The History of Pharmacovigilance Infographic
April 23, 2017Beware Safety Risks Posed by ‘Off-Label’ Drug Use
April 25, 2017The FDA has issued a Safety Alert restricting the use of codeine and tramadol in children. Children under 12 years and some adolescents younger than 18 years (especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems) should not use medicines containing these drugs because of increased medical risks, including slowed or difficult breathing and death. The FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants, including excess sleepiness, serious breathing problems, or death.
The FDA is requiring several labeling changes to all prescription medicines containing these drugs. Health care professionals should be aware that tramadol and single-ingredient codeine medicines are FDA-approved only for use in adults, and should consider recommending OTC or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years. The FDA also reminds health care professionals that cough is often secondary to infection and not serious, usually resolving on its own and not requiring treatment.
FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond the 2013 FDA restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. FDA is now adding:
- FDA’s strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
- A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
- A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
- A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
