Federal regulators said they decided to extend the warning after finding 35 cases of the amniotic fluid problem reported to the FDA and reviewing similar examples in published research. Use of the pain relievers reduced amniotic fluid in as little as two days, in some cases, the FDA said. Generally, the problem reversed itself three to six days after women stopped taking the medications.
Women who aren't sure if their medication contains the drugs should talk to a doctor or a pharmacist, the agency said.
The industry group for makers of over-the-counter medicines said companies “will work with FDA to update labels accordingly,” in an emailed statement.