The Society for Menstrual Cycle Research holds that this use of COCPs does not have sufficient safety studies to justify promotion as a lifestyle choice (as opposed to medical indications), and criticizes what it perceives as negative portrayals of normal menstrual cycles in promotional literature for extended and continuous COCP use.Womens satisfaction with their contraception, compliance in taking the pills on time, and discontinuation rates are not significantly different between traditional and extended cycle regimens. Side effects
With all extended-cycle COCPs, breakthrough bleeding is the most common side effect, although it tends to decrease over time. In a 12-month study of a continuous COCP regimen, 59% of women experienced no bleeding in months six through twelve and 79% of women experienced no bleeding in month twelve. Extended or continuous use of COCPs or other combined hormonal contraceptives carries the same risk of side effects and medical risks as traditional COCP use. Ad campaign
One of the early extended-cycle COCPs, Seasonale, was marketed with the campaign, "Fewer periods. More possibilities." In December 2004, Barr Pharmaceuticals was warned by the FDA concerning these television advertisements. As the warning stated, "By omitting and minimizing the risks associated with Seasonale, the TV ad misleadingly suggests that Seasonale is safer than has been demonstrated by substantial evidence or substantial clinical experience." Although clinical studies had proven Seasonale to be effective in preventing pregnancy, the FDA felt the commercial advertisements omitted the common side effects of irregular vaginal bleeding or spotting.
Pharmacokinetics
As with all potent bisphosphonates, the fraction of the drug that reaches the circulatory system intact (systemic bioavailability) after oral dosing is low, averaging only 0.6–0.7% in women and in men under fasting conditions. Intake together with meals and beverages other than water further reduces the bioavailability. The absorbed drug rapidly partitions, with approximately 50% binding to the exposed bone surface; the remainder is excreted unchanged by the kidneys. Unlike with most drugs, the strong negative charge on the two phosphonate moieties limits oral bioavailability, and, in turn, the exposure to tissues other than bone is very low. After absorption in the bone, alendronate has an estimated terminal elimination half-life of 10 years. References
External links
"Alendronic acid". Drug Information Portal. U.S. National Library of Medicine. "Alendronate sodium". Drug Information Portal. U.S. National Library of Medicine.