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At least 73 records · Page 4Linked to original sources
PubMed1995

Special report: the truth about condoms. Restrictive label could impede plastic condom sales.

You walk into a drugstore to buy a package of plastic condoms. You happen to notice the label says that no one's sure how well they protect you from pregnancy or sexually transmitted diseases (STDs) like AIDS. Then, the label indirectly points you in the direction of latex condoms. What would you do? Some observers familiar with the condom industry speculate that the restrictive labeling carried on each package of the new plastic condoms for men will not interfere with consumers' purchasing decisions. Other predict an instant replay of the situation faced by makers of the polyurethane Reality female condom: A lack of data on pregnancy rates and STD rates resulted in a label touting latex as a superior product, which in turn caused an onslaught of negative press about the first plastic condom. The US Food and Drug Administration, finding itself in a similar position with approving plastic condoms for men, recently released interim labeling to be followed by all manufacturers who want to sell the new male condoms. Essentially, the manufacturers must point out on the front of the condom box that the product is "for latex-sensitive condom users," and on the back of the box must tell a potential buyer that risks for pregnancy and STDs are not known for the product. Upon reading this disclaimer, the consumer then reads that "latex condoms for men, if used correctly with every act of vaginal intercourse, are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection)."

Condoms↗
PubMed1996

Spermicide effects questioned by FDA panel.

Spermicides clearly work better than no contraceptive at all, but there's no way to say how effective they are or whether women should opt for a gel, foam, suppository, or film, a scientific panel concluded. The advisors to the US Food and Drug Administration (FDA) heard disturbing evidence that women who rely on spermicides as their sole contraceptive have anywhere from a 9% to a 57% chance of becoming pregnant within a year. Spermicides appear to work best when used just 30 minutes before intercourse, said Dr. James Trussell of Princeton University. Nobody knows for sure how well spermicides work, and which work best, because the only studies ever performed were flawed. The manufacturers never proved how well their products work because they hit the market in 1950, before the FDA required such proof. The US National Institutes of Health (NIH) plans to begin a study comparing one brand of each type of commercially available spermicide to see how effective they are. The results will not be available for at least 4 years, so the FDA is debating what to tell consumers in the meantime and if that study will be enough. The FDA may soon change spermicide labels at least to rank the products as less effective than other contraceptives, Dr. Lisa Rarick, FDA reproductive health chief, said. Spermicides also should bear a warning that they may cause vaginal irritation, a condition one study suggests might increase a woman's chances of catching HIV, the scientific panel told the FDA. The same panel agreed, however, that spermicides can help protect women against two other sexually transmitted diseases, gonorrhea and chlamydia.

Americas↗
PubMed1996

Advantage 24 nonoxynol-9 product discussed at meeting. Contraception (spermicides).

Columbia Laboratories, Inc., Miami, Florida, reported safety data on the spermicidal product Advantage 24 that show it is safe even when administered four times a day, according to data from the UN Global Program on HIV/AIDS (UNAIDS) and the US National Institutes of Health (NIH). The data were reported at a meeting of the Nonprescription Drugs, Reproductive Health Drugs, Anti-Infective Drugs, and Antiviral Drugs advisory committees of the US Food and Drug Administration. Because of its favorable safety profile, Advantage 24 was the only product that UNAIDS selected for testing to determine its effectiveness against the spread of sexually transmitted diseases (STDs). Therefore, in May 1996, Columbia Laboratories and UNAIDS announced the initiation of an international Phase III clinical study of Advantage 24 for the prevention of the heterosexual transmission of HIV and STDs in approximately 2000 women. Additionally, the NIH is performing similar testing in Africa. Advantage 24, which uses Columbia Laboratories' patented bioadhesive delivery system to deliver nonoxynol-9, currently is marketed in the US by Lake Pharmaceuticals, Inc., and in Canada by Roberts Pharmaceuticals, as a long-lasting, vaginally delivered spermicide, pursuant to strategic alliance agreements with Columbia Laboratories.

Americas↗