FDA orders premature birth drug off market
WASHINGTON — The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women. The decision follows repeated efforts by Swiss drugmaker…#covispharma #makena #fda #robertcaliff (Source: Reuters: Health)
Source: Reuters: Health - April 6, 2023 Category: Consumer Health News Source Type: news
FDA forces unproven premature birth drug Makena off market
The Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market (Source: ABC News: Health)
Source: ABC News: Health - April 6, 2023 Category: Consumer Health News Tags: Health Source Type: news
FDA Forces Unproven Premature Birth Drug Makena Off the Market
WASHINGTON — The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women.
The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries.
In recent months, Covis finally bowed to FDA pressure, proposing a “winding down” pe...
Source: TIME: Health - April 6, 2023 Category: Consumer Health News Authors: Matthew Perrone/AP Tags: Uncategorized Drugs healthscienceclimate wire Source Type: news
Loud Incubators Might Damage Preemie Babies' Hearing
MONDAY, March 27, 2023 -- While an incubator can save the life of a premature baby, it may be contributing to hearing loss in these vulnerable infants.
A new study published March 27 in Frontiers in Pediatrics assessed the sounds in the neonatal... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 27, 2023 Category: General Medicine Source Type: news
Covid Worsened a Maternal Mortality Crisis in the U.S.
In 2021, deaths of pregnant women soared by 40 percent in the United States, according to new government figures. Here ’s how one family coped after the virus threatened a pregnant mother. (Source: NYT Health)
Source: NYT Health - March 17, 2023 Category: Consumer Health News Authors: Roni Caryn Rabin Tags: Coronavirus (2019-nCoV) Deaths (Fatalities) Pregnancy and Childbirth Maternal Mortality Premature Babies Birth Rates Vaccination and Immunization Disease Rates Indiana United States your-feed-science Source Type: news
Covid Worsened a Health Crisis Among Pregnant Women
In 2021, deaths of pregnant women soared by 40 percent in the United States, according to new government figures. Here ’s how one family coped after the virus threatened a pregnant mother. (Source: NYT Health)
Source: NYT Health - March 16, 2023 Category: Consumer Health News Authors: Roni Caryn Rabin Tags: your-feed-science Coronavirus (2019-nCoV) Deaths (Fatalities) Pregnancy and Childbirth Babies and Infants Birth Rates Maternal Mortality Women and Girls Premature Babies Vaccination and Immunization Coronavirus Risks and Safety Concern Source Type: news
The U.S. has a high rate of preterm births, and abortion bans could make that worse
The rates of premature birth in the U.S. are high, especially in certain states. Experts worry that states restricting abortion have fewer maternal care providers than those with abortion access.(Image credit: ER Productions Limited/Getty Images) (Source: NPR Health and Science)
Source: NPR Health and Science - March 15, 2023 Category: Consumer Health News Authors: Sarah Varney Source Type: news
March of Dimes raises funds, awareness for families
Candice Fajardo, executive director of March of Dimes Hawaii Market, promotes the organization's mission locally to prevent birth defects, premature births and infant mortality. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 9, 2023 Category: Pharmaceuticals Authors: Kelsey Kukaua Medeiros Source Type: news
Induced Labor Associated With Poor School Performance Induced Labor Associated With Poor School Performance
Although a study that found this association could not determine causality, it is possible that premature births could affect children ' s cerebral development.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 9, 2023 Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health News Source Type: news
Maker of unproven birth drug Makena to pull from US market
The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the United States (Source: ABC News: Health)
Source: ABC News: Health - March 8, 2023 Category: Consumer Health News Tags: Health Source Type: news
Only Drug to Prevent Premature Births Will Be Pulled from U.S. Market
The maker of the only drug approved to reduce the risk of premature labor in the U.S. wants to pull it off the market—gradually—years after research raised questions about how well it works.
Apollo Global Management’s Covis Pharma Group said it is trying to withdraw Makena in an orderly fashion after a U.S. Food and Drug Administration advisory panel recommended retracting its approval at a meeting in October. While the medicine had won accelerated approval in 2011, a subsequent study intended to confirm its benefits found it didn’t work better than older drugs.
An FDA division proposed pulling the ...
Source: TIME: Health - March 8, 2023 Category: Consumer Health News Authors: Michelle Fay Cortez/Bloomberg Tags: Uncategorized bloomberg wire Drugs healthscienceclimate Source Type: news
Preterm Birth Drug Withdrawn After 12 Years
The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women. (Source: NYT Health)
Source: NYT Health - March 8, 2023 Category: Consumer Health News Authors: Christina Jewett Tags: Recalls and Bans of Products Premature Babies Pregnancy and Childbirth Drugs (Pharmaceuticals) Babies and Infants Covis Pharma Group Food and Drug Administration Source Type: news
COVID Lockdowns Linked to Decline in Premature Births
THURSDAY, March 2, 2023 -- Premature births dropped during lockdowns in the early months of the COVID-19 pandemic.
A groundbreaking study, which included a group of mostly high-income countries — including the United States, Belgium, Canada,... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 2, 2023 Category: General Medicine Source Type: news
Premature Births Fell During Some Covid Lockdowns, Study Finds
Nearly 50,000 preterm births may have been averted across a group of mostly high-income countries in one month alone. (Source: NYT Health)
Source: NYT Health - March 2, 2023 Category: Consumer Health News Authors: Elizabeth Preston Tags: Premature Babies Coronavirus Risks and Safety Concerns Coronavirus (2019-nCoV) Pregnancy and Childbirth Nature Medicine (Journal) Research your-feed-science your-feed-healthcare Source Type: news
Wildfire Smoke May Send Pregnant Women Into Premature Labor
MONDAY, Feb. 13, 2023 -- Exposure to wildfire smoke can increase the risk of premature birth, new research suggests.
For the study, the researchers reviewed birth certificates and hospital delivery data for more than 2.5 million pregnant women in... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 13, 2023 Category: General Medicine Source Type: news
