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Does Plan B Have Gluten in It? Ingredients and Allergen Information

4 min read

According to product information available from the FDA, the emergency contraceptive Plan B One-Step does not contain any intentionally added gluten, wheat flour, or gluten-containing grains. This information is crucial for individuals with celiac disease or gluten sensitivities who need to take this medication without triggering an adverse reaction.

Quick Summary

Plan B One-Step does not contain gluten ingredients, using starches derived from corn and potato instead, making it safe for individuals with celiac or sensitivities, though it is not officially certified gluten-free.

Key Points

  • No Gluten Ingredients: The active ingredient, levonorgestrel, and inactive ingredients like corn and potato starches do not contain gluten.

  • Not Certified: While it does not contain gluten ingredients, Plan B is not certified gluten-free, which could be a concern for those with severe celiac disease.

  • Contains Lactose: The pill includes lactose monohydrate, a form of milk sugar, which is relevant for individuals with lactose intolerance.

  • Safe for Most: For the majority of people with gluten sensitivity, the risk of a reaction from Plan B is extremely low, as it contains no wheat starch.

  • Consult a Professional: If you have severe celiac disease or specific dietary concerns, speaking with a healthcare provider or pharmacist is the safest course of action.

  • Check Generics: Ingredients in generic levonorgestrel tablets can vary, so always check the specific product label to be sure.

In This Article

Understanding the Ingredients of Plan B

Plan B One-Step is an emergency contraceptive containing a single active ingredient: levonorgestrel. The active ingredient is a synthetic hormone that has been used in many birth control pills for decades. The pill works by temporarily delaying ovulation, or the release of an egg from the ovary, to prevent fertilization. In addition to the active ingredient, medications are formulated with inactive ingredients, or excipients, which help to bind the tablet together, protect it from moisture, and provide bulk.

For Plan B One-Step, the official product label from the FDA lists the inactive ingredients as colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc. Notably, the label specifies the use of corn and potato starches, not wheat starch. This is the key piece of information for anyone concerned about gluten content, as gluten is a protein found in wheat, barley, and rye. The manufacturer, Teva, also confirms that Plan B One-Step does not contain gluten, or any ingredients derived from gluten-containing grains.

The Difference Between 'Gluten-Free' and 'Certified Gluten-Free'

It is important to understand the distinction between a product that is 'gluten-free' and one that is 'certified gluten-free'. A product is considered gluten-free if it does not contain gluten ingredients. The FDA, for instance, has stated they are unaware of any oral drug products in the US with intentionally added wheat gluten. However, the issue lies in potential cross-contamination during the manufacturing process. A product labeled 'certified gluten-free' has undergone third-party testing to ensure it meets strict standards for gluten content, often less than 20 parts per million (ppm).

Manufacturers of generic levonorgestrel tablets, including those referencing Plan B One-Step, often state that their product does not contain gluten or ingredients derived from gluten-containing grains but is not certified gluten-free. For most people with gluten sensitivity, this is more than sufficient. For individuals with severe celiac disease or those who are extremely sensitive, the lack of certification might be a point of caution. It is always recommended to consult with a doctor or pharmacist to discuss your specific concerns.

Potential Cross-Contamination and Other Allergens

While the risk of gluten cross-contamination in Plan B is low, it is not zero. As mentioned, the product is not certified gluten-free, which means there could be a trace amount present, though this is likely to be far below the threshold that would cause a reaction in most individuals. The Celiac Disease Foundation notes that if wheat happens to be an impurity, the amount of gluten is typically well below the safe limit for most celiac patients.

Beyond gluten, individuals should be aware of other potential allergens. One of the inactive ingredients in Plan B One-Step is lactose monohydrate, a form of milk sugar. People with lactose intolerance or a milk allergy may experience stomach upset or other symptoms after taking the pill. The product's packaging and informational inserts will list all inactive ingredients, and it is crucial to read them carefully if you have any allergies or intolerances.

How Plan B Compares to Other Emergency Contraceptives

When considering emergency contraception, especially with dietary restrictions, it is helpful to look at all available options. Below is a comparison table outlining the gluten status of several types of emergency contraception.

Contraceptive Type Active Ingredient Gluten Status (General) Notes on Allergens
Plan B One-Step Levonorgestrel Gluten-Free (Not Certified) Contains lactose monohydrate.
Ella (ulipristal acetate) Ulipristal Acetate Call Manufacturer Prescription needed. Ingredients must be checked with the manufacturer due to potential variation.
Generic Levonorgestrel Levonorgestrel Varies (often gluten-free) Inactive ingredients can differ; always check the specific product label. Most generics state they do not contain gluten.
Copper IUD Copper Gluten-Free This is a non-hormonal, non-oral device, and therefore does not contain any gluten. It is the most effective form of emergency contraception.

Important Considerations for Individuals with Celiac Disease

For individuals with celiac disease, taking medication can be a source of anxiety. Here are some key steps to ensure your safety:

  • Read the Label: Always read the list of inactive ingredients on the product packaging. Do not assume that Plan B or any generic version is automatically safe.
  • Verify with the Manufacturer: If you have severe celiac disease or are highly sensitive, call the manufacturer's customer service line. They can provide the most current and specific information regarding their manufacturing process and allergen controls.
  • Inform Your Healthcare Provider: If you have to take emergency contraception, mention your celiac diagnosis or gluten sensitivity to the pharmacist or your doctor. They can help you make the best choice, such as recommending a brand with confirmed gluten-free status or suggesting an alternative method like the copper IUD.

The Final Word

The ingredients in Plan B One-Step have been confirmed to not contain gluten or gluten-containing grains. While the product is not officially certified gluten-free, it is considered safe for most individuals with celiac disease or gluten sensitivity. However, those with severe sensitivities should exercise caution and always verify ingredient information directly with the manufacturer. The presence of lactose monohydrate is another important consideration for individuals with milk-related intolerances. For the most up-to-date and specific details, refer to the manufacturer's website or the FDA's drug database. Accessdata.fda.gov.

Conclusion

Plan B One-Step, the emergency contraceptive, is formulated without gluten-containing ingredients, relying on corn and potato starches instead. This makes it a generally safe option for individuals with celiac disease or gluten sensitivity, although it is not officially certified as gluten-free due to the potential for trace cross-contamination. Users with severe sensitivities should consider calling the manufacturer for confirmation. Furthermore, those with lactose intolerance should be aware of the presence of lactose monohydrate in the tablet. As with any medication, carefully reading the label and consulting with a healthcare provider is the best approach to managing dietary and health concerns.

Frequently Asked Questions

Yes, levonorgestrel is a synthetic hormone and is inherently gluten-free. The gluten concerns are typically related to the inactive ingredients, such as starches and binders, which are derived from corn and potatoes in Plan B.

Many generic versions of levonorgestrel, such as those from Xiromed, also state that they do not contain gluten or gluten-containing grain derivatives. However, inactive ingredients can vary between manufacturers, so it is always important to check the product label of any generic brand you are considering.

The risk of cross-contamination is low, as the manufacturer states no gluten ingredients are used. However, since the product is not officially certified gluten-free, trace amounts could potentially exist. This is unlikely to affect most individuals but is a consideration for those with severe celiac disease.

Yes, Plan B One-Step contains lactose monohydrate as an inactive ingredient. This means individuals with lactose intolerance or a milk allergy may want to exercise caution or consult a doctor. The product does not contain soy.

For most individuals with celiac disease, Plan B is considered safe as it contains no intentionally added gluten. For those with extremely high sensitivity, consulting a doctor and considering alternative, certified-free methods or non-oral options like a copper IUD may be prudent.

The official list of ingredients, both active and inactive, can be found on the product's package insert, the manufacturer's website, or in the drug label database on the FDA website.

The most effective and completely gluten-free emergency contraceptive is the copper intrauterine device (IUD), as it is a non-oral device. Other emergency contraceptive pills, like Ella, require a check with the manufacturer regarding their specific inactive ingredients.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.