Generic asthma inhaler must be taken off market ¿ US FDA

(Bloomberg) — Patients using a generic inhaler for asthma that contains ozone-depleting chemicals will have to switch to products that may cost more, taste different and require cleaning, US regulators said.

Generic albuterol inhalers made by a unit of closely held Amphastar Pharmaceuticals Inc. will no longer be sold after this year because of environmental rules, said Badrul Chowdhury, director of the Food and Drug Administration's Division of Pulmonary and Allergy Products, in a conference call with reporters today.

The agency previously announced the products would be phased out, replaced by other albuterol medications that use a different propellent.

The generic product accounts for about 35 percent of the US market for albuterol inhalers, according to the FDA. Inhalers that don't contain chlorofluorocarbons, or CFCs, the environmentally damaging chemical, account for the rest of sales.

About 52 million prescriptions are written annually for albuterol inhalers in the US, Chowdhury said.

The newer inhalers "may taste and feel different than the CFC-propelled albuterol inhalers," the FDA said in a public health advisory posted on its Web site today. The devices must be cleaned to prevent blockage.

Patients will need to switch to brand-name products that are propelled by hydrofluoralkane, which doesn't damage the ozone layer according to the FDA.

Those products include: Teva Pharmaceutical Industries Ltd.'s Proair; Schering-Plough Corp.'s Proventil; and GlaxoSmithKline Plc's Ventolin. Patients could also use a similar medication called Xopenex, made by Sepracor Inc., according to the FDA.

CVS/pharmacy, a unit of CVS Caremark Corp., today was selling the generic version of albuterol by mail order for $25.99 and Proventil for $42.69.

Amphastar is based in Rancho Cucamonga, California.

Pregnancy asthma flare-ups tied to birth defects

NEW YORK (Reuters Health) — Women who experience asthma flare-ups during the first trimester of pregnancy are at increased risk for having a baby with a birth defect, according to a report in the Journal of Allergy and Clinical Immunology.

A first-trimester flare-up increased the odds of a malformation by 48 percent, note Dr. Lucie Blais and Amelie Forget, from Universite de Montreal and Hopital du Sacre-Coeur de Montreal. For major malformations, the risk increased by 32 percent.

"This study adds evidence to the necessity of keeping asthma under control during pregnancy to avoid exacerbations," the investigators write.

Several studies have looked at the link between asthma flare-ups and the risk of birth defects, the authors point out.

However, most of the studies were small and many of them compared asthmatic women who had flare-ups to non-asthmatic women, so the impact of the flare-up itself was unclear.

Through the use of three Canadian databases, the researchers were able to assess the occurrence of and risk factors for birth defects in 4344 pregnancies involving women with asthma.

Asthma flare-ups, which were assessed during the first trimester, were defined as a filling a prescription for steroid pills, an ER visit, or an asthma-related hospitalisation.

Overall, 9.2 percent of the babies had one or more defects and 6.0 percent of the infants had a major malformation. Defects of the skeleton and muscles were the most common followed by those involving the heart.

Overall, 12.8 percent of women with a flare-up had a child with birth defects compared with 8.9 percent of women without a flare-up.

"Because recent data are reassuring about the safety of (steroid inhalers) during pregnancy, health professionals should encourage pregnant women to continue their treatment at recommended doses once they know that they are pregnant to control their asthma symptoms, thus avoiding exacerbations and the need for (steroid pills)," the researchers emphasise.

For women, more children can mean fewer teeth

WASHINGTON (Reuters) — A German folk saying that means "every child costs the mother one tooth" may hold a lot of truth, research indicates.

Women who gave birth to more children tended to lose more teeth during their lives, regardless of whether they were rich or poor, US researchers found.

They examined data on 2,635 US women ages 18 to 64, sorting the nationally representative sample into three categories — low, middle and high socioeconomic status.

In the highest socioeconomic group, women with no children were missing on average less than one tooth, those with one child were missing about two teeth and those with four or more were missing about five teeth.

Among the women in the lowest socioeconomic group, those with no children on average were missing two teeth, those with one child were missing an average of three teeth and those with four or more were missing more than eight teeth.

The trend also held true in the middle socioeconomic group, said the researchers at New York University and Yale University in Connecticut.

"It seems that having more children is related to having fewer teeth," New York University dental professor Dr. Stefanie Russell, who led the research published in the American Journal of Public Health, said in a telephone interview.

"People might say that happens because women who are poor have more children and women who are poor are not going to be able to afford the dentist," she said. "But we found that it was true across all socioeconomic levels."

The study did not break down the results by race.

This was the first large US study to show such findings, Russell said.

Earlier studies elsewhere have shown similar results, in particular Scandinavian research from the 1980s.

Russell said she was not surprised to see that the old German saying — "Jedes kind kostet die mutter einen zahn" — had some truth to it. But the reasons are harder to figure, with a combination of factors most likely.

Women are more prone to gingivitis during pregnancy, when the response of the oral tissues to the bacteria in the mouth is altered, Russell said.

Gingivitis occurs when bacteria build up between the teeth and gums, causing inflammation and bleeding. Untreated, it can lead to more serious gum disease and eventually tooth loss.

In addition, Russell said women may be less likely to see a dentist while pregnant, perhaps in part because they want to avoid dental X-rays due to concern over radiation exposure.

Women with multiple children may also forgo their own dental care, possibly due to lack of money or time, Russell said.

Smoking and quitting problematic with arthritis

NEW YORK (Reuters Health) — Among people with rheumatoid arthritis, heavy smokers appear to have a greater loss of muscle mass than those who smoke fewer cigarettes or do not smoke, study findings suggest.

On the other hand, people with rheumatoid arthritis are prone to gain weight when they stop smoking, and this may negatively impact their quality of life, report Dr. Antonios Stavropoulos-Kalinoglou and colleagues.

"In any case, though, smoking is a bad habit for rheumatoid arthritis patients," said Stavropoulos-Kalinoglou of the Dudley Group of Hospitals NHS Trust, in West Midlands, UK.

Smokers with rheumatoid arthritis should couple smoking cessation with weight management and lifestyle counselling to counteract or minimise weight gain, he told Reuters Health.

Stavropoulos-Kalinoglou and colleagues compared measures of body mass, body fat, waist circumference, and muscle mass among 392 patients (290 female) who had rheumatoid arthritis for 4 to 18 years. They were 63 years old on average.

Overall, 69 participants were current smokers, 147 were ex-smokers, and 176 had never smoked, the researchers report in the medical journal Arthritis Research & Therapy.

Current smokers had significantly lower body mass and body fat than ex-smokers and never-smokers. The groups had similar overall muscle mass, with the exception of heavy smokers who had the lowest muscle mass values.

The investigators also found that 50 percent of ex-smokers were obese, compared with 39 percent of never-smokers and 30 percent of current smokers.

These findings should be confirmed in a study that follows the impact of smoking, smoking intensity, and smoking cessation on the body composition of people with rheumatoid arthritis over time, the investigators note.

Nonetheless, "it is very important for rheumatoid arthritis patients to stop smoking," Stavropoulos-Kalinoglou stressed. To achieve the most benefit from smoking cessation, he added, "they should also keep an eye on their weight."

Heart failure patients often overestimate survival

NEW YORK (Reuters Health) — Heart failure patients who are still mobile typically estimate that they will live three years longer than standard models predict they will, according to a report in the Journal of the American Medical Association.

"Because differences in perceived survival could affect decision making regarding advanced therapies and end-of-life planning, the causes of these discordant predictions warrant further study," Dr. Larry A. Allen, from the Duke Clinical Research Institute in Durham, North Carolina, and colleagues conclude.

"Prior studies have looked at end of life issues in heart failure," Allen told Reuters Health, "but few have looked specifically at the patients' perceptions of their chances for survival; and none have looked at how patients' predictions compare (with) statistically based model predictions."

The new study involved a survey of 122 patients in the Duke Heart Failure Disease Management Program. The subjects were interviewed between July and December 2004 and followed through February 2008.

The average patient age was 62 years and 47 percent of subjects were African American, the report indicates.

All of the patients had New York Heart Association class III or IV heart failure, indicating advanced disease.

The average patient-predicted life expectancy was 13.0 years, while the statistical model predicted that life expectancy was only ten years.

Factors associated with overestimating life expectancy included younger age, increased NYHA class, lower ejection fraction, and less depression.

"Not surprisingly, patients on average predicted that they would live longer than the models predicted," Allen said.

"Surprisingly, patients with advanced heart failure predicted they would live the same amount of time as patients with mild heart failure, despite the fact that heart failure severity is one of the strongest predictors of life expectancy."

Twenty-nine percent of patients died during an average follow-up period of 3.1 years, the report indicates. No association was seen between overestimations of survival and actual survival.

This "provocative" study identifies a disconnection between patient-predicted and statistical model-predicted life expectancy among ambulatory patients with heart failure," Dr. Clyde W. Yancy, from Baylor University Medical Center in Dallas, comments in a related editorial.

In so doing, the study presents challenges to physicians in evaluating the patient's need to know the prognosis; communicating prognostic information; and anticipating the consequences of such information for a patient with heart failure."