24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
Fax: (361)578-5500
Regular Hours: M-Fri 8am - 5pm
Every 3rd Thurs of the Month - Extended Hours Until 7 pm

Medical Disorders
Resources
Basic InformationLookupsLatest News
COVID Vaccine Won't Affect Fertility, But Getting COVID MightThree New Studies Confirm Power of Booster Shots Against OmicronHit Your Head? Look for These Warning Signs of ConcussionArthritis & the COVID Vaccine: What You Need to KnowCOVID Boosters Keep Older Americans Out of Hospitals: CDCCOVID Rapid Test Makers Struggling to Meet DemandAHA News: A Healthy Thyroid Can Be Key to a Healthy HeartAnother Study Finds Vaccine Booster 'Neutralizes' Omicron'Artificial Pancreas' Can Help Kids With Type 1 DiabetesGetting Back to Sports After Recovering from COVID-19Side Effects From New Cancer Meds Have Silver LiningDengue Virus Makes Mosquitoes Bite More OftenNew Clues to Why Some Develop 'Brain Fog' After COVIDVaccination Plus Prior Infection Best Defense Against COVIDBinge-Watching Could Raise Your Blood Clot RiskIs a Night in the Hospital Necessary After Hip, Knee Replacement?Crowded Emergency Rooms Cost Lives: StudyCOVID Restrictions Eased in EnglandNo Side Effects From Your COVID Vaccine? Don't Worry, It's Still WorkingNearly Half of Americans Gained Weight in Pandemic's First YearNo Evidence Breastfeeding Can Transmit CoronavirusWHO Says Worst of Pandemic Could Ease This Year if Vaccine Inequities ErasedBiden Plans to Send 400 Million N95 Masks to Americans for FreeHeart Function Rebounds for Kids With COVID-Linked MIS-CAHA News: What Heart and Stroke Patients Need to Know About COVID-19 in 2022Which Kids Are Most Vulnerable to Severe COVID-19?Vaping Might Worsen COVID-19 SymptomsToo Soon to Tell if Omicron Will End Pandemic: FauciWhite House Launches Website for Free Home COVID Tests One Day Ahead of SchedulePolitics Clouds Folks' Views on COVID Rules, Global Survey ConfirmsCOVID-19 Treatments: What You Need to KnowAt-Home COVID Tests Accurate for Ki​ds: StudyHere's How to Get Your Free Home COVID Test KitsInsurance Often Covers Ivermectin for COVID, Even Though Drug Doesn't WorkCOVID Cases Surge Again in U.S. Nursing HomesCBD and Cannabis Products for Acne, Psoriasis? Buyer Beware, Dermatologists SayCarbon Monoxide Deaths Soar During Power OutagesAHA News: Transplanting Pig Hearts Into Humans Offers Promise – and PerilCOVAX Program Has Now Sent 1 Billion COVID Vaccines to Poorer NationsCOVID Fatigue: Are You Among the 'Vaxxed & Done'?CDC Advises N95s as Best Masks Against CoronavirusYou Don't Have to Be a Smoker to Get Lung CancerSkipping COVID Vaccine in Pregnancy Brings Big Risks to Mothers, BabiesMasks Cut Distance Coronavirus Travels in Half, Study Finds1 in 10 People With COVID Still Infectious After 10 Days: StudyWorried About Omicron? Expert Offers Tips on Going Out SafelySupreme Court Blocks Biden's Vaccine Mandate for Large EmployersCould the 'Mono' Virus Help Trigger Multiple Sclerosis?AHA News: Obesity Harms Brain Health Throughout Life – Yet Scientists Don't Know WhyWhite House May Soon Offer 'High-Quality' Masks to Americans
Questions and AnswersLinks
Related Topics

Diabetes

Merck's COVID Pill Appears Effective, But May Pose Pregnancy Risks: FDA

HealthDay News
by Robert Preidt and Robin Foster
Updated: Nov 29th 2021

new article illustration

MONDAY, Nov. 29, 2021 (HealthDay News) -- Merck's experimental COVID-19 antiviral pill appears effective, but may pose risks for pregnant women, including birth defects and toxicity to developing fetuses, according to the U.S. Food and Drug Administration.

On Friday morning Merck announced updated results from its molnupiravir study that showed a smaller benefit than first thought: Among more than 1,400 adults in a company study, the drug reduced the combined risk of hospitalization and death by 30 percent, less than the 50 percent first reported.

Nearly 7 percent of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died. That compared to 10 percent of patients hospitalized who were taking a placebo and nine deaths.

Potential risks were also identified in animal studies of molnupiravir, according to an analysis by FDA scientists. The agency's report was posted in advance of a meeting Tuesday of the FDA's outside experts who will weigh emergency use of the pill.

Based on its findings, the FDA will ask its expert panel whether the pill should never be given during pregnancy or if it could be used in certain situations where the benefits outweigh the risks. Given the safety concerns, FDA scientists said Merck agreed the drug would not be used in children.

The agency isn't required to follow the advice of its advisory panels, but it typically does.

Data from a small human clinical trial assessing the pill showed "no major safety concerns," according to the FDA review. About 2% of patients experienced diarrhea.

If authorized, the pills would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K.

Molnupiravir works by inserting tiny mutations into the coronavirus’ genetic code to stop the virus from reproducing.

The FDA scientists did note that the drug causes small changes in the spike protein used by the coronavirus to penetrate human cells, and theoretically those changes could lead to dangerous new variants, the AP reported.

More information

Visit the U.S. Food and Drug Administration for more on COVID treatments.


SOURCE: Associated Press