The monophasic Sprintec is not discontinued
For patients who have been taking the combined oral contraceptive Sprintec, rest assured that the medication is not discontinued and is still on the market. This generic birth control pill is manufactured by Teva Pharmaceuticals and is an FDA-approved equivalent of the brand-name Ortho-Cyclen, which has been discontinued. However, patients became concerned about availability due to recent issues with a related product, which led to a widespread misunderstanding.
The difference between Sprintec, Tri-Sprintec, and Tri-Lo-Sprintec
The confusion surrounding Sprintec's status can be clarified by understanding the differences between the various products carrying the "Sprintec" name. All contain the same active ingredients—norgestimate (a progestin) and ethinyl estradiol (an estrogen)—but differ in their hormone dosage and cycle type.
- Sprintec (monophasic): This is a monophasic pill, meaning every active tablet in the 28-day pack contains the same dose of hormones (0.25 mg norgestimate and 35 mcg ethinyl estradiol).
- Tri-Sprintec (triphasic): This is a triphasic pill, which means the active tablets contain three different dosages of hormones at three different phases of the cycle to better mimic the body's natural hormone fluctuations. It also contains 35 mcg of ethinyl estradiol.
- Tri-Lo-Sprintec (low-dose, triphasic): This triphasic pill contains a lower dose of estrogen (25 mcg ethinyl estradiol) compared to Tri-Sprintec.
Understanding the Tri-Lo-Sprintec recall of 2024
The source of the recent alarm was a voluntary recall of specific lots of Tri-Lo-Sprintec initiated by Teva in March 2024.
The reason for the recall
The recall was triggered after samples of the tablets failed to meet dissolution specifications during testing. This meant the medication might not dissolve properly in the body, potentially leading to a decrease in its efficacy and increasing the risk of an unplanned pregnancy.
FDA classification
Because the recall was prompted by a potential risk of therapeutic failure, the FDA classified it as a Class II recall. This classification means the product "might cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm". Importantly, it was not an urgent, Class I recall, which would have indicated a more serious health threat.
Prior shortages and patient confusion
In late 2023, patients reported temporary unavailability of Tri-Lo-Sprintec. In online forums, some claimed to have received confirmation from Teva that these shortages were due to manufacturing and supply chain issues related to the acquisition of necessary ingredients. This prior uncertainty, coupled with the official recall in 2024, amplified patient concern and fueled the belief that all Sprintec-branded products were being discontinued.
Finding safe alternatives to Sprintec and its relatives
For those who were prescribed the recalled Tri-Lo-Sprintec, or for patients simply seeking alternatives, several generic equivalents containing norgestimate and ethinyl estradiol are available. These products must meet the same FDA standards for safety and efficacy as the original brand-name medication.
Some alternatives to consider include:
- Monophasic options (equivalent to Sprintec): Estarylla, Previfem, Mili, Mono-Linyah, Femynor
- Low-dose, triphasic options (equivalent to Tri-Lo-Sprintec): Tri-Lo-Estarylla, Tri-Lo-Mili, Tri-Vylibra Lo
Sprintec and related generics comparison
| Pill Type | Example Brands | Active Ingredients | Phase | Estrogen Dose |
|---|---|---|---|---|
| Sprintec | Sprintec, Estarylla, Mili, Previfem | Norgestimate, Ethinyl Estradiol | Monophasic | 35 mcg |
| Tri-Sprintec | Tri-Sprintec, Tri-Estarylla, Tri-Linyah | Norgestimate, Ethinyl Estradiol | Triphasic | 35 mcg |
| Tri-Lo-Sprintec | Tri-Lo-Sprintec, Tri-Lo-Estarylla, Tri-Lo-Mili | Norgestimate, Ethinyl Estradiol | Triphasic | 25 mcg |
How to safely switch birth control pills
If you need to switch from Tri-Lo-Sprintec to another contraceptive, follow these guidelines to ensure continued protection:
- Consult your doctor: This is the most important step. Your healthcare provider can recommend the best alternative based on your health history and will provide clear instructions for making the switch.
- Switch immediately: You can typically start your new pill pack the day after taking the last active pill from your old pack. For most combination pills, this ensures continuous protection without a gap.
- Finish the current pack: The simplest way to switch is to finish your current pack, including placebo pills, then start the new brand the next day. This keeps your cycle on track and prevents wasting medication.
- Use backup contraception if needed: If you miss any pills during the switch or are unsure of your protection, use a backup method like condoms for at least the first seven days.
Conclusion: No need for panic
While the recent recalls and shortages of Tri-Lo-Sprintec caused understandable confusion and anxiety for patients, it is crucial to recognize that the monophasic oral contraceptive Sprintec was not discontinued and remains an available option. The incident highlights the importance of distinguishing between different medication formulations, even when they share a similar name. Always consult with a pharmacist or healthcare provider if you have questions about a recall or need assistance finding a suitable alternative. They can provide the most accurate and up-to-date information regarding your medication's status and ensure you maintain effective contraceptive protection.
For more official information on drug recalls, consult the U.S. Food and Drug Administration (FDA) website, which provides information on recalls and safety alerts.
