Science & Research
FDA Pediatric Safety Communications
* Not currently marketed in the U.S.
Safety Issue and Web Address
|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 improving exercise 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 as Persistent 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)|
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
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)|
|Sep. 15, 2010||Valcyte (valganciclovir hydrochloride)|
|July 29, 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.