Quotes from the news wire:
In order to safely prescribe Paxlovid, the potential for DDIs needs to be considered by all prescribers, both to take actions to manage DDIs and also to determine whether Paxlovid is an appropriate treatment choice for each individual patient when factoring in the risks of serious adverse reactions due to DDIs.
Found on CNN 1 year ago
The idea is to provide information you can discuss with your provider to make better informed decisions, including if you need to consider any next steps.
Found on CNN 1 year ago
Given the higher than background rate of GBS observed in the Phase 3 study, FDA will recommend a postmarketing study and enhanced surveillance for further evaluation of GBS and other immune-mediated demyelinating conditions with postmarketing use.
Found on CNN 1 year ago
Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine. … Therefore, [Guillain-Barre] is being considered an important potential risk.
Found on CNN 1 year ago
We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.
Found on CNN 1 year ago
This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication.
Found on CNN 1 year ago
Drug shortages can occur for many reasons, including manufacturing and quality problems, delays and discontinuations, manufacturers provide FDA [with] most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages.
Found on FOX News 2 years ago
Looking in the past doesn't help us a great deal to look in the future for this virus which has baffled a lot of us and made predictions almost irrelevant.
Found on CNN 2 years ago
The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions and information gaps about patient health status and clinical management of the patient.
Found on FOX News 2 years ago
In Trial AA-1, 22% of the 184 patients who received 2 milligrams of Olumiant and 35% of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 5% of the 189 patients who received a placebo. In Trial AA-2, 17% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 3% of the 156 patients who received a placebo.
Found on FOX News 2 years ago
We recognize parents are anxious to have their young children vaccinated against COVID-19, and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach.
Found on FOX News 2 years ago
The emergency use authorization allows the vaccine to be distributed in the U.S. for use in individuals 18 years and older.
Found on CNN 2 years ago
In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.
Found on FOX News 2 years ago
The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, two of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group.
Found on FOX News 3 years ago
Additionally, peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant, authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.
Found on FOX News 3 years ago
RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term, early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity.
Found on FOX News 3 years ago
Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals.
Found on FOX News 3 years ago
Under this outbreak situation, the demand is enormous both from hospitals and the general public. The volume of illegal gloves we have found is enormous.
Found on CNN 3 years ago
While today's action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or' FDA approved.' All tobacco products are harmful and addictive and those who do not use tobacco products should not start.
Found on CNN 3 years ago
Concerns have been raised that declining neutralizing antibody titers or reduced effectiveness against symptomatic disease may herald significant declines in effectiveness against severe disease.
Found on CNN 3 years ago
Children are not small adults -- and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults.
Found on CNN 3 years ago
Finally, the VRBPAC will be asked to discuss circumstances under which emergency use authorization could be considered for age groups within 6 months to 12 years and, in that context, data needed to support benefits of making COVID-19 vaccines available under emergency use authorization and safety data needed to assess risks.
Found on CNN 3 years ago
Beech-Nut is concerned about the ability to consistently obtain rice flour well-below the FDA guidance level and Beech-Nut specifications for naturally occurring inorganic arsenic.
Found on CNN 3 years ago
Beech-Nut has also decided to exit the market for Beech-Nut branded Single Grain Rice Cereal.
Found on CNN 3 years ago
The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages, alzheimer’s is the sixth-leading cause of death in the United States.
Found on FOX News 3 years ago
The guidance also provides recommendations to test developers, such as considering the potential for future viral genetic mutations when designing their test, and conducting their own routine monitoring to evaluate the potential impact of new and emerging viral genetic mutations, which may be the basis of viral variants, on the performance for molecular, antigen and serology SARS-CoV-2 tests.
Found on FOX News 3 years ago
Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may be authorized without the need for clinical studies.
Found on FOX News 3 years ago
Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.
Found on FOX News 3 years ago
Patients should not stop taking tofacitinib without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.
Found on FOX News 3 years ago
The FDA will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients.
Found on FOX News 4 years ago
The FDA remains committed to advancing the nation's public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system.
Found on CNN 4 years ago
Based on the FDA's review of the totality of the scientific evidence available, the agency determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate Covid-19, and, when used to treat Covid-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug. There are no adequate, approved and available alternative treatments to bamlanivimab for the authorized population.
Found on CNN 4 years ago
This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black orAfrican American.
Found on FOX News 4 years ago
Manufacturers' failure to immediately recall all potentially affected products is placing consumers in danger of methanol poisoning, a warning letter has been issued to Eskbiochem S.A. de C.V. for distributing product with undeclared methanol, unapproved claims -- including incorrectly stating The FDA approval — and improper manufacturing practices.
Found on CNN 4 years ago
We are continuing to adapt our approach based on real-world experience and data and so, as The FDA has authorized more antibody tests and validation data have become available, including through the capability at National Cancer Institute, the careful balancing of risks and benefits has shifted from where The FDA was in mid-March.
Found on CNN 4 years ago
Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety.
Found on Reuters 4 years ago
One concern with impurities data submitted by some fuel ethanol companies is the unacceptable levels of known carcinogens( cancer causing agents), such as benzene, as well as formulas containing gasoline.
Found on CNN 4 years ago
Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.
Found on CNN 4 years ago
We are also aware of increased use of these medicines through outpatient prescriptions, therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.
Found on CNN 4 years ago
While clinical trials are ongoing to determine the safety and effectiveness of these drugs for Covid-19.
Found on CNN 4 years ago
We are dependent on manufacturers to take steps to ensure the safety of their products.
Found on Reuters 5 years ago
They have healthy eyes. They could go and get a pair of glasses.
Found on FOX News 5 years ago
Consumers are urged to avoid buying vaping products on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.
Found on Reuters 5 years ago
Miracle Mineral Solution and similar products are not FDA-approved, and ingesting these products is the same as drinking bleach.
Found on CNN 5 years ago
Hepatitis A virus can result in a liver infection that may be inapparent. However, when symptoms occur, they can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months.
Found on CNN 5 years ago
Measuring PFAS concentrations in food, estimating dietary exposure and determining the associated health effects is an emerging area of science.
Found on FOX News 5 years ago
Although we have not established a price for Ruzurgi, it remains our goal to ensure that Ruzurgi is affordable and available to pediatric patients living with LEMS.
Found on CNN 5 years ago
We all share the important responsibility of keeping harmful and addictive tobacco products out of the hands of kids. Retailers in particular are on the frontlines of these efforts to reduce the health consequences of tobacco use and nicotine dependence.
Found on Reuters 5 years ago
We also want to know how many cosmetics products contain talc and whether manufacturers have received adverse event reports associated with talc-containing products.
Found on Reuters 5 years ago
Having everyone informed about this is in the best interest of the patient.
Found on FOX News 5 years ago
A few years ago, it would've been incredible to me that we would be here today discussing the potential for drug therapy to help addicted young people quit.
Found on CNN 6 years ago
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
Found on CNN 6 years ago
Liquid nitrogen, although non-toxic, can cause severe damage to skin and internal organs if mishandled or accidently ingested due to the extremely low temperatures it can maintain, inhaling the vapor released by a food or drink prepared by adding liquid nitrogen immediately before consumption may also cause breathing difficulty, especially among individuals with asthma.
Found on FOX News 6 years ago
We have n’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.
Found on FOX News 6 years ago
We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal' rejuvenation' and/or cosmetic vaginal procedures, the safety and effectiveness of energy-based medical devices to perform these procedures has not been established.
Found on CNN 6 years ago
This product is commonly found in plastic tubs and may be labeled as' pre-cooked,'.
Found on CNN 6 years ago
Failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.
Found on CNN 7 years ago
These medications carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.
Found on CNN 7 years ago
All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants, most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
Found on FOX News 7 years ago
Although most cosmetics on the market in the United States generally already contain less than 10 ppm of lead, a small number contained higher amounts, and we are aware that some cosmetics from other countries contain lead at higher levels.
Found on FOX News 8 years ago
We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented.
Found on Reuters 8 years ago
What and how much people eat and drink has changed since the last serving size requirements were published in 1993.
Found on Reuters 8 years ago
Today's actions... one of many steps The FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.
Found on Reuters 8 years ago
Nothing is of greater concern to Kimberly-Clark than the quality of our products and the well-being of the consumers who use them.
Found on CNN 9 years ago
Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury.
Found on Reuters 9 years ago
This (vulnerability) could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.
Found on Reuters 9 years ago
The drug works by reducing the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9's ability to work, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels.
Found on CNN 9 years ago
The reason they got warning letters is not what is or isn't in the product, it's because they made therapeutic claims.
Found on Reuters 9 years ago
Biosimilars will provide access to important therapies for patients who need them, patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.
Found on FOX News 9 years ago
Biosimilars will provide access to important therapies for patients who need them, patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy and quality standards.
Found on Reuters 9 years ago
No test is perfect, given the probability of erroneous results and the rarity of these mutations, professional societies typically recommend that only prospective parents with a family history of a genetic disorder undergo carrier screening.
Found on Reuters 9 years ago
This can be a problem, since even one small bite of a product containing milk can cause a dangerous reaction in some individuals.
Found on FOX News 9 years ago
It increases the quality and objectivity of the analysis of estimated benefits.
Found on Reuters 10 years ago
The two contraindications help to clarify the narrow population of patients in which laparoscopic power morcellation may be an appropriate therapeutic option, for example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may be candidates for this procedure.
Found on Reuters 10 years ago
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