FDA Evaluating Potential Risk of Birth Defects with Dolutegravir
May 18, 2018 – Based on reports of neural tube birth defects, which involve the spine, spinal cord, and brain, the FDA will investigate possible risk factors associated with the use of dolutegravir to treat HIV in pregnant women.
The FDA’s decision comes as a result of an observational study conducted in Botswana, where neural tube birth defects were observed in children whose mothers were taking dolutegravir at the time of conception or early in their first trimester. However, there have been no reported cases of these birth defects occurring in the children of women who take dolutegravir later in their pregnancies.
Dolutegravir was first approved by the FDA in 2013. It is indicated for use in combination with other antiretroviral medications to treat HIV in adults and children at least 12 years of age weighing no less than 40kg (88lbs). In the United States, it is sold under the brand name Tivicay®, from GlaxoSmithKline, as a single-ingredient product, and is a component of the brand name combination products Juluca® (dolutegravir and rilpivirine) and Triumeq (abacavir, dolutegravir, and lamivudine), both manufactured by ViiV Healthcare.
Patients currently taking a dolutegravir product are advised to speak to their doctor before stopping or changing medication. For patients who are pregnant, stopping the medication without a physician’s guidance may raise the baby’s risk of exposure to HIV in the womb. Because neural tube defects occur early in pregnancy, often before a woman is aware she is expecting, women with the potential to become pregnant should speak to their healthcare provider about an alternative to dolutegravir for HIV treatment, or consistently use effective birth control while on dolutegravir. Healthcare providers should also test for pregnancy before prescribing dolutegravir to women who have the potential to become pregnant.
Any adverse events that may be tied to dolutegravir should be reported to the FDA’s MedWatch program.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.