Sentences with phrase «drug label warnings»

V. Mensing found that federal law preempts state law claims resulting from allegedly inadequate drug label warnings about possible side effects.

Not exact matches

She said Janssen has acted responsibly regarding its opioid pain medications, which are approved by the U.S. Food and Drug Administration and carry FDA - mandated warnings on their labels about the drugs» known risks.

In fact, the group, along with the National Alliance for Breastfeeding Advocacy, went as far as to petition the Food and Drug Administration in 2008 to require warning labels on omega - 3 — fortified infant formulas.

The U.S. Food and Drug Administration has strengthened the label warning to state that breastfeeding is not recommended while using medicines containing codeine or tramadol because of the potential for serious adverse effects in the infant due to opioid overdose (76).

Ask the Food and Drug Administration to include labeling on powdered infant formula warning that it is not sterile and providing instructions on how to properly reconstitute it.

The U.S. Food and Drug Administration originally approved the drug in 1999, but subsequent case reports of abnormal behavior in adolescents who used the medication led the agency in 2006 to require that all packaging of the drug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicDrug Administration originally approved the drug in 1999, but subsequent case reports of abnormal behavior in adolescents who used the medication led the agency in 2006 to require that all packaging of the drug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicdrug in 1999, but subsequent case reports of abnormal behavior in adolescents who used the medication led the agency in 2006 to require that all packaging of the drug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicdrug include a warning label about potential neuropsychiatric side effects, such as hallucinations, delirium, self - harm and even suicide.

For all the talk of focus and memory and tranquil sleep on the labels, almost all the containers carry the same warning, typically in small type at the bottom: «These statements have not been evaluated by the Food and Drug Administration.

In October federal health officials announced that antidepressants must carry a black box label — the Food and Drug Administration's strongest warning — indicating the drugs can cause suicidal behavior in children and teenagers.

NSAID labels include warnings about potential increases in blood pressure but there is little data on the effects of individual drugs.

The Food and Drug Administration decided June 20 to expand labeling on testosterone products to include a general warning about the risk of blood clots in veins.

Both drugs have been associated with serious harms; both drugs» labels include warnings about memory, attention or language problems and depression.

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.

Last May, a group of advisers to the Food and Drug Administration concluded that Halcion was safe and effective when used correctly, but that the warning on the label should be strengthened.

Because of those interactions, the FDA demanded a series of warnings on the label and risk - evaluation and mitigation strategies for providers, which means a short educational course before they are allowed to prescribe or dispense the drug.

Two days later, the FDA, which had already been assessing the health risks of Avandia, imposed its toughest warning label, the «black box,» on the drug, as well as on Actos, another drug used to treat diabetes.

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.

Drug Labels FDA drug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingredieDrug Labels FDA drug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingredLabels FDA drug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug labels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingredlabels contain the name of the particular symptom, disease, or subset of patients within a disease that the drug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug is approved to treat, along with instructions for using the drug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug properly (including the dosage and what to do when a patient misses a dose), a description of any special instructions for taking the drug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug (such as with food or water), storage instructions, the symptoms of side effects to the drug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug, the names of any conditions or foods the patient should not have while using the medication, any warnings or precautions, any risk of drug tolerance or dependency, and a list of drug ingrediedrug tolerance or dependency, and a list of drug ingrediedrug ingredients.

However, the Food and Drug Administration in 2006 asked the manufacturers of stimulants, including Adderall, to add a warning to their label saying the medications should not be used in children with structural heart abnormalities or other heart problems.

The Food and Drug Administration (FDA) really has not acknowledged the negative impact of cancer - causing acrylamides, and food manufacturers, so far, are not putting warning labels on their products concerning the levels of acrylamides, either.

For example, the Food and Drug Administration (FDA) now requires statin drugs to carry labels warning of their association with type 2 diabetes, confusion, memory loss, and muscle pain.

Though in 2011 the US FDA (Food and Drug Administration) voted against putting warning labels on foods containing synthetic dyes in the US, some American stores such as Whole Foods do not sell products containing artificial dyes.

The FDA is beefing up its warning label requirements for addictive opioid drugs like Vicodin and Percocet.

Now the U.S. Food and Drug Administration has warned the company that makes it about the labeling and safety of its product.

Like all powerful over-the-counter drugs, Behind Her Eyes deserves its own warning label.

The warning labels on heartworm medications are very clear: if you or your child should accidentally ingest the drugs, you'd better rush to the doctor immediately.

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 prodDrug 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 proddrug but issues a black box warning label, drug manufacturers can still be held financially liable for injuries linked directly to the use of their proddrug manufacturers can still be held financially liable for injuries linked directly to the use of their product.

The jury held Mutual Pharmaceutical liable for not realizing Sulindac's unreasonable danger to consumers, and the company modified the drug's warning label to include SJS / TEN as a possible side - effect.

However, although the US Food and Drug Administration has authorized Boehringer Ingelheim to update Pradaxa's drug label, which includes a warning that there is no reversal agent, where is the warning that the blood thinner comes with the risk of hemorrhaging and even deDrug Administration has authorized Boehringer Ingelheim to update Pradaxa's drug label, which includes a warning that there is no reversal agent, where is the warning that the blood thinner comes with the risk of hemorrhaging and even dedrug label, which includes a warning that there is no reversal agent, where is the warning that the blood thinner comes with the risk of hemorrhaging and even death?

Collectively, these studies prompted the FDA to issue a drug safety communication in March 2015 revealing that new warning labels will be added to low testosterone drugs regarding the possible increased risk of cardiovascular complications.

Since November 2010 I've been following here and here the effort of the Food and Drug Administration to require nine new and quite graphic warning labels on cigarette packs and advertisements.

Since November 2010 I've been following here and here and here the effort of the Food and Drug Administration to require nine new, graphic warning labels on cigarette packs and advertisements.

These injuries may be a result of a defect in the drug, or because of incomplete labeling or insufficient warnings.

In response to the release of this information, AbbVie issued a statement that it is adding an updated warning label to the drugs in question.

The Food and Drug Administration (FDA) added warnings about permanent alopecia (hair loss) to the drug's label in 2Drug Administration (FDA) added warnings about permanent alopecia (hair loss) to the drug's label in 2drug's label in 2015.

Officials of J&J's Janssen unit, which sells Risperdal, said the drug's safety label contained proper warnings about the breast side effect.

An example might include a drug manufacturer or pharmacist failing to label with a warning a prescription drug that might make you too drowsy to drive.

In addition to AbbVie's responsibility to update labels and provide warning of serious side - effects, healthcare professionals should also use extra caution when prescribing these drugs.

Failure to properly warn of the diabetes risk on the drug's label, even after the FDA's edict to include that information.

In February of 2012, the U.S. Food and Drug Administration (FDA) ordered Lipitor manufacturers, as well as other statin drug manufacturers, to post a warning label on the outside of the bottle, warning both healthcare professionals and patients of the risk of Type 2 diabeDrug Administration (FDA) ordered Lipitor manufacturers, as well as other statin drug manufacturers, to post a warning label on the outside of the bottle, warning both healthcare professionals and patients of the risk of Type 2 diabedrug manufacturers, to post a warning label on the outside of the bottle, warning both healthcare professionals and patients of the risk of Type 2 diabetes.

In late 2015, there was a new requirement that imposed new warning labels of Invokana and similar diabetes drugs warning patients to discontinue use if they experienced signs of ketoacidosis.

Defective pharmaceuticals are described as causing physical or emotional injury that was not apart of any labeling or warning issued by the pharmaceutical company producing the drug.

That's because the warning and usage labels are created by the brand name manufacturer, but because brand name manufacturers aren't the ones making the drugs at issue, many courts have held they can not be liable.

Other times, insufficient or misleading warning labels adorn the bottles, which can cause patients to inadvertently abuse their drugs.

J & J's Janssen unit, however, is adamant that unlike what Pledger's family and other plaintiffs are claiming, the medication's Food and Drug Administration - approved label did properly warn about the possible risks.

[9] The potential lifelong side effects of this drug were not disclosed within the brand - name manufacturer's nor the mirrored generic manufacturer's warning label.

[16] The SJC considered innovator liability to require such a modification given the certainty that a user of a generic drug will rely on the label fashioned by the brand - name manufacturer and as state law shields failure to warn claims from generic manufacturers, leaving plaintiffs without recourse for their injuries.

Specifically, in Rafferty v. Merck & Co., Inc., [4] the SJC held that plaintiffs who ingest the generic form of a drug may bring failure to warn claims against the brand - name manufacturer of the drug if the brand - name defendant acted recklessly by «intentionally fail [ing] to update the label on its drug while knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.»

This new warning will soon be added to the drug's label.

The Pennsylvania Record reports that the lawsuit argues that Boehringer Ingelheim knew or should have known that the original labeling of the drug did not adequately warn the plaintiff of the risks associated with Pradaxa.

Relevant to the matter considered by the SJC, the Drug Price Competition and Patent Term Restoration Act, informally known as the «Hatch - Waxman Act» requires the «manufacturer of a generic drug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.&raDrug Price Competition and Patent Term Restoration Act, informally known as the «Hatch - Waxman Act» requires the «manufacturer of a generic drug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.&radrug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.»