FDA Approves , Over-the-Counter , Overdose Medication.
On March 29, the United States Food
and Drug Administration (FDA) approved overdose
reversal drug Narcan for over-the-counter use.
ABC reports that the decision marks
a milestone that advocates say will
save lives amid the ongoing opioid crisis.
Narcan is made by
Emergent BioSolutions.
The drug is a nasal spray containing naloxone, which can restore breathing if someone is experiencing an opioid overdose.
.
According to medical experts, it is safe to administer
the drug to anyone who appears to be having an overdose,
even if it turns out they are not overdosing.
With the FDA's approval, the medication can now
be sold in places like drug stores, grocery stores,
convenience stores and even online.
With the FDA's approval, the medication can now
be sold in places like drug stores, grocery stores,
convenience stores and even online.
Today's approval of OTC naloxone nasal
spray will help improve access to naloxone,
increase the number of locations where
it's available and help reduce opioid
overdose deaths throughout the country, Dr. Robert M.
Califf, FDA Commissioner, via ABC.
We encourage the manufacturer to make
accessibility to the product a priority by
making it available as soon as possible
and at an affordable price, Dr. Robert M.
Califf, FDA Commissioner, via ABC.
According to the Centers for Disease Control
and Prevention, an estimated 107,622 drug
overdose deaths occurred in 2021, setting a record high.
ABC reports that a majority of those
deaths were the result of opioids, particularly
synthetic forms of opioids like fentanyl.
CDC and FDA Recommend , Updated COVID Boosters for , Everyone Over Six Months Old.
'The Independent' reports that updated COVID
boosters from both Pfizer and Moderna are now
available at pharmacies across the United States.
The Centers for Disease Control and Prevention
(CDC) and Food and Drug Administration (FDA)
both recommend one dose of an updated
vaccine for everyone over six months old.
Depending on their previous vaccination status,
both agencies say some children
may be eligible for up to three doses. .
'The Independent' reports that both
hospitalizations and deaths have
been on the rise in the U.S. for weeks.
At the same time, health authorities around the world
are monitoring the emergence of two new variants,
BA.2.86, known as Pirola, and EG.5, known as Eris.
According to data from the CDC, Eris is now
responsible for almost 25% of U.S. COVID
cases, after first being detected in February.
Meanwhile, Pirola has triggered a surge in cases
across a number of countries, including the U.S. .
The CDC warns that unvaccinated
individuals are more likely to get
severely ill if they are infected with COVID.
The National Institutes of Health (NIH) strongly
recommend that pregnant women get
the updated vaccine, citing a recent study.
The small study cited by the NIH found “protective
antibodies in nearly 75% of infants born to women
who had been vaccinated during pregnancy.”
Credit: Wibbitz Top Stories Duration: 01:31Published
DeSantis, Florida Surgeon General , Contradict Federal COVID Booster Guidance.
On Sept. 11, the FDA approved
a new COVID booster for
anyone 6 months of age and older.
The CDC recommended the
new shots on Sept. 12.
The vaccine is said to target Omicron subvariants that are spreading throughout the U.S.
But Florida Gov. Ron DeSantis and Surgeon General Joseph A. Ladapo are advising the state's residents to not get the booster shot if they're under age 65, 'The Washington Post' reports. .
The two men first made the comments during a live event last week and reiterated their claims during an X livestream on Sept. 13. .
I will not stand by and let the FDA and CDC use healthy Floridians as guinea pigs for new booster shots that have not been proven to be safe or effective. No way FDA, Gov. Ron DeSantis, via X livestream.
In December, DeSantis said he was forming a panel to counter the CDC's health recommendations, implying that the public has been misled about vaccine efficacy, 'The Washington Post' reports. .
In May, he barred vaccine passports and
mask requirements in schools and businesses.
Ladapo has long been skeptical
about COVID vaccines as well.
In the past, his warnings were met with a
public letter written by the FDA and CDC, .
In the past, his warnings were met with a
public letter written by the FDA and CDC, .
saying that his comments were "incorrect, misleading
and could be harmful to the American public,"
'The Washington Post' reports.
Credit: Wibbitz Top Stories Duration: 01:30Published
FDA Warns Companies to, Stop Selling Potentially Dangerous, , Unapproved Eye Drops.
Gizmodo reports that the United States Food and
Drug Administration (FDA) has warned several companies
to stop selling unapproved eye drop products.
On September 12, the FDA announced that it had
issued warning letters to eight companies
regarding the potentially dangerous products.
The companies, including major retail chains CVS and
Walgreens, have allegedly committed a number of
violations by marketing or manufacturing these products.
The companies, including major retail chains CVS and
Walgreens, have allegedly committed a number of
violations by marketing or manufacturing these products.
The companies, including major retail chains CVS and
Walgreens, have allegedly committed a number of
violations by marketing or manufacturing these products.
The FDA has also expressed concerns over silver
compounds found in some of the products, which can
turn people's skin or eyes blue with long-term use.
According to the FDA, some of the eye drop products
were allegedly manufactured at facilities that have
failed to meet standard safety and quality guidelines.
The FDA is particularly concerned that these
illegally marketed, unapproved ophthalmic
drug products pose a heightened
risk of harm to users because drugs
applied to the eyes bypass some
of the body’s natural defenses, Food and Drug Administration, via statement.
The FDA is particularly concerned that these
illegally marketed, unapproved ophthalmic
drug products pose a heightened
risk of harm to users because drugs
applied to the eyes bypass some
of the body’s natural defenses, Food and Drug Administration, via statement.
Gizmodo reports that the companies
have 15 days to respond with their
plans to correct the alleged violations.
If the companies fail to respond, the FDA could
take further action to either seize or stop the
manufacturing of the products in question.
When we identify illegally marketed,
unapproved drugs and lapses in drug
quality that pose potential risks,
the FDA works to notify the
companies involved of the violations, Jill Furman, Director of the Office of Compliance for the FDA’s
Center for Drug Evaluation and Research, via Gizmodo.
We will continue to investigate potentially
harmful eye products and work to ensure
violative products stay off store shelves
so that consumers can continue taking
the medicines they need without concern, Jill Furman, Director of the Office of Compliance for the FDA’s
Center for Drug Evaluation and Research, via Gizmodo.
We will continue to investigate potentially
harmful eye products and work to ensure
violative products stay off store shelves
so that consumers can continue taking
the medicines they need without concern, Jill Furman, Director of the Office of Compliance for the FDA’s
Center for Drug Evaluation and Research, via Gizmodo
Credit: Wibbitz Top Stories Duration: 01:30Published
FDA Says Popular , Nasal Decongestant , Not Effective Treatment For Congestion.
Associated Press reports that government experts
found that the number one decongestant in
the United States does not alleviate a stuffy nose. .
Associated Press reports that government experts
found that the number one decongestant in
the United States does not alleviate a stuffy nose. .
On September 12, advisers for the Food and
Drug Administration voted unanimously
against the effectiveness of phenylephrine.
Phenylephrine is found in a number
of popular over-the-counter products,
including Sudafed, Allegra and Dayquil.
Modern studies,
when well conducted,
are not showing any improvement
in congestion with phenylephrine, Dr. Mark Dykewicz, Allergy specialist at the Saint Louis
University School of Medicine, via Associated Press.
AP reports that a team of outside advisers
were assembled by the FDA to take a closer
look at the effectiveness of phenylephrine.
Phenylephrine became the key ingredient in decongestants in 2006, when pseudoephedrine
was ordered to be moved behind pharmacy counters.
Phenylephrine became the key ingredient in decongestants in 2006, when pseudoephedrine
was ordered to be moved behind pharmacy counters.
The change came after a 2006 law called
for the change, as pseudoephedrine can
be used to produce methamphetamine. .
The change came after a 2006 law called
for the change, as pseudoephedrine can
be used to produce methamphetamine. .
AP reports that pending the FDA's decision,
drugmakers like Johnson & Johnson and Bayer could
be ordered to pull oral medications with phenylephrine. .
AP reports that pending the FDA's decision,
drugmakers like Johnson & Johnson and Bayer could
be ordered to pull oral medications with phenylephrine. .
According to the FDA's panel of experts,
consumers would need to be educated on
remaining options for treating congestion.
Patients require and deserve
medications that treat their
symptoms safely and effectively
and I don’t believe that
this medication does that, Jennifer Schwartzott, the patient representative
on the FDA panel, via Associated Press
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Approves New COVID Boosters , Ahead of Expected Winter Surge in Cases.
On September 11, the United States Food
and Drug Administration approved updated
COVID boosters from both Pfizer and Moderna.
NBC reports that the new boosters
are specifically formulated to
target the XBB.1.5 subvariant. .
The updated shots are expected to be available
later this week, pending the approval of
the Centers for Disease Control and Prevention.
According to the FDA, anyone over the age of five is
eligible to receive either company's booster shot,
regardless of if they were previously vaccinated.
The FDA also advised that vaccinated
individuals should wait at least two months
before receiving the updated booster. .
NBC reports that the news comes as
the U.S. faces a rising number of cases,
as a result of a number of new subvariants.
Officials have expressed hope that
the new boosters could potentially
stave off a spike in winter infections. .
On September 12, a CDC advisory committee is
scheduled to convene for a vote on recommendations
for who should receive the booster. .
On September 12, a CDC advisory committee is
scheduled to convene for a vote on recommendations
for who should receive the booster. .
NBC reports that CDC Director Dr. Mandy Cohen is
expected to approve those recommendations,
opening the door for vaccinations to begin.
NBC reports that CDC Director Dr. Mandy Cohen is
expected to approve those recommendations,
opening the door for vaccinations to begin.
According to experts, those who haven't had a booster
since last fall, as well as those who haven't had a recent
case of COVID, should get the booster as soon as possible.
Credit: Wibbitz Top Stories Duration: 01:31Published
California Announces Contract , to Produce Its Own Affordable Insulin.
CBS News reports that on March 18,
Gov. Gavin Newsom announced that
California has struck a 10-year deal with
nonprofit drug..
Credit: Wibbitz Top Stories Duration: 01:31Published
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