2 Asthma Inhalers May be Removed from Market

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2 asthma inhalers likely to be pulled

http://www.startribune.com/lifestyle/health/36012399.html?

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Last update: December 11, 2008 - 7:33 PM

" Government health advisers recommended restrictions Thursday on some

long-acting asthma drugs, although not Advair, a top-selling

medication.

Outside experts advising the Food and Drug Administration (FDA) said

Foradil and Serevent no longer should be used for asthma. But they

said the benefits of the more widely used Advair and Symbicort

clearly outweigh the risks.

Each contains an ingredient that relaxes muscles around stressed

airways. But that may mask symptoms that can trigger life-threatening

asthma attacks. Advair and Symbicort contain a second ingredient that

reduces inflammation inside breathing passages and may help patients

avoid such problems.

For all four drugs, the FDA's drug safety experts had recommended

restrictions, including not using them to treat asthmatic children.

The agency's respiratory specialists disagreed, saying the risks were

manageable.

With its own experts deadlocked, the FDA called in an unusually large

panel of nearly 30 outside advisers.

The medical and scientific experts unanimously said Advair and

Symbicort should continue to be used with all patients, including

children.

The FDA usually follows the recommendations of its outside advisers.

About 22 million people in the United States have from asthma, which

claims nearly 3,600 lives. Children account for nearly one of every

three patients.

STERN WARNING FOR COLONOSCOPY DRUGS

Federal health officials will add the sternest safety warnings

available to drugs used before colonoscopies, following reports of

kidney damage.

The FDA said it has received more than 20 reports of a serious form

of kidney failure among patients taking the bowel-cleansing drugs,

known as oral phosphate products.

The new warning label will apply to Visicol and OsmoPrep -- both

prescription tablets made by Salix Pharmaceuticals. The label says

the drugs should be used with caution in patients older than 55,

those who suffer from dehydration and kidney disease, and those who

take medications that affect the kidneys.

GOOD FOR BONES ...AND BREAST CANCER

There is fresh hope that a drug that strengthens bones might also

fight breast cancer.

Women who were given the drug, Zometa, as part of their initial

treatment had greater tumor shrinkage and were less likely to need

radical surgery, according to a preliminary study reported at a San

conference.

In June, doctors were stunned when a big study found that Zometa --

given to prevent bone loss caused by certain cancer treatments --

also greatly cut the risk that cancer would recur in women who

developed the disease before menopause.

Cancer specialists are eagerly awaiting the results of a second study

testing Zometa in 3,360 women who had breast cancer after menopause,

which is much more common.

NEWS SERVICES

Government health advisers recommended restrictions Thursday on some

long-acting asthma drugs, although not Advair, a top-selling

medication.

Outside experts advising the Food and Drug Administration (FDA) said

Foradil and Serevent no longer should be used for asthma. But they

said the benefits of the more widely used Advair and Symbicort

clearly outweigh the risks.

Each contains an ingredient that relaxes muscles around stressed

airways. But that may mask symptoms that can trigger life-threatening

asthma attacks. Advair and Symbicort contain a second ingredient that

reduces inflammation inside breathing passages and may help patients

avoid such problems.

For all four drugs, the FDA's drug safety experts had recommended

restrictions, including not using them to treat asthmatic children.

The agency's respiratory specialists disagreed, saying the risks were

manageable.

With its own experts deadlocked, the FDA called in an unusually large

panel of nearly 30 outside advisers.

The medical and scientific experts unanimously said Advair and

Symbicort should continue to be used with all patients, including

children.

The FDA usually follows the recommendations of its outside advisers.

About 22 million people in the United States have from asthma, which

claims nearly 3,600 lives. Children account for nearly one of every

three patients. "