PatientsVille.com Logo

Definity Side Effects

PatientsVille

Common Definity Side Effects


The most commonly reported Definity side effects (click to view or check a box to report):

Back Pain (653)
Dyspnoea (116)
Urticaria (103)
Flushing (88)
Chest Pain (83)
Headache (71)
Muscle Spasms (64)
Pruritus (58)
Dizziness (57)
Pain In Extremity (55)
Nausea (48)
Hypotension (43)
Arthralgia (40)
Chest Discomfort (36)
Cardiac Arrest (34)
Rash (33)
Hyperhidrosis (32)
Feeling Hot (30)
Blood Pressure Increased (26)
Erythema (24)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Definity Side Effects Reported to FDA



Definity Side Effect Report#9989473
Hypoxia, Syncope, Rales, Cardiac Failure, Condition Aggravated
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: echocardiogram, who was treated with Definity (dosage: 1 Vial Definity Diluted In 8 Ml, start time:
Oct 21, 2013), combined with:
  • Albuterol
  • Lasix
  • Pravachol
  • Coumadin
  • Plavix
  • Coreg
  • Tylenol
and developed a serious reaction and side effect(s): Hypoxia, Syncope, Rales, Cardiac Failure, Condition Aggravated after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Definity treatment in male patients, resulting in Hypoxia side effect. The patient was hospitalized.
Definity Side Effect Report#9842154
Lip Swelling, Rash, Rosacea
This report suggests a potential Definity Lip Swelling side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: echocardiogram and used Definity (dosage: NA) starting
Jan 02, 2014. After starting Definity the patient began experiencing various side effects, including: Lip Swelling, Rash, RosaceaAdditional drugs used concurrently: NA. Although Definity demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lip Swelling, may still occur.
Definity Side Effect Report#9813759
Pain, Heart Rate Increased, Dyspnoea, Muscle Spasms
This Pain problem was reported by a consumer or non-health professional from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: echocardiogram. On
Dec 17, 2013 this consumer started treatment with Definity (dosage: Iv Push). The following drugs were being taken at the same time: NA. When using Definity, the patient experienced the following unwanted symptoms/side effects: Pain, Heart Rate Increased, Dyspnoea, Muscle SpasmsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Definity Side Effect Report#9769185
Flushing, Restlessness, Swelling, Ocular Hyperaemia, Unevaluable Event
This Flushing side effect was reported by a consumer or non-health professional from US. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: echocardiogram.The patient was prescribed Definity (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Definity the consumer reported adverse symptoms, such as: Flushing, Restlessness, Swelling, Ocular Hyperaemia, Unevaluable EventThese side effects may potentially be related to Definity.
Definity Side Effect Report#9758411
Ejection Fraction Decreased, Anaphylactic Reaction
This is a report of a 84-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: echocardiogram, who was treated with Definity (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Ejection Fraction Decreased, Anaphylactic Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Definity treatment in male patients, resulting in Ejection Fraction Decreased side effect.
Definity Side Effect Report#9733092
Blood Pressure Decreased, Oxygen Saturation Decreased, Flushing, Rash
This report suggests a potential Definity (perflutren) Blood Pressure Decreased side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: echocardiogram and used Definity (perflutren) (dosage: 1 Vial Definity With 8.3 Ml Normal Saline (2 Ml), Intravenous Bolus) starting
Nov 21, 2013. After starting Definity (perflutren) the patient began experiencing various side effects, including: Blood Pressure Decreased, Oxygen Saturation Decreased, Flushing, RashAdditional drugs used concurrently:
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Aceon (perindopril Erbumine)
Although Definity (perflutren) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Decreased, may still occur.
Definity Side Effect Report#9684189
Muscle Spasms
This Muscle Spasms problem was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: echocardiogram. On
Sep 23, 2013 this consumer started treatment with Definity (dosage: NA). The following drugs were being taken at the same time: NA. When using Definity, the patient experienced the following unwanted symptoms/side effects: Muscle SpasmsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Spasms, may become evident only after a product is in use by the general population.
Definity Side Effect Report#9652188
Abdominal Pain, Muscle Rigidity, Unresponsive To Stimuli, Convulsion, Faecal Incontinence
This Abdominal Pain side effect was reported by a physician from US. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: echocardiogram.The patient was prescribed Definity (drug dosage: Undiluted 0.3 Ml, Intravenous Bolus), which was initiated on
Oct 15, 2013. Concurrently used drugs:
  • Albuterol (salbutamol)
  • Amiodarone
  • Lovenox (enoxaparin Sodium)
  • Advair (fluticasone Propionate, Salmeterol Xinafoate)
  • Lasix (furosemide)
  • Singulair
  • Aldactone (spironolactone)
  • Coreg (carvedilol)
.After starting to take Definity the consumer reported adverse symptoms, such as: Abdominal Pain, Muscle Rigidity, Unresponsive To Stimuli, Convulsion, Faecal IncontinenceThese side effects may potentially be related to Definity.
Definity Side Effect Report#9547479
Electrocardiogram St Segment Elevation, Right Ventricular Dysfunction, Anaphylactic Shock
This is a report of a 76-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: stress echocardiogram, who was treated with Definity (dosage: 1 Vial Of Definity Diluted 8.7 Ml Normal Saline (2ml) Intravenous Bolus, start time:
Sep 05, 2013), combined with:
  • Lisinopril (lisinopril)
  • Zocor (simvastatin)
and developed a serious reaction and side effect(s): Electrocardiogram St Segment Elevation, Right Ventricular Dysfunction, Anaphylactic Shock after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Definity treatment in male patients, resulting in Electrocardiogram St Segment Elevation side effect. The patient was hospitalized.
Definity Side Effect Report#9535950
Anaphylactic Reaction
This report suggests a potential Definity (perflutren) 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml), Intravenous B0lus Anaphylactic Reaction side effect(s) that can have serious consequences. A 31-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: stress echocardiogram and used Definity (perflutren) 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml), Intravenous B0lus (dosage: 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml ), Intravenous Bolus) starting 2001. After starting Definity (perflutren) 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml), Intravenous B0lus the patient began experiencing various side effects, including: Anaphylactic ReactionAdditional drugs used concurrently: NA. Although Definity (perflutren) 1 Ml Definity Diluted With 9 Ml Normal Saline (2 Ml), Intravenous B0lus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Reaction, may still occur.
Definity Side Effect Report#9532175
Respiratory Distress, Acute Pulmonary Oedema, Ejection Fraction Decreased, Mitral Valve Incompetence
This Respiratory Distress problem was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: echocardiogram. On NS this consumer started treatment with Definity (dosage: NA). The following drugs were being taken at the same time: NA. When using Definity, the patient experienced the following unwanted symptoms/side effects: Respiratory Distress, Acute Pulmonary Oedema, Ejection Fraction Decreased, Mitral Valve IncompetenceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Distress, may become evident only after a product is in use by the general population.
Definity Side Effect Report#9530754
Flushing, Dyspnoea, Nausea
This Flushing side effect was reported by a health professional from US. A 22-year-old female patient (weight:NA) experienced the following symptoms/conditions: scan with contrast.The patient was prescribed Definity (drug dosage: NA), which was initiated on
Sep 13, 2013. Concurrently used drugs: NA..After starting to take Definity the consumer reported adverse symptoms, such as: Flushing, Dyspnoea, NauseaThese side effects may potentially be related to Definity.
Definity Side Effect Report#9500611
Back Pain, Muscle Spasms
This is a report of a 68-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: scan with contrast, who was treated with Definity (dosage: Given Once For Pre-stress Echo Images, start time:
Aug 28, 2013), combined with:
  • Acebutolol
  • Norvasc
  • Lipitor
  • Aspirin
  • Co-enzyme Q-10
  • Vitamin B12
  • Folic Acid
  • Mag-ox
and developed a serious reaction and side effect(s): Back Pain, Muscle Spasms after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Definity treatment in female patients, resulting in Back Pain side effect.
Definity Side Effect Report#9496468
Anaphylactic Reaction, Dysgeusia, Paraesthesia Oral, Rash, Hypotension
This report suggests a potential Definity Anaphylactic Reaction side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: echocardiogram and used Definity (dosage: 1 Vial Diluted With 8.5 Ml Of Normal Saline (2 Ml)) starting
Aug 15, 2013. After starting Definity the patient began experiencing various side effects, including: Anaphylactic Reaction, Dysgeusia, Paraesthesia Oral, Rash, HypotensionAdditional drugs used concurrently:
  • Albuterol (slbutamol)
  • Aspirin (acetylsalicylic Acid)
  • Cozaar (losartan Potassium)
  • Zocor (simvastatin)
  • Coreg (carvedilol)
  • Heparin (heparin)
Although Definity demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Reaction, may still occur.
Definity Side Effect Report#9478127
Anaphylactic Reaction
This Death problem was reported by a physician from US. A 65-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: echocardiogram. On
Aug 03, 2013 this consumer started treatment with Definity (dosage: NA). The following drugs were being taken at the same time:
  • Albuterol (salbutamol)
  • Aspirin (acetylsalicylic Acid)
  • Cortrosyn (tetracosactide)
  • Ferrus Sulphate (ferrous Sulfate)
  • Humulin (insulin Humam, Insulin Human Injection, Sophane)
  • Lovenox (enoxaparin Sodium)
  • Mag-all (magnesium Hydroxide, Simeticone, Aluminium Hydroxide)
  • Magnesium Oxide (magnesium Oxide)
When using Definity, the patient experienced the following unwanted symptoms/side effects: Anaphylactic ReactionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Definity Side Effect Report#9476376
Muscle Spasms
This Muscle Spasms side effect was reported by a pharmacist from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: diagnostic procedure.The patient was prescribed Definity (drug dosage: NA), which was initiated on
Aug 22, 2013. Concurrently used drugs: NA..After starting to take Definity the consumer reported adverse symptoms, such as: Muscle SpasmsThese side effects may potentially be related to Definity.
Definity Side Effect Report#9452339
Back Pain
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: scan with contrast, who was treated with Definity (dosage: NA, start time:
Aug 07, 2013), combined with: NA. and developed a serious reaction and side effect(s): Back Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Definity treatment in male patients, resulting in Back Pain side effect.
Definity Side Effect Report#9432024
Cardiac Arrest, Pulseless Electrical Activity, Ventricular Fibrillation, Bundle Branch Block Right, Atrioventricular Block Complete, Brain Injury
This report suggests a potential Definity Cardiac Arrest side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: echocardiogram and used Definity (dosage: NA) starting
Jul 11, 2013. After starting Definity the patient began experiencing various side effects, including: Cardiac Arrest, Pulseless Electrical Activity, Ventricular Fibrillation, Bundle Branch Block Right, Atrioventricular Block Complete, Brain InjuryAdditional drugs used concurrently: NA. Although Definity demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Arrest, may still occur.
Definity Side Effect Report#9422409
Presyncope, Hypotension, Dizziness, Posture Abnormal, Hypothyroidism, Hypokalaemia, Dehydration
This Presyncope problem was reported by a physician from US. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: echocardiogram. On
May 23, 2013 this consumer started treatment with Definity (dosage: NA). The following drugs were being taken at the same time:
  • Coumadin (warfarin Sodium)
  • Amiodarone (amiodarone)
  • Lasix (furosemide)
When using Definity, the patient experienced the following unwanted symptoms/side effects: Presyncope, Hypotension, Dizziness, Posture Abnormal, Hypothyroidism, Hypokalaemia, DehydrationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Presyncope, may become evident only after a product is in use by the general population.
Definity Side Effect Report#9364231
Dyspnoea, Oxygen Saturation Decreased
This Dyspnoea side effect was reported by a physician from US. A 48-year-old male patient (weight:NA) experienced the following symptoms/conditions: stress echocardiogram.The patient was prescribed Definity (drug dosage: 1.3 Ml Defintiy Diluted With 8.7 Ml Normal Saline (2.5 Ml), Intravenous Bolus), which was initiated on
Jun 06, 2013. Concurrently used drugs:
  • Flexeril (cyclobenzaprine Hydrochloride)
  • Vicodin
  • Fentanyl Patch (fentanyl)
  • Amlodipine (amlodipine)
.After starting to take Definity the consumer reported adverse symptoms, such as: Dyspnoea, Oxygen Saturation DecreasedThese side effects may potentially be related to Definity.
Definity Side Effect Report#9298216
Cough, Dyspnoea, Oxygen Saturation Decreased, Myocardial Infarction
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: echocardiogram, who was treated with Definity (dosage: 1.5ml Defintiy Diltued With 8.5 Ml Normal (3ml, Intravenous Bolus), start time:
Apr 30, 2013), combined with:
  • Simvastatin (simvastatin)
  • Metformin (metformin)
  • Lisinopril (lisinopril)
  • Insulin (insulin)
  • Glimepiride (glimepiride)
  • Fish Oil (fish Oil)
  • Calcium Carbonate (calcium Carbonate)
  • D3 (colecalciferol)
and developed a serious reaction and side effect(s): Cough, Dyspnoea, Oxygen Saturation Decreased, Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Definity treatment in female patients, resulting in Cough side effect.
Definity Side Effect Report#9280469
Nausea, Presyncope, Convulsion, Unresponsive To Stimuli, Pulse Absent, Blood Pressure Immeasurable
This report suggests a potential Definity Nausea side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: echocardiogram and used Definity (dosage: 1 Vial Definity Diluted With 8 Ml Normal Saline (3 Ml, Intravenous Bolus)) starting
Apr 17, 2013. After starting Definity the patient began experiencing various side effects, including: Nausea, Presyncope, Convulsion, Unresponsive To Stimuli, Pulse Absent, Blood Pressure ImmeasurableAdditional drugs used concurrently:
  • Beta Blocker
  • Ace Inhibitor
Although Definity demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nausea, may still occur.
Definity Side Effect Report#9190618
Erythema, Throat Tightness, Epistaxis, Unresponsive To Stimuli, Seizure Like Phenomena
This Erythema problem was reported by a physician from US. A 22-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: echocardiogram. On
Mar 06, 2013 this consumer started treatment with Definity (dosage: 1.5 Definity Diluted With 8.5). The following drugs were being taken at the same time:
  • Famotidine (famotidine)
  • Diphenhydramine (diphenhydramine)
  • Lorazepam (lorazepam)
  • B12 (cyanocobalamin)
When using Definity, the patient experienced the following unwanted symptoms/side effects: Erythema, Throat Tightness, Epistaxis, Unresponsive To Stimuli, Seizure Like PhenomenaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Erythema, may become evident only after a product is in use by the general population.
Definity Side Effect Report#9174101
Anaphylactic Shock, Atrial Fibrillation, Renal Failure Acute, Burning Sensation, Eye Movement Disorder, Respiratory Arrest
This Anaphylactic Shock side effect was reported by a physician from US. A 87-year-old female patient (weight:NA) experienced the following symptoms/conditions: echocardiogram.The patient was prescribed Definity (drug dosage: Diluted In 8.5 Ml Normal Saline (2 Ml)), which was initiated on
Feb 19, 2013. Concurrently used drugs:
  • Acetaminophen (paracetamol)
  • Enalapril
  • Gabapentin (gabapentin)
  • Tramadol (tramadol)
  • Nystatin (nystatin)
  • Senna Docusate (docusate, Senna Alexandrina)
  • Diclofenac (diclofenac)
  • Atenolol (atenolol)
.After starting to take Definity the consumer reported adverse symptoms, such as: Anaphylactic Shock, Atrial Fibrillation, Renal Failure Acute, Burning Sensation, Eye Movement Disorder, Respiratory ArrestThese side effects may potentially be related to Definity. The patient was hospitalized.
Definity Side Effect Report#9174079
Feeling Hot, Pulseless Electrical Activity, Dyspnoea, Post Procedural Complication
This is a report of a 70-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: echocardiogram, who was treated with Definity (dosage: 1 Vial Diluted With Normal Saline (2 Ml), start time:
Feb 22, 2013), combined with:
  • Lipitor (atorvastatin Calcium)
  • Lopressor (metoprolol Tartrate)
  • Benadryl(diphenhydramine Hydrochloride)
  • Ativan(lorazepam)
  • Estraderm(estradiol)
  • Zestril(lisinopril)
  • K-dur(potassium Chloride)
  • Zofran(ondansetron)
and developed a serious reaction and side effect(s): Feeling Hot, Pulseless Electrical Activity, Dyspnoea, Post Procedural Complication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Definity treatment in female patients, resulting in Feeling Hot side effect. The patient was hospitalized.


1 of 51 


The appearance of Definity on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

300x250 Start Your Diet Today
These healthy diet meal plans are based on the science of what your body needs to lose fat and maintain a lifetime commitment to health. With bistroMD you will enjoy delicious recipes prepared with the right ingredients so that you can learn how to lose weight the healthy way and also rediscover the enjoyment of eating.

What are common Definity Side Effects for Women?

Women Side EffectsReports
Back Pain 279
Dyspnoea 63
Chest Pain 54
Flushing 45
Urticaria 37
Headache 31
Muscle Spasms 28
Pain In Extremity 27
Nausea 24
Dizziness 23

What are common Definity Side Effects for Men?

Men Side EffectsReports
Back Pain 371
Urticaria 65
Dyspnoea 52
Flushing 43
Headache 40
Pruritus 38
Muscle Spasms 35
Dizziness 34
Hypotension 31
Chest Pain 29

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Definity reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Definity Side Effects

    Did You Have a Definity Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Definity for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Definity Safety Alerts, Active Ingredients, Usage Information

    NDC11994-011
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDefinity
    Nameperflutren
    Dosage FormINJECTION, SUSPENSION
    RouteINTRAVENOUS
    On market since20010731
    LabelerLantheus Medical Imaging, Inc.
    Active Ingredient(s)PERFLUTREN
    Strength(s)6.52
    Unit(s)mg/mL
    Pharma ClassContrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA]

    More About Definity

    Side Effects reported to FDA: 1251

    Definity safety alerts: 2008 2007

    Reported deaths: 42

    Reported hospitalizations: 140

    Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)

    Audience: Radiological healthcare professionals, cardiologists, hospital risk managers 

    [Posted 07/17/2008] FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.These changes reflect conclusions of FDA reviews of information received following the addition of new Contraindications and Warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.

    [July 17, 2008 - Information for Healthcare Professionals - FDA] 
    [June 2008 - Dear Healthcare Professional Letter - GE] 
    [May 2008 - Dear Healthcare Professional Letter - Lantheus Medical Imaging]

    Latest Definity clinical trials