FDA: Birth Control Chemical Won't Inhibit STDs
The chemical nonoxynol 9 (N9), used in many vaginal contraceptives and spermicidal products, does not protect users from infection from sexually transmitted diseases, including AIDS, the U.S. Food and Drug Administration said Tuesday.
The agency said it mandated that all over-the-counter products containing N9 -- including contraceptive gels, foams, films, or inserts -- include the warning on their labels.
"FDA is issuing this final rule to correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection," Dr. Janet Woodcock, the agency's deputy commissioner for scientific and medical programs, said in a prepared statement.
The FDA warned that N9 can irritate the vagina and rectum, increasing the risk of contracting HIV/AIDS from an infected partner. It also warned that people should not use any product containing N9 if the user or partner is infected with the AIDS virus.
"Consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly," the FDA said.
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Canada Confirms New Mad Cow Case
Canada has confirmed another case of mad cow disease, found in a 13-year-old animal from an Alberta farm. It's the 11th case of the disease in the country since the first case was discovered in May 2003, the Canadian Press reported.
The cow in this latest case was born before Canada implemented new feed controls in 1997. No part of the cow's carcass entered the human or animal food chains, said a news release on the Canadian Food Inspection Agency Web site.
This new case of mad cow disease was identified by Canada's national monitoring program, which focuses on cattle most at risk. The program has tested about 190,000 cattle since 2003, the CP reported.
Canada's international standing as a country with a controlled risk for mad cow disease will not be affected by this new case, according to the food and inspection agency.
According to the U.S. Department of Health and Human Services, mad cow disease (BSE, or bovine spongiform encephalopathy) is a fatal disease that causes progressive neurological degeneration in cattle. Creutzfeldt-Jakob disease (CJD) is a rare disease that occurs in humans that's similar to mad cow. While it's not certain how mad cow-like disease may spread to humans, evidence indicates that humans may acquire it after consuming BSE-contaminated cattle products.
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FDA Approves New Hypertension Drug
A new beta blocker called Bystolic (nebivolol) has been approved for treatment of high blood pressure (hypertension), the U.S. Food and Drug Administration announced Monday.
The approval was based on findings from four studies in which more than 2,000 people received Bystolic. The drug's efficacy was similar to that of other FDA-approved beta blockers. Common side effects experienced by people taking Bystolic included headache, fatigue, dizziness and diarrhea.
Beta blockers are a well-established class of medications that lower blood pressure by reducing the force with which the heart pumps blood. Nearly one in three American adults has high blood pressure, which increases the risk of stroke, heart failure, heart attack, kidney failure and death.
"High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," Dr. Douglas C. Throckmorton, FDA's deputy director of the Center for Drug Evaluation and Research, said in a prepared statement. "Bystolic offers a new treatment option for people who need to control their high blood pressure."
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Taking Blood Pressure Pills at Night May Offer Benefits: Study
For certain people, it may be better to take high blood pressure medications at night instead of in the morning, says an Italian study in the December issue of the American Journal of Kidney Diseases.
The researchers concluded that this simple change may help normalize blood pressure patterns in people at increased risk from heart and kidney disease, the Canadian Press reported.
In healthy people, blood pressure drops by 10 percent to 20 percent during sleep. Scientists suspect that this may occur in order to give arteries a bit of rest. People with hypertension who don't experience this blood pressure dip at night are more likely to develop serious heart disease than other hypertension patients who do experience the dip.
People with chronic kidney disease are most likely to be "non-dippers," which increases their risk of worsening kidney damage and heart disease.
In this study, 32 non-dippers with kidney disease started taking a high blood pressure drug at night instead of in the morning, the CP reported. Within two months, nearly 90 percent had turned into dippers, with an average seven-point drop in nighttime blood pressure. There were also signs of improved kidney function. The patients experienced no side effects or increases in daytime blood pressure.
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European Commission Approves Once-a-Day HIV Pill
European regulators have approved the once-a-day HIV pill Atripla, which combines three existing drugs (efavirenz, tenofovir and emtricitabine). The pill will soon be available to HIV patients in a number of European countries, BBC News reported.
Atripla was approved in the United States in July last year and is now given to about half of all newly diagnosed HIV patients.
Early HIV drug therapy required patients to take as many as 30 pills on an empty stomach at different times, BBC News reported. That had been reduced to just several pills a day for newly -diagnosed HIV patients. This new pill further simplifies the mediation regimen.
Atripla was developed through a collaboration of three drug makers -- Gilead Sciences, Bristol-Myers Squibb and Merck.
"This is a big advance for patients. It almost normalizes HIV," Dr. Simon Portsmouth, a leading HIV consultant, told BBC News. "They can just take this pill before they go to bed at night, and it doesn't take over their whole life."
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Canadian Reactor Resumes Production of Medical Isotopes
A Canadian nuclear reactor that's a major global source of radioisotopes resumed operations Sunday after being shut down for about a month. The shutdown led to a shortage of medical isotopes, which are essential for medical imaging and diagnostic scans for cancer, heart conditions and fractures.
Because they have a short shelf life, it isn't possible to stockpile radioisotopes.
The National Research Universal reactor in Chalk River, Ont. is producing new supplies of medical isotopes, which should be ready for distribution within a few days, CBC News reported.
The facility was shut Nov. 18 for a week of maintenance, but the Canadian Nuclear Safety Commission wouldn't let it resume operations until a number of safety issues were addressed. Last week, Canada's Parliament passed legislation to get the reactor back online.
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