Posted On: May 31, 2011

Finally, FDA may require Tylenol dosing information for children 2 and under

An FDA advisory panel has voted 21-0 in favor of adding dosing instructions to Children’s Tylenol and other products containing acetaminophen for children between 6 months and 2 years.

Currently, the liquid formulas do not contain dosing information for children under 2. Panel members said the lack of information can lead parents to give their kids an incorrect dose of the drug.

Acetaminophen-related overdoses are most common among children younger than 2, and have increased over the past decade, according to FDA data. While safe when used as directed, acetaminophen has long been subject to warning labels because it can cause serious and even fatal liver damage when overused.

Dosing errors with children’s acetaminophen products accounted for 7,500 of the 270,165 emergencies reported to poison centers last year, according to the American Association of Poison Control Centers.

Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.

The panel also voted unanimously that medicines should include dosing information based on children’s weight, and to limit cup measurements to milliliters, because having both teaspoon and milliliter markings can cause confusion.

The proposed changes have been discussed at FDA meetings since the mid-1990s. FDA is not required to follow the recommendations of its advisory panels, though it often does.

Source: Associated Press

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Posted On: May 26, 2011

Atypical antipsychotic use high in children, study shows

Nearly half the children treated as inpatients for psychotic and mood disorders are given atypical antipsychotics, a new single-center study reports. About 44% of these young patients with a variety of conditions, ranging from psychosis to various mood and anxiety disorders, were treated with either first- or second-generation versions of the drugs, according to the study, which was recently presented at the American Psychiatric Association meeting in Honolulu.

To determine the prevalence of antipsychotic use and associated clinical characteristics - and to compare current use with past use - the researchers looked at 3,851 inpatients ages 5 to 17 who were seen at their facility between January 2000 and June 2010 for various diagnoses, including psychosis, behavioral disorder, depression, post-traumatic stress disorder (PTSD) and anxiety.

They found that antipsychotics were prescribed for 44.3% of patients, and that a higher proportion of those scrips were written for children (ages 5 to 12) than adolescents (ages 13 to 17) - 51.7% versus 41.7%.

Atypical prescribing varied by diagnosis, with prescriptions written for:

• 76% of psychosis patients (including schizophrenia and bipolar disorder)

• 45% of behavioral patients (including ADHD, panic disorder, and social phobia)

• 24% of depression patients

• 46% of PTSD patients

• 31% of anxiety patients

• 20% of patients with other diagnoses

The study authors expected atypical use to be most common in people with psychotic systems, but were surprised to see such high use of atypicals in behavioral diagnoses. The likely explanation is that the study focused on inpatients, who may exhibit more severe behavioral issues than outpatients.

Atypical antipsychotics were also more likely to be prescribed to males, nonwhites and those with a longer length of stay. Surprisingly, the general use of atypicals decreased over the study period, from 47% between 2001 and 2003 to 43.5% between 2006 to 2010.

The study was limited because it was done at a single center and because it lacked follow-up after discharge, and the study authors called for further study and the need for comparison with other institutions.

Source: Medpage Today

Study reference: Stevens M, et al "Current prescribing practices: antipsychotic use in children and adolescents" APA 2011; Abstract 12-41

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Posted On: May 19, 2011

May Flowers & Motorcycle Accident Safety Awareness

The following is a guest blog submitted by Michigan Motorcycle Accident Attorney Steven Gursten.

Finally, the sun is starting to show itself, which means more bikers on the roads. And since May is Motorcycle Safety Awareness Month, here are a couple points about safe operation.

The National Highway Traffic Safety Administration (NHTSA) has taken several steps to encourage drivers and motorcyclists to more safely share the road with each other.

One key factor in reducing the extent of injuries and reducing the risk of fatality is helmet use.

Based on research out of the NHTSA, motorcycle helmets saved 1,829 motorcyclists’ lives in 2008.

• Proper fitting motorcycle protective gear, including helmets, do not interfere with the rider’s vision or hearing.

Here are some quick tips for biker safety:

1. It should go without saying that you should never drink and drive.

Alcohol intoxication is responsible for 41 percent of all motorcycle fatal crash deaths in the U.S., according to the National Highway Traffic Safety Administration.

2. Whether the law requires it or not, wear a motorcycle helmet.

About 59 percent of motorcycle riders killed in 2007 were not wearing crash helmets.

3. Always ride defensively.

About 75% of all motorcycle accidents involve crashes with other motor vehicles; usually collisions with cars and trucks that fail to see and avoid the motorcycle operator.

4. You should never assume that other drivers will give you the right of way.

Overconfidence can cost you your life.

Operating a motorcycle takes great skill and coordination. Experience and safe driving practice are the best way to develop your ability to steer, brake and accelerate.

5. Never ride in the center of a traffic lane.

Following these simple tips might just be the difference between surviving a serious motorcycle collision and becoming the victim of a fatal motorcycle accident.

The views, opinions and positions expressed within this guest post are those of the author alone and do not represent those Patrick Malone & Associates, PC. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations.

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Posted On: May 17, 2011

Pediatricians recommend rear-facing car seats until age 2

The American Academy of Pediatrics has new advice for parents about how to buckle their children in their cars. In a new policy published last month, the AAP advises parents to keep their toddlers in rear-facing car seats until age 2, or until they reach the maximum height and weight for their seat. In addition, it recommends that children ride in a belt-positioning booster seat until they have reached 4’9” and are between 8 and 12 years of age.

Previously, the AAP advised parents to keep infants and toddlers rear-facing up to the limits of the car seat but also set a minimum of age 12 months and 20 pounds, which resulted in many parents turning the seat to face the front of the car when their child celebrated his or her first birthday.

“Parents often look forward to transitioning from one stage to the next, but these transitions should generally be delayed until they’re necessary, when the child fully outgrows the limits for his or her current stage,” said Dennis Durbin, MD, FAAP, lead author of the policy statement and accompanying technical report.

“A rear-facing child safety seat does a better job of supporting the head, neck and spine of infants and toddlers in a crash because it distributes the force of the collision over the entire body,” Durbin said. “For larger children, a forward-facing seat with a harness is safer than a booster, and a belt-positioning booster seat provides better protection than a seat belt alone until the seat belt fits correctly.”

While the death rate of children in motor vehicle crashes dropped by 45% between 1997 and 2009, it is still the leading cause of death for children ages 4 and older. Counting children and teens up to age 21, there are more than 5,000 deaths each year. And for each death, about 18 children require hospitalization and another 400 need medical treatment.

Source: The American Academy of Pediatrics

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Posted On: May 12, 2011

Stroller manufacturer calls for mandatory regulation after massive recall

Maclaren USA, the stroller manufacturer which issued a massive recall in November 2009, is calling for mandatory federal regulations of standards for strollers and global harmonization of stroller safety.

In a press release to announce results of the 2009 recall, Maclaren says that umbrella strollers “remain unregulated with tremendous risk to consumers who expect and assume otherwise" and notes that the stroller hazards that prompted the 2009 recall “were inherent not just to Maclaren products, but to nearly all umbrella-fold models,”

In November 2009, the Consumer Product Safety Commission (CPSC) and Maclaren jointly announced a voluntary recall of approximately 1 million Maclaren single and double strollers, citing the risk of fingertip amputation and laceration while the parent/caregiver is unfolding/opening the stroller.

Maclaren has provided a kit to cover the elbow joint on their umbrella strollers’ hinge mechanism, to avoid the potential hazard to a child when the operator is opening or closing the umbrella stroller. Maclaren says more than 300,000 U.S. consumers have ordered the kits in the past 18 months. However, the company also says it has received 37 new reports of fingertip injuries since the recall was issued.

According to the CPSC, there are approximately 11,500 stroller-related injuries each year, about 500 of which relate to finger injuries, including the hinge-related injuries associated with umbrella strollers.

SOURCE Maclaren USA, Inc.

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Posted On: May 2, 2011

New York creates fund for babies with brain damage from malpractice errors

New York state has created a new fund to pay medical expenses for infants who are neurologically damaged as a result of malpractice and other medical mistakes, but opponents say it means families will have to fight with state authorities to obtain treatments as their children age.

The fund, which is due to go into effect on Oct. 1, 2011, allows medical costs to be provided on an annual basis to injured parties. Parents or guardians can still pursue medical malpractice actions on the basis of emotional distress and other losses.

Between 150 and 200 babies are expected to qualify annually for the new fund, according to Jason Helgerson, Gov. Andrew Cuomo's chief Medicaid reform adviser. Participation in the fund is mandatory for those seeking either Medicaid recompensation or filing medical malpractice suits.

Helgerson says the fund will offer a more accurate means of providing care for injured infants because it isn’t subject to inaccurate estimates made by judges and juries trying to arrive at an accurate figure for health-care costs under the current malpractice award system.

But opponents of the fund maintain that the system was championed by health-care providers and will subject the families of neurologically damaged infants to on-going battles with the state for treatments as their children age.

Under the new statute, the fund describes "birth-related neurological injuries" as "an injury to the brain or spinal cord of a live infant caused by the deprivation of oxygen or mechanical injury occurring in the course of labor, delivery or resuscitation or by other medical services provided or not provided during delivery admission that rendered the infant with a permanent and substantial motor impairment or with a developmental disability."

Medical care will be decided on a case-by-case basis. In the event the fund is reduced to 20 percent or less of its annual size, the law contains a default stipulation allowing suits to be brought for medical expenses.

The establishment of the fund was included in a host of recommendations by a Medicaid Redesign Team (MRT) appointed by Gov. Cuomo to halt escalating Medicaid costs. Another recommendation from the task force called for capping noneconomic damages in medical malpractice cases at $250,000. That proposal was fiercely opposed and eventually scrapped.

Source: New York Law Journal

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