DBV Technologies (DBVT+2.8%) says the Food and Drug Administration has accepted the Biologics License Application for its Viaskin peanut immunotherapy for the treatment of peanut-allergic children aged 4-11; shares are halted.
If approved, Viaskin Peanut would be the first and
only epicutaneous immunotherapy indicated for the potentially
life-threatening condition in children.
DBV says the FDA plans to hold an advisory
committee meeting to discuss the application, with a target action date
of Aug. 5, 2020.
SmileDirectClub (SDC+5.1%) responds
to statements made by some dental trade organizations and allegations
in a lawsuit filed in Nashville federal court that question the safety
and legitimacy of the company’s teledentistry platform.
“There is no factual basis nor scientific or
medical justification in these allegations to substantiate the false
claims made about our model and the state-licensed doctors in our
affiliated network,” the company said in a statement.
It blames the allegations on anticompetitive
campaigns and notes that previous complaints filed with state dental
boards and federal government institutions by dental trade organization
and others “have gone nowhere.”
Some dental patients who were inappropriately given antibiotics prior
to procedures suffered adverse events potentially connected to the
drugs, such as anaphylaxis and Clostridioides difficile infection, researchers said here.
Of patients inappropriately prescribed antibiotic prophylaxis prior
to a dental procedure, almost 4% had adverse events ranging from new
allergies and emergency department visits to anaphylaxis and C. difficile infection, reported Alan Gross, PharmD, of the University of Illinois at Chicago (UIC).
Dentists prescribe 10% of antibiotics in the U.S., and are the
largest specialty prescriber, said co-author Katie Suda, PharmD, of UIC
College of Pharmacy, speaking at a press conference at the IDWeek meeting, with joint sponsorship by the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, the Society for Healthcare Epidemiology of America (SHEA), and the HIV Medicine Association.
To put that into perspective, she added, pediatricians and internists prescribe 10%-12% of all antibiotics in the U.S.
“[We need] awareness of other providers out there that need to be
pulled into the fold and have an awareness as part of stewardship,”
Thomas Talbot, MD, of SHEA, told MedPage Today. “The layers of
the onion of stewardship need to broaden out and there are undoubtedly
other clinicians similar to this that we need to identify and help …
understand stewardship.”
This was a follow-up analysis to a prior study on inappropriate
antibiotic prescribing, which found that over 80% of antibiotic
prescriptions for prophylaxis prior to dental visits were unnecessary.
Suda pointed to data from the CDC, which found that antibiotic
prescribing among dentists has remained stable, while prescribing among
physicians has declined. In fact, she noted that their study found that
clindamycin was the most likely to be overprescribed. Dentists are the
top prescriber of clindamycin, which is associated with the highest risk
for C difficile infection, she said.
“Dentists are a very unique prescriber group. Not only are they
pressured to prescribe antibiotics from their patients, but from other
clinicians,” Suda said at the press conference.
And in some cases, those guidelines may be outdated. She said that
orthopedic surgeons used to recommend one dose of antibiotics prior to a
dental visit if the patient had a prosthetic joint, such as a
prosthetic knee, but those guidelines have changed.
The American Heart Association guidelines have also narrowed over
time, Suda said, with fewer patients with cardiac conditions now
indicated to receive an antibiotic prior to a dental visit. These
guidelines now apply to patients with cardiac conditions considered to
be at the highest risk of adverse outcomes if the patient gets infective
endocarditis, such as those with prosthetic heart valves, and generally
for “invasive dental procedures.”
“This study illustrates the perception that antibiotics are fairly
benign, even if it’s just one dose,” Talbot said at the press
conference. “We need to have those conversations … [that] it’s not a
harmless decision to give antibiotic prophylaxis for just one dose;
there can be some consequences.” Study Details
Gross and colleagues examined data from 2011 to 2015 of patients with
dental visits linked to medical and prescription claims. In this study,
researchers looked at unnecessary antibiotic prophylaxis — defined as
antibiotic prophylaxis in patients who both did not undergo a procedure
that manipulated the gingiva/tooth periapex and did not have an
appropriate cardiac diagnosis.
Of the 168,420 dental visits with antibiotic prophylaxis, 136,177
were unnecessary, and of those, 3.8% of unnecessary prescriptions were
associated with an antibiotic-related adverse event. The most common
adverse events were new allergies (2.9%) and emergency department visits
(1.2%).
The researchers also specifically looked at clindamycin versus
azithromycin. Suda noted that in their previous study, clindamycin was
most likely to be overprescribed and was associated with a 34% increased
risk of a serious adverse drug event versus amoxicillin.
Suda noted that their data was a “conservative estimate,” because the
study only measured patients where patients sought healthcare, and
didn’t include adverse events such as nausea or diarrhea, nor did it
include drug/drug interactions.
“If patients have adverse events, they’re not going back to the
dentist — they’re seeing their primary care provider or going to the
emergency department,” she noted. “Dentists never see those adverse
outcomes … but we should try to provide dentists with more streamlined
access to a patient’s medical information. Very few dental offices have
that available to them.”
Gross and Sudha disclosed no conflicts of interest.
One co-author disclosed support from BioK+.
SmileDirectClub (NASDAQ:SDC) slides 4.2% after short report by Hindenburg Research sees 85% downside for the stock.
Report says Alabama and Georgia dental board have
enacted rules that allegedly make the company’s practices illegal;
Hindenburg expects other states to follow.
