Sentences with phrase «box warning»

A "box warning" is a warning label that is placed on a medication's packaging or label. It is used to alert healthcare providers and patients about serious or potentially life-threatening risks associated with the use of the medication. It is called a "box warning" because the warning is usually placed inside a boxed section on the packaging to make it more noticeable. Full definition
The manufacturer recently added a black box warning stating that it is not to be used in cats past a single injection.
These drugs carry a black box warning because they can increase risk of death in dementia patients.
There's an excellent reason why every toothpaste box warns you to only use a pea - sized portion and never swallow the contents.
However, in 2008, the FDA implemented a black box warning about ADT use for prostate cancer due to evidence that suggested an increased risk in non-fatal cardiovascular events.
These include a 2004 FDA «black box» warning regarding suicidality risk, 2005 public health advisory regarding potential for cardiovascular risks involving amphetamines, and a 2006 FDA Advisory Committee recommendation (later reversed) for a black box warning on psychostimulants linking these drugs to possible heart problems.
The FDA's mandated black box warning for Levaquin stems from reports of tendon injuries.
FDA Black Box Warning added to Levaquin alerting consumers and doctors of tendon ruptures.
The authors speculate that if use of varenicline had not plummeted by 76 percent following the black box warning in 2009, perhaps 17,000 premature deaths from cardiovascular disease may have been avoided each year during the last few years.
Rosemary Johann - Liang, a former FDA drug safety supervisor, had recommended a black box warning label for Avandia due to its harmful effects on the heart one year prior to Nissen's publication.
Developers often resort to issuing Windows-esque dialog boxes warning users of their systems being prone to serious malware infections and other threats, thereby luring unsuspecting users to download various apps.
IMPORTANT SAFETY INFORMATION: Due to serious human safety and abuse concerns, including physical or psychological dependence, life - threatening respiratory depression and additive CNS depressant effects, read the full prescribing information before using this drug, including the complete Boxed Warning.
In 2009, however, varenicline received a black box warning by the FDA based on their adverse event reports of neuropsychiatric symptoms like depression and thoughts of suicide.
But Valeant's desire to rack up a blockbuster treatment could run afoul of a black box warning imposed by the FDA because Siliq users experienced an increase in suicidal thoughts.
Just a few months ago, the FDA removed the black box warning from varenicline.
Yet according to Johann - Liang, «my recommending a heart failure box warning was not well received by my superiors, and I was told that I would not be overseeing that project.»
Then, in August, the FDA announced that it would require all TNF blockers to carry a so - called black - box warning stating that the drugs cause an increased risk of lymphoma and other cancers in children and adolescents.
Buyer Be Aware: Reglan Gets a Black Box Warning Reglan (metoclopramide), a drug prescribed for heartburn, and sometimes to nursing mothers, can cause an irreversible nervous system disorder called tardive dyskinesia and other unacceptable side effects.
Fixed bug where after changing colors in the Customization menu, pressing Esc, cancelling the message box warning about not applying changes, and hitting Apply no button would be selected
Instead, there has been a black box warning placed on the drug label that describes the risk of Tardive Dyskinesia, even after the drug is stopped.
The FDA has required the maker of Depakote to include a strong black box warning alerting doctors and patients to the potential for life - threatening side effects associated with Depakote use including serious birth defects such as anencephaly (brainless babies) and spina bifida.
In fact, Actos carries a black box warning concerning its potential risk of causing or worsening congestive heart failure.
FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Turok is coming to Xbox One, the ESRB now posts on - the - box warnings about microtransactions and loot boxes, and PS Plus is offering great games for March.
2006 - In 2006 Public Citizen and the Illinois Attorney General teamed up to petition the FDA, seeking once again to have black box warnings added to fluoroquinolones.
Even in cases where the Food and Drug Administration (FDA) does not formally recall a drug but issues a black box warning label, drug manufacturers can still be held financially liable for injuries linked directly to the use of their product.
You'll get a dialog box warning you that the new partition will not work in Windows (Remember when we told you that creating partitions on an SD card for installing apps directly to the card is different from partitioning a drive for use on a Windows PC?).
WARNINGS, PRECAUTIONS and CONTRAINDICATIONS: Due to serious human safety and abuse concerns, including physical or psychological dependence, life - threatening respiratory depression and additive CNS depressant effects, read the full prescribing information before using this drug, including the complete Boxed Warning.
The most commonly used and effective classes of medication, triptans and DHE (Dihydroergotamine), however, have a black box warning for two subtypes of migraine because of risk of stroke.
All TCAs carry a black box warning about an increased risk of suicidal thinking and behavior in people under the age of 25.
And Viagra, which can lead to side effects like dizziness and nausea, does not carry a black - box warning.
I wish that the Prime Minister could waive his magic wand and make formula a prescription item that is carried not just behind the counter but must be kept under it so you can't view the brand names and it must carry a black box warning on it.
This is a black - box warning,» Moritz said, referring to the requirement that a special warning be included on the drug's packaging.
Of note, safety labeling changes for extended - release and long - acting opioid analgesics announced by the FDA in September will highlight the risk for neonatal opioid withdrawal syndrome (NOWS) in a boxed warning.
If you look at the black - box warning on a packet of birth control pills, you'll notice that at most ages the risk of death from taking the pills is less than if you don't take them — that's because they're so good at preventing pregnancy, and pregnancy kills.
They note that the drug comes with a black - box warning that women may suffer severe low blood pressure or faint if they take the drug with alcohol, certain medications or have liver problems.
For now, FDA has cautioned users with a black - box warning.
The Food and Drug Administration (FDA) issued a Drug Safety Communication in September 2013 that read, «Boxed warning and new recommendations to decrease risk of hepatitis B reactivation with the immune - suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab).»
Black - box warnings about the dangers of attention - deficit hyperactivity disorder (ADHD) medications are confusing and could have serious consequences for the risk of youth suicide, according to researchers at the Institut universitaire en santé mentale de Montréal (CIUSSS de l'Est - de - l'Île - de-Montréal) and the University of Montreal, whose correspondence has just been published in the most recent issue of the journal The Lancet Psychiatry.
«Health Canada has issued a series of black - box warnings about the suicidal potential of ADHD medications.
A fifth of all drugs receive a black boxed warning (the highest level of warning on a drug's label) after approval, and 4 percent of drugs are ultimately withdrawn for safety reasons.
The generic risperidone products will have the same safety warnings as Risperdal, including a boxed warning, cautioning that older patients with dementia - related psychosis treated with atypical anti-psychotic drugs are at increased risk of death, as compared with those taking placebo.
The boxed warning also includes an increased risk of death following hematopoietic stem cell transplantation.
Inotuzumab ozogamicin includes a boxed warning due to the risk of severe hepatotoxicity, including sinusoidal obstruction syndrome or veno - occlusive disease (VOD).

Phrases with «box warning»

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