Taking Pills For Hot Flashes? FDA Issues Strongest Warning On A Menopausal Drug Linked To Serious Liver Injury

If you are treating hot flashes or other menopausal symptoms, it’s time to take a closer look at your medication. The FDA has issued its strongest safety alert, a boxed warning, on a menopausal drug linked to severe liver injury.

“The U.S. Food and Drug Administration (FDA) is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal,” the FDA said in a news release.

Veozah is an FDA-approved treatment for moderate to severe vasomotor symptoms, the medical term for a group of menopausal symptoms including night sweats and hot flashes.

The drug is a nonhormonal prescription medicine that belongs to the neurokinin 3 (NK3) receptor antagonist class. It helps balance estrogen and neurokinin B (NKB) by blocking NK3 receptors, which affect body temperature control. Common expected side effects include stomach pain, diarrhea, difficulty sleeping, back pain, and hot flashes.

The prescribing information of Veozah already included warnings about elevated liver blood test values and the need for liver monitoring. The FDA has now updated its recommendations for testing and strengthened its warning after reviewing a postmarketing case where a patient developed elevated liver blood test values and signs of liver injury after about 40 days of use.

The patient’s symptoms, including fatigue, nausea, itching, yellowing of the eyes and skin, light-colored stools, and dark urine, gradually improved, and blood test values returned to normal after stopping the medication.

According to the updated recommendation, patients and healthcare professionals are now advised to conduct monthly liver tests for the first two months, along with the existing tests at months 3, 6, and 9.

“The updated prescribing information also instructs patients to stop the medicine immediately and contact the health care professional who prescribed the medicine if signs and symptoms of liver injury occur,” the news release stated.

Since individual responses to medications vary based on factors like health, genetics, underlying conditions, and other medications, the FDA stated that it is impossible to predict how likely someone is to develop these liver issues.

Meanwhile, Astellas, the drug’s manufacturer, stated that the “overall benefit-risk of Veozah remains positive” but stressed the importance of ensuring patients and healthcare providers are aware of the potential side effects.