PHARMACY

Pediatricians’ group recommends cholesterol drugs for select children

BY Drew Buono

CHICAGO The American Academy of Pediatrics is recommending that some children, as young as 8 years old, be given cholesterol-fighting drugs to prevent future heart problems, according to the Associated Press. The academy also recommended low-fat milk for 1-year-olds and wider cholesterol testing.

Stephen Daniels of the academy’s nutrition committee says the new advice is based on mounting evidence showing that damage leading to heart disease, the nation’s leading killer, begins early in life. It also stems from recent research showing that cholesterol-fighting drugs are generally safe for children, Daniels said.

The drug treatment would be aimed at children with overly high LDL cholesterol levels, along with other conditions like obesity and high blood pressure. But the first course of action, according to the academy, would be weight loss.

The academy also stated that pediatricians should be routinely checking the cholesterol of children with a family history of inherited cholesterol disease or with parents of grandparents who developed heart disease at an early age. Screening is also advised for children whose family history isn’t known and those who are overweight, obese or have other heart disease risk factors. The recommendation also said that screenings should start sometime after the age of two, but no later than the 10-years-old.

This is in comparison to the academy’s earlier advice, which said that cholesterol drugs should only be considered in children older than 10 after they fail to lose weight. Its previous cholesterol screening recommendations also were less specific and did not include targeted ages for beginning testing.

The low-fat milk recommendation was also very different from the academy’s early statement that low-fat milk for children up to age two was bad because saturated fats are needed for brain development. But, because of the growing concern over the health of the country and the startling figures surrounded by obesity, the academy decided to investigate ways to prevent health problems involving obesity early in life.

Currently, one-third of children in the United States are overweight and about 17 percent are obese, according to Jennifer Li, a Duke University children’s heart specialist.

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FDA to increase security for committee members in advisory meetings

BY Drew Buono

WASHINGTON The Food and Drug Administration is planning on beefing up its security at advisory committee meetings, in hopes of restoring order after an incident at a recent meeting, according to The Regulation Policy Market Report.

According to reports, an intoxicated speaker in the audience at a recent meeting began a threatening rant. This isn’t the first time there have been disturbances at an advisory committee, they usually occur when the drug in question is used to treat rare-or life-threatening disease.

While the FDA hasn’t made a formal announcement of the policy changes, Office of New Drug director John Jenkins discussed the new procedures at the Drug Information Association’s annual meeting last week.

“We have put in place some new measures to help improve security at meetings,” Jenkins said. “If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic, we may have additional security procedures.”

Those procedures include:

1)      Creating a physical barrier by roping off the committee from the public. The intent, Jenkins said, is “to put some separation between those who might become agitated in the audience and committee members.”

2)      Increasing the presence of security guards in the committee room—both in uniform and street clothes.

3)      Reading a statement at the start of the meeting about “good rules of behavior.”

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FDA approves Eisai’s Aciphex for ages 12 and up

BY Alaric DeArment

WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved Aciphex for treatment of gastroesophageal reflux disease in adolescents age 12 and older, Tokyo-based Eisai’s North America subsidiary announced Monday.

Aciphex, known generically as rabeprazole sodium, is available in 20 mg tablets for treating GERD for up to eight weeks.

Eisai discovered and developed the drug and promotes it in the United States with PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals.

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