA approved the first oral treatment for postpartum depression. The drug, Zurzuvae, is the first of its kind. Until the approval of Zurzuvae, treatment for postpartum depression was only available through intravenous injection. Further, treatment was not widely available.
Is Zurzuvae safe?
The FDA deemed Zurzuvae safe enough to approve. Efficacy and safety of Zurzuvae was proven through two studies performed by the drug’s manufacturer, Sage Therapeutics., Inc. The studies followed women with postpartum depression for approximately six weeks. The participants were given Zurzuvae and/or placebos. The manufacturer showed that postpartum symptoms significantly improved after 14 days of use.
What are side effects of Zurzuvae?
Notably, side effects include drowsiness, dizziness, fatigue and urinary tract infections. Importantly, the manufacturer warns that Zurzuvae may cause suicidal thoughts, as well as other extreme injuries. A full list of side effects and precautions can be found here.