New Liquid Drug Guidelines Aim to Prevent Drug Overdoses

Federal drug regulators have issued new guidelines for drug manufacturers that are designed to prevent confusion over the recommended doses for over-the-counter (OTC) liquid drugs. 

The FDA issued final guidance for liquid drugs on May 4, which the agency hopes will help reduce accidental drug overdoses and other medication errors.

The guidance calls for manufacturers to always supply dosage dispensing devices, such as cups and droppers with any liquid OTC drug. It also calls on drug makers to make sure the medication dispensers use the same units of measurement as the dosage recommended on the drug label.

The new guidance is non-binding and drug manufacturers are not forced by law to follow them. However, they will be the recognized standard for OTC liquid drugs.

The guidance followed a number of drug warnings and recalls in recent years where the FDA determined that consumers were confused by the dosing instructions or drug dispensing devices supplied with liquid OTC drugs, particularly those approved for children.

In June 2010, the FDA issued a vitamin D infant overdose risk alert after it was discovered that the droppers supplied with some of the supplements could hold a much greater amount than the recommended dosage, and some parents filled the syringes up, putting their infants at risk of a vitamin D overdose. An overdose of vitamin D can cause nausea, vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, fatigue and may also lead to kidney damage.

At the time, the FDA sent a letter to the vitamin supplement industry calling on them to limit the size of the droppers so that they could only contain the maximum safe dosage.

In addition to supplying the dispensing device and making sure it is marked with the same units of measurement used to determine the dosage of the liquid OTC drug, the FDA guidance also calls for drug manufacturers to ensure that the dose delivery devices are only used with the drug they were packaged with. The FDA also wants manufacturers to make sure that the measurement markings on the devices are clearly visible both when empty and when filled with medication.