Science & Research

FDA Pediatric Safety Communications

Date Product(s) Safety Issue and Web Address

Apr. 27, 2017

General Anesthetic and Sedation Drugs Alert informing health care professionals and the public about the approval of labeling changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include, a new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years. Addition of information to the sections of the labels about pregnancy and pediatric use to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning. General anesthetic and sedation drugs are necessary for patients, including young children and pregnant women, who require surgery or other painful and stressful procedures. In the U.S., surgeries during the third trimester of pregnancy requiring general anesthesia are performed only when medically necessary and rarely last longer than 3 hours. We are advising that in these situations, pregnant women should not delay or avoid surgeries or procedures during pregnancy, as doing so can negatively affect themselves and their infants. Similarly, surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary. Consideration should be given to delaying potentially elective surgery in young children where medically appropriate.
Apr. 20, 2017 Codeine and tramadol containing products Alert highlighting the restricted use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. FDA is contraindicating codeine for use to treat pain or cough and tramadol for use to treat pain in children younger than 12 years. An additional contraindication has been added to the tramadol label for treatment of pain in children younger than 18 years who have had surgery to remove the tonsils and/or adenoids. A new warning has been added to the codeine and tramadol labels to recommend against 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. The warning for mothers has been strengthened to say that breast feeding is not recommended when taking codeine or tramadol medicines due to the risk of severe adverse reactions in breastfed infants..
Jan. 27, 2017 Hyland's belladonna-containing homeopathic teething products Alert warning health care professionals and the public to stop using homeopathic teething tablets marketed by Hyland’s. FDA’s analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.  Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.
Nov. 17, 2015 Iodine-containing Contrast Agents (Cystografin,
MD-76R,Cholografin Meglumine,Visipaque, Omnipaque, Isovue,Ultravist, Conray, Optiray,Hexabrix, Oxilan)
Alert informing health care professionals and public about rare cases of underactive thyroid in infants after use of iodine- containing contrast media (ICM) for X-rays and other medical imaging procedures. In all cases, the infants were either premature or had other serious underlying medical conditions. Parents and caregivers are advised to contact their baby’s health care if they have questions or concerns about their baby receiving an ICM product.
Sept. 21, 2015 Ultram, Ultram ER, Conzip, and generics (tramadol) Ongoing safety review to evaluate the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. Tramadol is not FDA-approved for use in children. Health care professionals should consider prescribing alternative FDA-approved pain medicines for children.  Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention.
July 16, 2015 Proglycem (diazoxide) Alert warning health care professionals about a serious lung condition called pulmonary hypertension in infants and newborns that occurs after receiving diazoxide for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after the drug was stopped.
June 26, 2014 Oral viscous lidocaine 2% solution Alert informing health care professionals and the public about a new Boxed Warning for the product labeling. The product should not to be used to treat infants and young children with teething pain. The oral viscous lidocaine solution is not approved for this indication and can cause death, problems with the heart, severe brain injury and seizures.
June 25, 2014 Over- the-counter acne products (such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean&Clear, and as store brands) Alert warning health care professionals and the public about the rare but serious and potential life threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives and itching.
Mar. 31, 2014 Revatio (sildenafil) Update clarifying the strength of the warning communicated in the revised product label in August 2012 (see below). The warning stated that “use of Revatio, particularly chronic use, is not recommended in children”. This recommendation was not intended to suggest that Revatio should never be used in children. This warning should not be interpreted as a contraindication. Revatio may be used with close monitoring in individual children when other treatment options are limited and benefit outweighs the risk.
Dec. 17, 2013 Concerta (methylphenidate hydrochloride), Daytrana (methylphenidate), Focalin and Focalin XR (dexmethylphenidate hydrochloride), Metadate CD and Metadate ER (methylphenidate hydrochloride), Methylin and Methylin ER (methylphenidate hydrochloride), Quillivant XR (methylphenidate hydrochloride), Ritalin, Ritalin LA, and Ritalin SR (methylphenidate hydrochloride) Alert warning health care professionals and the public about the rare but serious risk of priapism (prolonged and sometimes painful erections) with methylphenidate products used to treat attention deficit hyperactivity disorder (ADHD). Notably, the majority of the 15 cases of priapism reported to the FDA between 1997-2012 occurred in males less than 18 years of age. Some patients were hospitalized for treatment, including two who required surgical intervention: one with shunt placement and another with needle aspiration of the corpus cavernosum.
Feb. 26, 2013 Sensipar (cinacalcet hydrochloride) Alert informing healthcare professionals that FDA suspended all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after a recent death of a 14-year-old patient in a trial. FDA continues to gather information on the circumstances surrounding the patient’s death.
Feb. 20, 2013 Codeine and Codeine-Containing Products Update informing health care professionals and the public about a new Boxed Warning and Contraindication in the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and /or adenoidectomy.
Oct. 25, 2012 Over the-counter tetrahydrozoline, oxymetazoline, or naphazoline containing eye drops and nasal decongestant sprays Alert informing health care professionals about serious adverse events from accidental ingestion of over-the-counter redness-relief eye drops or nasal decongestant sprays by children 5 years of age and younger. These products are sold under various brand names, as generics, and as store brands (see List of Products in the safety communication).
Aug. 30, 2012 Revatio (silfenadil) Alert informing healthcare professionals not to prescribe sildenafil to children (ages 1 through 17 years) for pulmonary arterial hypertension (PAH) due to higher risk of death with high doses and low doses are ineffective at improvingexercise ability.
Aug. 15, 2012 Codeine and Codeine-Containing Products Alert informing healthcare professionals and the public about the risk of rare, but life-threatening adverse events or death on the use of codeine in certain children after tonsillectomy and/or adenoidectomy.
Dec. 14, 2011 Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone) Update informing healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known asPersistent Pulmonary Hypertension of the Newborn (PPHN).
Nov. 3, 2011 Tumor necrosis factor (TNF) blockers [Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab) Update informing healthcare professionals and the public about the ongoing safety of Tumor Necrosis Factor (TNF) blockers and malignancies (cancer) in children, adolescents, and young adults (30 years of age or younger).
Aug. 4, 2011 Recombinant Human Growth Hormone (somatropin) Update informing the public about the ongoing safety review of human growth hormone (somatropin) and possible increased risk of death.
July 11, 2011 Tamiflu (oseltamivir phosphate) for Oral Suspension Alert informing healthcare professionals of important product safety changes made to reduce the possibility of prescribing and dosing confusion that can lead to medication errors.
May 20, 2011 SimplyThick Alert informing healthcare professionals and the public not to feed SimplyThick to infants born before 37 weeks gestation because of the risk of necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
Mar. 8, 2011 Kaletra (lopinavir/ritonavir)
New warning to the product labeling of Kaletra (lopinavir/ritonavir) oral solution that use should be avoided in preterm infants in the immediate postnatal period because of the possible toxicity associated with the product.
Dec. 14, 2010 Tessalon (benzonatate)
Alert notifying the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose.
Sep. 15, 2010 Valcyte (valganciclovir hydrochloride) Alert informing healthcare professionals about new pediatric dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients.
July29, 2010 Evamist (estradiol transdermal spray) Ongoing safety review of adverse effects including premature puberty from Evamist in children who may have been unintentionally exposed to the drug through skin contact with women using this product. FDA has also received reportes of inadvertent exposure in pets.
June 15, 2010 Vitamin D Supplement Products Alert advising that some liquid Vitamin D supplement products sold with droppers could allow parents to accidentally give harmful amounts of Vitamin D to their infant.
June 2, 2010 Serevent Diskus (Salmeterol); Foradil Aerolizer (Formoterol); Foradil Certihaler* (Formoterol); Advair Diskus (Salmeterol/Fluticasone); Advair HFA (Salmeterol/Fluticasone); Symbiort (Formoterol/Budesonide); Brovana (Arformoterol); Perforomist (Formoterol) Update highlighting information about appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs).

* Not currently marketed in the U.S.



Page Last Updated: 05/08/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English