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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY January 2018 | Archived Issues

FDA Requires Safety Label Change for Prescription Cough and Cold Medicines

The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone in an effort to limit the use of these products to adults. Extensive review has shown that the risks of the medicines outweigh their benefits in children younger than 18. Healthcare professionals should be aware that the FDA is changing the age range for which prescription opioid cough and cold medicines are indicated. These products will no longer be indicated for use in children, and their use in this age group is not recommended.

The FDA website has more information.

FDA: Agency Urges to Watch for Signs of Hypersensitivity with Varubi Injectable Emulsion

Healthcare professionals are asked to be vigilant for signs of hypersensitivity or anaphylaxis in patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the post-marketing setting, some requiring hospitalization. Most reactions, however, have occurred within the first few minutes of administration.

The FDA website has more information.