Medical Disorders
Resources
Basic InformationLookupsLatest News
Listeria Outbreak Linked to Deli Meats, Cheeses in 4 StatesWill You Get Fat? Genetic Test May TellFood Allergies Can Strike at Any AgeWhy a Knee Replacement Can Go BadExperimental Blood Thinner May Help Prevent Stroke, Without the Bleeding RiskBuyer Beware When Purchasing Medical Test StripsEgg Allergy? Don't Let That Stop You From Getting VaccinatedGene Therapy Might Prove a Cure for 'Bubble Boy' DiseaseTwo Lives Saved in Rare 'Paired' Liver DonationHealth Tip: Stopping NosebleedsKids Can Get UTIs, TooWhy More Patients Are Surviving an AneurysmCommon Diabetes Drug May Also Shield Kidneys, Heart'Added Sugars' Label on Foods Could Save Many LivesCPAP Brings Longer Life for Obese People With Sleep Apnea: StudyYoung Athletes Need to Be Sidelined After Bout of MonoPre-Cut Melons at Kroger, Walmart, Other Stores May Carry SalmonellaCDC Says Ground Beef Is Source of E. coli Outbreak, Cases Rise to 109AHA News: Is Yoga Heart-Healthy? It's No Stretch to See Benefits, Science SuggestsFDA Orders Label Warning on Alcohol Use With 'Female Viagra'Could Treating Gut Bacteria Help Ease Autism Symptoms?Hospital Privacy Curtains Could Be Breeding Ground for GermsItchy Skin Common Alongside Kidney DiseaseMany Misdiagnosed With MSVehicle Exhaust Drives Millions of New Asthma Cases AnnuallyNFL Retirees Help Scientists Develop Early Test for Brain Condition CTEMigraine Pain Linked to Raised Suicide RiskMore Time Spent in Sports, Faster Healing From ConcussionHealth Tip: Thermometer OptionsStill No Source as E. Coli Outbreak Grows to 96 Cases Across 5 States: CDCClimate Change Could Worsen Sneezin' SeasonEvenity Approved for Osteoporotic WomenNYC Declares Public Health Emergency Over Brooklyn Measles OutbreakInsurers' Denials of Opioid Coverage Spurs CDC to Clarify GuidelinesImmune-Targeted Treatment Might Help Prevent Peanut Allergy CrisesCluster of Dangerous Antibiotic-Resistant E. Coli Infection Spotted in NYCHealth Tip: Managing Chronic MigrainesFor One Man, Too Much Vitamin D Was DisastrousCDC Investigates Mystery E. Coli Outbreak Affecting 5 StatesBlacks Live Longer, Not Necessarily Better, With ALSIs It Heartburn or Something Else?Lungs, Hearts Infected With Hepatitis C Still OK for TransplantUnhealthy Diets May Be World's Biggest KillerSevere 'Mono' Infection May Raise Risk for Chronic Fatigue SyndromeUnder-the-Tongue Allergy Pills Replacing Shots for ManyFish Slime Could Hold Key to Beating 'Superbug' InfectionsPet Hedgehogs Still Spreading Salmonella, CDC WarnsCimzia Approved for Inflammatory ArthritisSpring Is the Sneezing SeasonU.S. Flu Season Ebbing, but Cases Still Widespread: CDC
Questions and AnswersVideosLinksBook Reviews
Related Topics

Cancer
Men's Health
Women's Health

FDA Orders Label Warning on Alcohol Use With 'Female Viagra'

HealthDay News
by -- Robert Preidt
Updated: Apr 12th 2019

new article illustration

FRIDAY, April 12, 2019 (HealthDay News) -- A drug touted as a "female Viagra" can cause severe low blood pressure and fainting when used with alcohol, the U.S. Food and Drug Administration warns.

As a result, the agency has ordered the drug's maker Sprout Pharmaceuticals to make a safety labeling change to Addyi (flibanserin).

The boxed warning, contraindication, warnings and precautions, and adverse reactions sections of the drug's labeling will advise women to stop drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. The drug is prescribed to be taken once daily, generally at bedtime.

Women should not drink alcohol until at least the morning after a dose of Addyi, the FDA said.

The FDA approved the drug in August 2015 to treat low sexual desire in older women. The order for the labeling change followed a review of postmarketing studies of Addyi.

An FDA statement said the agency ordered the labeling change as Sprout continued to push for removing the boxed warning and contraindication about alcohol. "Based on a careful review of available data … removing this important safety information was not acceptable for the protection of public health," the FDA statement said.

Sprout conducted one of the postmarketing studies as a condition of Addyi's FDA approval. Though there were no reports of severe low blood pressure or fainting requiring treatment among participants, safety precautions built into the study did not allow adequate assessment of this risk, according to the FDA.

During the study, women who had low blood pressure while lying down or related symptoms such as dizziness weren't allowed to stand up for blood pressure readings. Or, they were required to have repeated readings while lying down until their results were high enough so they could safely stand.

As a result, study data had missing or delayed measurements from these women, FDA said.

There were many more missing or delayed blood pressure readings when women took Addyi and alcohol together than when they took either alone. The greatest number of missing readings occurred near the time when the drug's blood levels were highest in women taking Addyi with alcohol, according to the FDA.

This pattern of missing or delayed blood pressure readings "provides further evidence of an interaction between Addyi and alcohol that can increase the risk of" low blood pressure and fainting, the FDA said.

Other postmarketing studies found that the risk of severe low blood pressure and fainting was lower when women who had at least two alcoholic drinks waited at least two hours before taking Addyi.

Sprout has until April 16 to appeal the order.

More information

The Mayo Clinic has more on low sex drive in women.




Facebook

Amazon Smile

To quit smoking, call Connecticut QuitLine at 1-800-QUIT-NOW.

Children and Adult services are available now with no wait time.  Please contact HBH Intake Department at 860-548-0101, option 2.

 


powered by centersite dot net