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News 28/09/2544


FINAL RULE BANS CERTAIN OTC COUGH-COLD COMBINATION DRUGS
The US Food and Drug Administration (FDA) issued a final rule banning over-the-counter combination oral drug products that pair a bronchodilator with an analgesic, analgesic-antipyretic, anticholinergic, antihistamine, antitussive or stimulant active ingredient.

BREAST CANCER MORTALITY IS NOT INCREASED IN HRT USERS
Women who take hormone replacement therapy (HRT) are at increased risk of developing breast cancer, but they are not more likely to die from the disease than women who do not take HRT.


Final Rule Bans Certain OTC Cough-Cold Combination Drugs


WASHINGTON (Reuters Health) Sept 26 - The US Food and Drug Administration (FDA) issued on Wednesday a final rule banning over-the-counter combination oral drug products that pair a bronchodilator with an analgesic, analgesic-antipyretic, anticholinergic, antihistamine, antitussive or stimulant active ingredient.

The agency said that it knows of no currently marketed OTC drugs that meet that description.

Oral bronchodilator active ingredients include ephedrine and related substances. The FDA has in the past voiced strong concerns about weight-loss dietary supplements that combine ephedrine/ephedra with stimulants like caffeine. The new rule — while applying only to cough, cold and allergy drugs — serves to fortify the agency's position that such ingredient combinations may be unsafe.

The final rule will take effect 30 days after its scheduled publication in Thursday's Federal Register. It is part of the FDA's ongoing review of OTC products.


Breast Cancer Mortality Is Not Increased in HRT Users


LONDON (Reuters Health) Sept 21 - Women who take hormone replacement therapy (HRT) are at increased risk of developing breast cancer, but they are not more likely to die from the disease than women who do not take HRT, doctors said on Thursday.

Dr R. Prasad and colleagues from University Hospital South Manchester told the 7th Nottingham International Breast Cancer Conference that prior HRT use does not adversely affect the breast cancer survival rates in women.

The researchers studied 589 patients diagnosed with first-incident screen-detected breast cancer between 1991 and 1997. Of these, 417 had never used HRT, while 172 had. The node status and tumour size did not differ between HRT users and non-users.

At 10-year follow-up, Dr. Prasad and colleagues found that 91% of those who used HRT were still alive after 10 years compared with 88% of those who had never taken HRT.

"Overall, screen-detected cancers have good prognosis," Dr. Prasad told conference participants. "Prior HRT use does not adversely affect survival after diagnosis of breast cancer."


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