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PATIENTS

What is the PROVIGIL Pregnancy Registry?

During the development of PROVIGIL, pregnant women were actively excluded from clinical trials. As a result, there are limited human data regarding the effects of PROVIGIL during pregnancy. For this reason, Teva Pharmaceuticals, the manufacturer of PROVIGIL, has established the PROVIGIL Pregnancy Registry to collect information about the pregnancy outcomes of women exposed to PROVIGIL around the time of conception and/or during pregnancy.

Why should I participate in the PROVIGIL Pregnancy Registry?

Your participation in the PROVIGIL Pregnancy Registry will provide important information that may be used by healthcare providers and future patients in weighing the benefits and risks associated with the use of PROVIGIL during pregnancy. PROVIGIL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The success of the PROVIGIL Pregnancy Registry depends on the continued participation of pregnant women like you and their healthcare providers for registration and follow-up both during pregnancy and after delivery.

For more information about pregnancy registries, visit
http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134844.htm.

Can I take part in the PROVIGIL Pregnancy Registry?

If you are pregnant and have taken at least one PROVIGIL tablet within 6 weeks of becoming pregnant or at any time during your pregnancy, you may be eligible to participate in the Registry.

Talk to your doctor about taking PROVIGIL if you are pregnant, nursing, or plan to become pregnant.

How can I enroll in the Registry, and what will I need to do if I participate?

To learn more about the PROVIGIL Pregnancy Registry and to find out if you qualify for enrollment, contact a Registry representative at 1-866-404-4106 (toll-free). You may also ask your healthcare provider to enroll you.

If you are eligible and would like to participate, you will be asked to read and sign an informed consent document. After the signed document is received, a Registry representative will contact your healthcare provider (obstetrician, primary care doctor, pediatrician, or other healthcare provider) to confirm your personal health information.

Your participation in the Registry may last throughout your pregnancy and up to 12 months after your delivery date. You may be asked to participate in up to 7 telephone interviews (on enrollment, at each trimester of pregnancy, within 2 months after your delivery, and when your baby reaches 6 months and 1 year of age). During these interviews, you will be asked to provide information about your health and your baby’s health. No clinic visits are required.

The information you provide, as well as your name and the names of any individuals you provide, will be held in strict confidence.

Because the success of the Registry depends on the ability of Registry staff to contact patients and their healthcare providers, it is important that you keep the Registry informed of any changes in your contact information throughout your participation.

What are my rights as a Registry participant?

Participation in the Registry is entirely voluntary, and you may withdraw at any time.

Protecting your privacy is important to the PROVIGIL Pregnancy Registry. If you decide to participate and are found to be eligible, you will be asked to read and sign an informed consent document that contains detailed information about the Registry, including how your personal information will be used. This document will also permit Registry staff to collect personal health information from all healthcare providers involved in your care and the care of your baby.

Whom can I contact for more information?

To speak to a Registry representative, contact the PROVIGIL Pregnancy Registry at
1-866-404-4106.

If you have questions about your treatment, contact your healthcare provider.

To learn more about PROVIGIL, visit www.PROVIGIL.com.