FDA Approves Nexium for Use in Children Ages 1-11 Years The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). more...

FDA warns parents NOT to give cold or cough medicine to children under 2 FDA issues alert to parents: do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider. more...

House Fails To Override Veto of Children’s Health Bill The House of Representatives failed on Oct. 18, 2007 to override President Bush’s veto of legislation that would have expanded a federal health care program for children. more...

Medical Management of Vaccine Reactions in Children and Teens All vaccines have the potential to cause an adverse reaction. To minimize adverse reactions, patients should be carefully screened for precautions and contraindications before vaccine is administered. Even with careful screening, reactions can occur. These reactions can vary from trivial and inconvenient (e.g., soreness, itching) to severe and life threatening (e.g., anaphylaxis). If reactions occur, staff should be prepared with procedures for their management. more...

People who have a family history of allergic diseases may be more likely to have drug allergy Medications can cause unwanted reactions in many ways. Sometimes, it's a direct effect of the drug on the body. Drug hypersensitivity reactions occur when the immune system responds to a medication or to the biologic products that result when the body breaks down a medication. In some cases, the immune system tries to attack the substance, causing symptoms of the drug reaction. Drugs also can cause allergic reactions similar to those caused by bee stings or other allergenic substances. more...

A wide range of suspected ADRs are associated with fatalities in children The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome. more...

Smallpox vaccination is generally safe, but can result in untoward effects and adverse reactions Most are totally benign, if frightening in appearance. Some are serious, but treatable. A few, which rarely occur, are serious, life threatening and can be fatal. more...

Warning for Childeren and Adults Who May Be Prescribed ROACCUTANE For Acne A study reported in The Guardian today Tuesday 19th September 2006 again highlights the risk of depression caused by Roaccutane/ Accutane/ isotretinoin The UK regulator is the Medicines and Healthcare Products Regulatory Agency (MHRA)and has received 1,588 reports of suspected adverse events experienced by people taking the drug between licensing in 1983 and September this year. In 38 cases, people died and 25 of those were suicide. more...

Adverse Events in Children Approximately 70 000 children hospitalized in the United States experience an adverse event each year; 60% of these events may be preventable. more...

Adverse Events in North American NICUs More Frequent than Reported STANFORD, Calif-- A study led by Paul Sharek, MD, Chief Clinical Patient Safety Officer for Lucile Packard Children’s Hospital at Stanford, indicates that adverse events in neonatal intensive care units across North America occur more frequently and are more severe than previously reported. more...

Recent Colds Influence Adverse Respiratory Events after Surgery in Children For children undergoing general anesthesia for surgery or other procedures, the risks of several adverse respiratory events are greater if the child has recently had a cold or other upper respiratory infection (URI). more...

Adverse Drug Reactions Among Children Over a 10-Year Period Measures to improve detection and reporting of adverse drug reactions by all health care professionals should be undertaken, to enhance our understanding of the nature and impact of these reactions in children. more...

Adverse reactions to non-steroidal anti-inflammatory drugs Although NSAID hypersensitivity is thought to occur less commonly in children than adults, about 20-25% of the NSAID adverse reactions may occur in those 8-18 years old. Such adverse reactions in children tend to be manifest as facial angioedema rather than primarily respiratory syndromes. more...

Adverse Event Tracking as Mandated by the Best Pharmaceuticals for Children Act FDA's adverse event review plan more...

Antidepressant Use in Children, Adolescents, and Adults The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment more...

Acne, isotretinoin and suicidality Isotretinoin (Accure, Oratane, Roaccutane) is a retinoid derivative approved for the treatment of severe cystic acne which has not responded to other treatments including an adequate trial of antibiotics. Primarily because of this drug's known teratogenicity, prescription of isotretinoin in Australia is restricted to specialist physicians and dermatologists. more...

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