Health
FDA pushes unproven premature birth drug Makena off the market
WASHINGTON (AP) — On Thursday, the Food and Drug Administration ordered an immediate market withdrawal of a drug aimed at preventing premature births. Useless for pregnant women.
The decision follows repeated efforts by Swiss pharmaceutical company Covis Pharma to keep Makena in the U.S. market while it conducts additional research. This drug was the only drug approved in the United States to reduce the risk of premature birth in women who had a history of premature birth.
In recent months, Covis has finally bowed to FDA pressure. Suggest “Relaxation” A period of several months so that a woman on medication can complete her treatment. The FDA rejected that and said on Thursday that the action against Makena and some generic versions should take effect immediately.
“Makena and its generics are no longer approved and cannot be legally distributed in interstate commerce,” the agency said in a statement.
Injectable drugs are synthetic versions of progesterone, a hormone that helps the uterus maintain pregnancy. It can cause side effects such as blood clots, depression, and allergic reactions. Given these risks, FDA staff had previously concluded that there was no benefit to continuing to obtain the drug given the lack of confirmed benefits.
The final decision by FDA Commissioner Robert Calif and the FDA’s chief scientist marks the first time the FDA has formally forced the removal of a drug that was originally approved based on promising initial data. In one case, the drug company voluntarily stopped the drug after the FDA revealed its intent to order its removal.
The FDA accelerated approval of Makena in 2011. This was based on a small study suggesting that preterm birth rates were reduced in women who had previously had difficulty reaching term. However, the results of a study of 1,700 participants completed in late 2018 showed that the drug did not reduce premature births or provide healthy baby outcomes as was originally thought. I showed that
The FDA has since worked to remove the drug from the market, but Covis complained repeatedly More time to do further research.
In October, the company failed to convince a panel of outside FDA advisers that the drug should continue to be marketed for women at high risk of premature birth, including black women.
About 10% of U.S. births are too early — under 37 weeks, increasing the risk of serious health problems and infant death.
“It’s tragic that scientific research and the medical community have yet to discover treatments that have been shown to be effective in preventing premature birth and improving neonatal outcomes,” Caliph said Thursday. said in a statement. Ask the doctor, the agency said.
The FDA has faced pressure to crack down on unidentified drugs approved under its accelerated approval program, which has allowed dozens of drugs to launch based on early results since the early 1990s. I was.
The flip side of the program means eliminating drugs if their initial promise is not confirmed by subsequent research. Researchers and government oversight agencies have documented problems with FDA oversight. This includes delays in expedited removal of drugs with failed or missing validation studies.Over the past two years, FDA has made an effort Remove unproven approval, primarily from cancer treatments.
___
Follow Matthew Perrone on Twitter. @AP_FDA writer
___
The Associated Press’ Health Sciences Division is supported by the Scientific and Educational Media Group at the Howard Hughes Medical Institute. AP is solely responsible for all content.
Copyright 2023 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.
|
Sources 2/ https://www.ny1.com/nyc/all-boroughs/ap-top-news/2023/04/06/fda-forces-unproven-premature-birth-drug-makena-off-market The mention sources can contact us to remove/changing this article |
What Are The Main Benefits Of Comparing Car Insurance Quotes Online
LOS ANGELES, CA / ACCESSWIRE / June 24, 2020, / Compare-autoinsurance.Org has launched a new blog post that presents the main benefits of comparing multiple car insurance quotes. For more info and free online quotes, please visit https://compare-autoinsurance.Org/the-advantages-of-comparing-prices-with-car-insurance-quotes-online/ The modern society has numerous technological advantages. One important advantage is the speed at which information is sent and received. With the help of the internet, the shopping habits of many persons have drastically changed. The car insurance industry hasn't remained untouched by these changes. On the internet, drivers can compare insurance prices and find out which sellers have the best offers. View photos The advantages of comparing online car insurance quotes are the following: Online quotes can be obtained from anywhere and at any time. Unlike physical insurance agencies, websites don't have a specific schedule and they are available at any time. Drivers that have busy working schedules, can compare quotes from anywhere and at any time, even at midnight. Multiple choices. Almost all insurance providers, no matter if they are well-known brands or just local insurers, have an online presence. Online quotes will allow policyholders the chance to discover multiple insurance companies and check their prices. Drivers are no longer required to get quotes from just a few known insurance companies. Also, local and regional insurers can provide lower insurance rates for the same services. Accurate insurance estimates. Online quotes can only be accurate if the customers provide accurate and real info about their car models and driving history. Lying about past driving incidents can make the price estimates to be lower, but when dealing with an insurance company lying to them is useless. Usually, insurance companies will do research about a potential customer before granting him coverage. Online quotes can be sorted easily. Although drivers are recommended to not choose a policy just based on its price, drivers can easily sort quotes by insurance price. Using brokerage websites will allow drivers to get quotes from multiple insurers, thus making the comparison faster and easier. For additional info, money-saving tips, and free car insurance quotes, visit https://compare-autoinsurance.Org/ Compare-autoinsurance.Org is an online provider of life, home, health, and auto insurance quotes. This website is unique because it does not simply stick to one kind of insurance provider, but brings the clients the best deals from many different online insurance carriers. In this way, clients have access to offers from multiple carriers all in one place: this website. On this site, customers have access to quotes for insurance plans from various agencies, such as local or nationwide agencies, brand names insurance companies, etc. "Online quotes can easily help drivers obtain better car insurance deals. All they have to do is to complete an online form with accurate and real info, then compare prices", said Russell Rabichev, Marketing Director of Internet Marketing Company. CONTACT: Company Name: Internet Marketing CompanyPerson for contact Name: Gurgu CPhone Number: (818) 359-3898Email: [email protected]: https://compare-autoinsurance.Org/ SOURCE: Compare-autoinsurance.Org View source version on accesswire.Com:https://www.Accesswire.Com/595055/What-Are-The-Main-Benefits-Of-Comparing-Car-Insurance-Quotes-Online View photos
to request, modification Contact us at Here or [email protected]
 |
 |
 |
