Tag: Communication
Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication – Serious Adverse Events From Accidental Ingestion by Children
Accidental ingestion of active ingredients tetrahydrozoline, oxymetazoline, or naphazoline may cause serious and life-threatening adverse events. MedWatch Safety Alert RSS Feed
Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication – Reports of Serious Tissue Damage
Incorrect use can cause hemorrhaging and soft tissue, muscle, and vital organ damage, which can lead to serious injury and/or death. MedWatch Safety Alert RSS Feed
Mirapex (pramipexole): Drug Safety Communication – Ongoing Safety Review, Possible Risk of Heart Failure
FDA currently evaluating analysis of randomized clinical trials and epidemiologic studies. MedWatch Safety Alert RSS Feed
FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
The U.S. Food and Drug Administration (FDA) is alerting the public that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied. What’s [...]
Over-The-Counter Topical Muscle and Joint Pain Relievers: Drug Safety Communication – Rare Cases of Serious Burns
Some of the burns had serious complications requiring hospitalization MedWatch Safety Alert RSS Feed
FDA Drug Safety Communication: FDA recommends against use of Revatio in children with pulmonary hypertension
The U.S. Food and Drug Administration (FDA) is recommending that Revatio (sildenafil) not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH; high pressure in the blood vessels leading to the lungs). What’s New: Drugs RSS Feed
Revatio (sildenafil): Drug Safety Communication – Recommendation Against Use in Children
Recent long-term clinical pediatric trial showed children taking a high dose of Revatio had a higher risk of death than children taking a low dose. MedWatch Safety Alert RSS Feed
Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication – Risk of Rare, But Life-Threatening Adverse Events or Death
Ultra-rapid metabolizers are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal. MedWatch Safety Alert RSS Feed
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure
ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death. MedWatch Safety Alert RSS Feed
FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death
The U.S. Food and Drug Administration (FDA) is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome What’s New: Drugs RSS Feed
