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The Medical Letter on Drugs and Therapeutics • Jul 08, 2013 (Issue 1420)
The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.
The Medical Letter on Drugs and Therapeutics • Jun 24, 2013 (Issue 1419)
The progestin levonorgestrel is available over the counter for emergency contraception as two 0.75-mg tablets taken 12 hours apart (generic formulations of Plan B) and as a single 1.5-mg tablet taken once (Plan B One-Step, and generics). A third emergency contraceptive, ulipristal (Ella – Watson), is available with a prescription.1 It appears that, pursuant to a court order, Plan B One-Step (but not the generic products), which was previously available over the counter from a pharmacist only for women 17 years and older, will now be available directly from pharmacy shelves with no age...
The Medical Letter on Drugs and Therapeutics • Mar 18, 2013 (Issue 1412)
The FDA recently approved Skyla (Bayer), the first new intrauterine device (IUD) in the US in 12 years. It releases levonorgestrel, a synthetic progestin, over a period of 3 years. A table summarizing contraceptive methods available in the US appears on page 22.
The Medical Letter on Drugs and Therapeutics • Apr 30, 2012 (Issue 1389)
The FDA has announced that combination hormonal contraceptives (CHCs) containing the synthetic progestin drospirenone (Yaz, Yasmin, Beyaz, Safyral, and others) may be associated with a higher risk of thromboembolism than CHCs containing other progestins.1The new warning was based partly on an unpublished, FDA-funded, retrospective study that found a 1.7-times higher risk of venous thromboembolism among US women who used a CHC that contained drospirenone than among women whose CHC contained levonorgestrel, norgestimate or norethindrone as the progestin component.2 As with all retrospective...
The Medical Letter on Drugs and Therapeutics • Feb 06, 2012 (Issue 1383)
Nexplanon (Merck), a modified version of the contraceptive implant Implanon (Merck), is now available in the US. Nexplanon contains 68 mg of the progestin etonogestrel and is bioequivalent to Implanon. Both products are single-rod subdermal contraceptives implanted into the inside of the upper arm; both provide reversible effective contraception for up to 3 years.1 Nexplanon has a redesigned preloaded applicator intended to make insertion easier and reduce the risk of improperly placed devices. Proper placement is necessary to ensure adequate contraceptive efficacy and to facilitate future...
The Medical Letter on Drugs and Therapeutics • Jan 10, 2011 (Issue 1355)
The FDA has approved the use of ulipristal acetate (ella – Watson) as an emergency contraceptive that can be taken up to 5 days after unprotected intercourse. It is available only by prescription.
The Medical Letter on Drugs and Therapeutics • Dec 13, 2010 (Issue 1353)
Six years after an FDA advisory committee recommended development of a combination tablet containing an oral contraceptive and folic acid,1 the FDA has approved Beyaz (Bayer), a combination of the oral contraceptive Yaz2 with 451 mcg of levomefolate calcium, the primary metabolite of folic acid.3 According to the FDA, an unpublished double-blind, randomized U.S. trial in 379 healthy women 18-40 years old found that the combination increased serum folate levels. In an unpublished German study using a similar oral contraceptive/ levomefolate combination (summarized in the package insert),...
The Medical Letter on Drugs and Therapeutics • Mar 22, 2010 (Issue 1334)
Combination oral contraceptives increase the risk of venous thromboembolism (VTE). Their benefits, in addition to preventing pregnancy, include lowering the risk of ovarian and endometrial cancer, reducing dysfunctional uterine bleeding and increasing serum hemoglobin concentrations. Are these benefits worth the risk? And are some combination oral contraceptives safer than others?
The Medical Letter on Drugs and Therapeutics • May 18, 2009 (Issue 1312)
The FDA has announced that it will lower the age for over-the-counter access to the emergency contraceptive Plan B1 from 18 to 17 years old. In a randomized, controlled trial, the two 0.75-mg levonorgestrel tablets in Plan B, taken 12 hours apart beginning within 72 hours after unprotected intercourse, decreased the overall pregnancy rate to 1.1% (11/976) of women who requested emergency contraception.2 The sooner the drug is taken after coitus, the more effective it is. Nausea and vomiting can occur with Plan B. Fetal malformations have not been associated with pregnancies that occurred...
The Medical Letter on Drugs and Therapeutics • Jul 30, 2007 (Issue 1266)
Lybrel (Wyeth) is the first FDA-approved low-dose combination oral contraceptive taken 365 days a year without a placebo or pill-free interval. All tablets contain low doses of levonorgestrel (0.09 mg) and ethinyl estradiol (20 mcg). Most oral contraceptives are packaged as a 21/7 cycle (21 days of active tablets and 7 days of placebo), resulting in 13 withdrawal bleeding episodes each year. Two formulations are taken for 24 days followed by 4 days of inert tablets (Yaz and Loestrin 24). Two others (Seasonique and Seasonale) have a 91-day cycle with only 4 withdrawal bleeds per...