The European brand Qlaira vs. the US brand Natazia
Bayer, the pharmaceutical manufacturer, markets this specific birth control formulation under different brand names in different regions of the world. In Europe and other countries, the product is known as Qlaira. However, in the United States, the Food and Drug Administration (FDA) approved and licensed the pill under the brand name Natazia in 2010. This distinction is why you will not find Qlaira on US pharmacy shelves, even though the same active ingredients are available with a prescription for Natazia.
How Natazia (Qlaira) works
Natazia is a combined oral contraceptive (COC) that uses a unique quadriphasic dosing regimen. This means the amount of hormones changes four times throughout the 2 8-day cycle. The hormones involved are estradiol valerate (a prodrug that is metabolized into natural estradiol) and dienogest (a synthetic progestin). This dynamic dosing schedule is designed to mimic the body's natural hormonal cycle more closely than traditional COCs, while still providing reliable contraception.
The primary mechanism of action for Natazia involves several steps:
- Suppression of ovulation: The hormones prevent the release of an egg from the ovaries.
- Thickening of cervical mucus: This makes it more difficult for sperm to pass through the cervix and reach an egg.
- Thinning of the uterine lining: This makes the uterine environment less receptive to implantation should fertilization occur.
Indications and benefits
In the US, Natazia (the equivalent of Qlaira) is FDA-approved for two main indications:
- Pregnancy prevention: It is an effective method of birth control when taken as directed.
- Treatment of heavy menstrual bleeding: Natazia has been shown to reduce excessive menstrual blood loss in women who do not have uterine-related conditions and who also want to use an oral contraceptive. This makes it a dual-purpose medication that can address two common concerns for women of reproductive age.
The quadriphasic dosing regimen
The 28-day pill pack of Natazia features pills of different colors, each containing a specific combination or amount of hormones. This specific progression of hormone levels is designed to provide good cycle control and minimize unscheduled bleeding. The shorter hormone-free interval (two inactive pills) at the end of the cycle is another feature distinguishing it from traditional COCs.
Common side effects and risks
Like all combined hormonal contraceptives, Natazia comes with potential side effects and risks. It is important to discuss these with a healthcare provider before starting the medication.
Common side effects may include:
- Headaches
- Nausea
- Breast tenderness
- Irregular bleeding or spotting, particularly during the first few months
- Changes in mood
- Weight changes
More serious, though less common, risks include:
- Blood clots: All combined hormonal contraceptives carry an increased risk of venous and arterial thromboembolism. This risk is higher in individuals with certain risk factors, such as smoking, obesity, or a history of blood clots.
- Cardiovascular events: The risk of heart attack and stroke is increased, especially in women over 35 who smoke.
- Liver problems: Rare but serious liver issues can occur.
- Cancer: Use is associated with a slightly increased risk of breast and cervical cancer, which diminishes after stopping the pill.
Natazia (US equivalent of Qlaira) vs. Standard Combined Oral Contraceptives
Feature | Natazia (Qlaira) | Standard COCs (e.g., those with ethinyl estradiol) |
---|---|---|
Estrogen | Estradiol valerate (metabolized to natural estradiol) | Ethinyl estradiol (synthetic estrogen) |
Dosing Regimen | Quadriphasic (4 different hormone levels) | Monophasic, biphasic, or triphasic |
Inactive Pills | 2-day hormone-free interval | Typically 7-day hormone-free interval |
Heavy Bleeding Indication | FDA-approved to treat heavy menstrual bleeding | Some formulations may be used off-label, but Natazia is specifically indicated |
Bleeding Profile | Can lead to shorter, lighter withdrawal bleeds and potentially fewer bleeding days overall, though a higher chance of absent withdrawal bleeding. | Varies by formulation; generally aims for predictable withdrawal bleeding. |
Conclusion
In summary, for someone in the US asking, "What is Qlaira in the US?", the direct answer is that Qlaira is not available under that brand name. The product is marketed as Natazia in the United States and contains the same active ingredients: estradiol valerate and dienogest. Natazia is a quadriphasic combined oral contraceptive used for both pregnancy prevention and the management of heavy menstrual bleeding. Its unique formulation and shorter hormone-free interval offer an alternative to traditional birth control pills containing synthetic ethinyl estradiol. As with any medication, users should discuss the benefits and risks with a healthcare provider to ensure it is a safe and appropriate choice for their individual needs. For more information on Natazia, resources from the manufacturer, Bayer, and the FDA are available online.
Resources
For additional information, you can review the FDA-approved labeling for Natazia: