Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications and Warnings
|
Aptivus (tipranavir) Capsules
(click product name to read prescribing information)
See MedWatch Safety Alert posted 6/30/2006 for additional
information on Aptivus and intracranial hemorrhage. |
BOXED WARNING WARNINGS
PRECAUTIONS
- Information for Patients
- Drug Interactions
- Table 9: Established and Other Potentially
Significant Drug Interactions.....
- Antidepressants
- Inhaled Nasal Steroids
- PDE5 Inhibitors
ADVERSE REACTIONS
PATIENT PACKAGE INSERT |
BOXED WARNING
Aptivus co-administered with 200 mg Ritonavir
has been associated with reports of both fatal and non-fatal
intracranial hemorrhage.
WARNINGS/Intracranial Hemorrhage
Aptivus, co-administered with 200 mg of
ritonavir, has been associated with reports of both fatal and
non-fatal intracranial hemorrhage (ICH). Many of these patients
had other medical conditions or were receiving concomitant
medications that may have caused or contributed to these events.
No pattern of abnormal coagulation parameters has been observed
in patients in general, or preceding the development of ICH.
Therefore, routine measurement of coagulation parameters is not
currently indicated in the management of patients on Aptivus.
WARNINGS/Platelet Aggregation Inhibition
In in vitro experiments,
tipranavir was observed to inhibit human platelet aggregation at
levels consistent with exposures observed in patients receiving
Aptivus/ritonavir.
Aptivus/ritonavir should be used with caution
in patients who may be at risk of increased bleeding from
trauma, surgery or other medical conditions, or who are
receiving medications known to increase the risk of bleeding
such as antiplatelet agents or anticoagulants.
WARNINGS/Drug Interactions
A drug interaction study in healthy subjects has
shown that ritonavir significantly increases plasma fluticasone
propionate exposures, resulting in significantly decreased serum
cortisol concentrations. Concomitant use of Aptivus/ritonavir
and fluticasone propionate may produce the same effects.....
Particular caution should be used when
prescribing phosphodiesterase (PDE5) inhibitors for erectile
dysfunction (e.g., sildefafil, tadalafil, or vardenafil) in
patients receiving protease inhibitors, including Aptivus..... |
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Dexedrine (dextroamphetamine sulfate) Spansule
Sustained-Release Capsules and Tablets
(click product name to read prescribing information)
See MedWatch Safety Alert posted 8/21/2006 for additional
information on Dexedrine and new safety information on cardiac
and psychiatric events.
|
BOXED WARNING
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients
Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
|
BOXED WARNING
Misuse of amphetamines may cause sudden death and serious
cardiovascular adverse events.
WARNINGS
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events.
|
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|
Prevacid NapraPAC (lansoprazole delayed-release capsules and naproxen
tablets kit)
(click product name to read prescribing information)
See MedWatch 6/15/2005 Safety Alert for additional information
on COX-2 Selective and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) labeling.
|
BOXED WARNING
(new)
-
Cardiovascular Risk
- Gastrointestinal Risk
CONTRAINDICATIONS
WARNINGS
- Cardiovascular Effects
- Cardiovascular Thrombotic Events
- Hypertension
- Congestive Heart Failure and Edema
- Gastrointestinal Effects - Risk of Ulceration, Bleeding,
and Perforation
- Renal Effects
- Advanced Renal Disease
- Anaphylactoid Reactions
- Skin Reactions
- Pregnancy
PRECAUTIONS
- General
- Naprosyn
- Hepatic Effects
- Hematological Effects
- Aspirin-Sensitive Asthma
- Information for Patients
- Laboratory Tests
- Drug Interactions
- Naprosyn
- ACE-inhibitors
- Aspirin
- Diuretics
- Lithium
- Methotrexate
- Warfarin
- Pregnancy
- Teratogenic Effects. Pregnancy Category C
- Nonteratogenic Effects
- Labor and Delivery
- Nursing Mothers
- Pediatric Use
- Geriatric Use
ADVERSE REACTIONS
MEDICATION GUIDE
|
BOXED WARNING/Cardiovascular Risk
NSAIDs may cause an increased risk of serious
cardiovascular thrombotic events, myocardial infarction, and
stroke, which can be fatal. This risk may increase with duration
of use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk.
Prevacid NapraPAC is contraindicated for the
treatment of peri-operative pain in the setting of coronary
artery bypass graft (CABG) surgery.
BOXED WARNING/Gastrointestinal Risk
NSAIDs cause an increased risk of serious
gastrointestinal adverse events including bleeding and
perforation of the stomach and intestines, which can be fatal.
These events can occur at any time during use and without
warning symptoms. Patients with a history of gastric and/or
duodenal ulcers (especially patients with a history of bleeding
or perforation) and geriatric patients are at greater risk for
serious gastrointestinal events.
CONTRAINDICATIONS
Prevacid NapraPAC is contraindicated in patients
who have experienced aspirin or NSAID-related asthma, urticaria,
or allergic-type reactions. Severe, rarely fatal, anaphylactic
reactions to NSAIDs have been reported in such patients.
Prevacid NapraPAC is contraindicated for the
treatment of peri-operative pain in the setting of coronary
artery bypass graft (CABG) surgery.
WARNINGS
See highlighted WARNINGS section for revised labeling.
|
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications
and Warnings |
Nafcillin Injection, USP for Intravenous Use Only
(click product name to read prescribing information)
|
SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce
the development of drug-resistant bacteria. CONTRAINDICATIONS
PRECAUTIONS
- General
- Prescribing Nafcillin Injection, USP in the
absence of a proven or strongly suspected bacterial infection
or a prophylactic indication is unlikely to provide benefit to
the patient and increases the risk of the development of
drug-resistant bacteria.
- Information for Patients
- Patients should be counseled that
antibacterial drugs including Nafcillin Injection, USP should
only be used to treat bacterial infections.....
|
CONTRAINDICATIONS
Solutions containing dextrose may be
contraindicated in patients with known allergy to corn or corn
products.
|
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Prevpac (lansoprazole 30mg capsules/amoxicillin
500mg capsules/ clarithromycin 500mg tablets, USP)
Please contact TAP Pharmaceutical Products, Inc. at
1-800-622-2011 for
prescribing information. |
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
- Drug Interactions
- Clarithromycin
- CYP3A Drug Interactions
- Ergotamine/ dihydroergotamine
ADVERSE REACTIONS
-
Postmarketing
- Clarithromycin
- Post-marketing Experience
- Interstitial Nephritis
- There have been post-marketing reports of
colchicine toxicity with concomitant use of clarithromycin
and colchicine, especially in the elderly, some of which
occurred in patients with renal insufficiency. Deaths have
been reported in some such patients.
MEDICATION GUIDE |
CONTRAINDICATIONS
Concomitant administration of Prevpac with
cisapride, pimozide, astemizole, terfenadine, ergotamine or
dihydroergotamine is contraindicated.
WARNINGS/Clarithromycin
There have been post-marketing reports of
colchicine toxicity with concomitant use of clarithromycin and
colchicine, especially in the elderly, some of which occurred in
patients with renal insufficiency. Deaths have been reported in
some such patients.
PRECAUTIONS/Drug Interactions
Clarithromycin Colchicine is a substrate for both CYP3A and
the efflux transporter, P-glycoprotein (Pgp). Clarithromycin
and other macrolides are known to inhibit CYP3A and Pgp.
When clarithromycin and colchicine are administered
together, inhibition of Pgp and/or CYP3A by clarithromycin
may lead to increased exposure to colchicine. Patients
should be monitored for clinical symptoms of colchicine
toxicity.
CYP3A Drug Interactions: Ergotamine/dihydroergotamine
Post-marketing reports indicate that coadministration of
clarithromycin with ergotamine or dihydroergotamine has been
associated in some patients with acute ergot toxicity
characterized by vasospasm and ischemia of the
extremities and other tissues including the central nervous
system. Concomitant administration of clarithromycin with
ergotamine or dihydroergotamine is contraindicated. |
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications and Warnings |
Cordarone (amiodarone hydrochloride) Intravenous
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
|
Cordarone-induced hyperthyroidism may result in
thyrotoxicosis and/or the possibility of arrhythmia breakthrough
or aggravation. There have been reports of death associated with
amiodarone-induced thyrotoxicosis. If any new signs of arrhythmia
appear, the possibility of hyperthyroidism should be considered. |
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Cordarone (amiodarone hydrochloride) Tablets
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
MEDICATION GUIDE |
Cordarone-induced hyperthyroidism may result in
thyrotoxicosis and/or the possibility of arrhythmia breakthrough
or aggravation. There have been reports of death associated with
amiodarone-induced thyrotoxicosis. If any new signs of arrhythmia
appear, the possibility of hyperthyroidism should be considered. |
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Coreg (carvedilol) Tablets
(click product name to read prescribing information) |
WARNINGS
- Diabetes and Hypoglycemia
PRECAUTIONS
- Effects on Glycemic Control in Type 2 Diabetic Patients
- .....In a study designed to examine the
effects of carvedilol on glycemic control in a population with
mild-to-moderate hypertension and well-controlled type 2
diabetes mellitus, carvedilol had no adverse effect on
glycemic control, based on HbA1c measurements.
|
In general, β-blockers
may mask some of the manifestations of hypoglycemia,
particularly tachycardia. Nonselective β-blockers
may potentiate insulin-induced hypoglycemia and delay recovery
of serum glucose levels. Patients subject to spontaneous
hypoglycemia, or diabetic patients receiving insulin or oral
hypoglycemic agents, should be cautioned about these
possibilities. In congestive heart failure patients, there is
a risk of worsening hyperglycemia. |
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Epzicom (abacavir sulfate and lamivudine) Tablets
(click product name to read prescribing information) |
WARNINGS
- Use With Interferon- and
Ribavirin-Based Regimens
PRECAUTIONS
- Immune Reconstitution Syndrome
MEDICATION GUIDE |
In vitro studies have shown ribavirin can reduce
the phosphorylation of pyrimidine nucleoside analogues such as
lamivudine, a component of Epzicom. Although no evidence of a
pharmacokinetic or pharmacodynamic interaction (e.g., loss of HIV/HCV
virologic suppression) was seen when ribavirin was coadministered
with lamivudine in HIV/HCV co-infected patients, hepatic
decompensation (some fatal) has occurred in HIV/HCV co-infected
patients receiving combination antiretroviral therapy for HIV and
interferon alfa with or without ribavirin. Patients
receiving interferon alfa with or without ribavirin and Epzicom
should be closely monitored for treatment-associated toxicities,
especially hepatic decompensation. Discontinuation of Epzicom
should be considered as medically appropriate. Dose reduction or
discontinuation of interferon alfa, ribavirin, or both should also
be considered if worsening clinical toxicities are observed,
including hepatic decompensation (e.g., Childs Pugh >6)..... |
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Focalin (dexmethylphenidate hydrochloride
tablets)
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
PATIENT
PACKAGE INSERT |
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events. |
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Focalin XR (dexmethylphenidate hydrochloride)
Extended-Release Capsules
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
PATIENT
PACKAGE INSERT |
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events. |
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Forane (isoflurane, USP) Liquid for Inhalation
(click product name to read prescribing information) |
WARNINGS
PRECAUTIONS
- General
- As with other halogenated anesthetic agents, Forane (isoflurane,
USP) may cause sensitivity hepatitis in patients who have
been sensitized by previous exposure to halogenated
anesthetics.
ADVERSE REACTIONS
-
There have been rare post-marketing reports of
hepatic failure and hepatic necrosis associated with the use of
potent volatile anesthetic agents, including Forane (isoflurane,
USP). Due to the spontaneous nature of these reports, the actual
incidence and relationship of Forane (isoflurane, USP) to these
events cannot be established with certainty.
|
WARNINGS/Perioperative
Hyperkalemia
Use of inhaled anesthetic agents has been associated with rare
increases in serum potassium levels that have resulted in cardiac
arrhythmias and death in pediatric patients during the
postoperative period. Patients with latent as well as overt
neuromuscular disease, particularly Duchenne muscular dystrophy,
appear to be most vulnerable. Concomitant use of succinylcholine
has been associated with most, but not all, of these cases. These
patients also experienced significant elevations in serum
creatinine kinase levels and, in some cases, changes in urine
consistent with myoglobinuria. Despite the similarity in
presentation to malignant hyperthermia, none of these patients
exhibited signs or symptoms of muscle rigidity or hypermetabolic
state. Early and aggressive intervention to treat the hyperkalemia
and resistant arrhythmias is recommended, as is subsequent
evaluation for latent neuromuscular disease.
WARNINGS/Malignant Hyperthermia
In susceptible individuals, isoflurane anesthesia
may trigger a skeletal muscle hypermetabolic state leading to high
oxygen demand and the clinical syndrome known as malignant
hyperthermia. The syndrome includes nonspecific features such as
muscle rigidity, tachycardia, tachypnea, cyanosis, arrhythmias,
and unstable blood pressure. (It should also be noted that many of
these nonspecific signs may appear with light anesthesia, acute
hypoxia, etc.)
Treatment includes discontinuance of triggering
agents (e.g., isoflurane), administration of intravenous
dantrolene sodium, and application of supportive therapy. Such
therapy includes vigorous efforts to restore body temperature to
normal, respiratory and circulatory support as indicated, and
management of electrolyte-fluid-acid-base derangements. (Consult
prescribing information for dantrolene sodium intravenous for
additional information on patient management). Renal failure may
appear later, and urine flow should be sustained if possible. |
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Keppra (levetiracetam) Tablets and Oral Solution
(click product name to read prescribing information) |
WARNINGS
- Neuropsychiatric Adverse Events
PRECAUTIONS
- Hematologic Abnormalities
- Juvenile Myoclonic Epilepsy
ADVERSE REACTIONS
- Myoclonic Seizures
- Table 10: Incidence (%) Of Treatment-Emergent
Adverse Events in a Placebo-Controlled, Add-On Study In
Patients 12 Years Of Age And Older With Myoclonic Seizures
- Discontinuation or Dose Reduction in
Well-Controlled Clinical Studies
- Myoclonic Seizures
- Table 13: Adverse Events that Resulted in
Discontinuation or Dose Reduction.....
- Post-marketing Experience
- Abnormal Liver Function Test
- Hepatitis
- Weight Loss
PATIENT PACKAGE INSERT |
During clinical development, the number of
patients with myoclonic seizures exposed to Keppra was
considerably smaller than the number with partial seizures.
Therefore, under-reporting of certain adverse events was more
likely to occur in the myoclonic seizure population. In adult and
adolescent patients experiencing myoclonic seizures, Keppra is
associated with somnolence and behavioral abnormalities. It is
expected that the events seen in partial seizure patients would
occur in patients with JME..... |
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Metadate CD (methylphenidate hydrochloride, USP)
Extended-Release Capsules
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
PATIENT PACKAGE INSERT |
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events. |
![clear pixel](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
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Methylin (methylphenidate
hydrochloride chewable tablets)
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
|
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events. |
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|
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Methylin (methylphenidate hydrochloride
oral solution)
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
|
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events. |
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Naropin (ropivacaine HCl) Injection
(click product name to read prescribing information) |
WARNINGS
MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES
- Should cardiac arrest occur, prolonged
resuscitative efforts may be required to improve the probability
of a successful outcome.
|
.....There have been rare reports of cardiac arrest
during the use of Naropin for epidural anesthesia or peripheral
nerve blockade, the majority of which occurred after unintentional
accidental intravascular administration in elderly patients and in
patients with concomitant heart disease. In some instances,
resuscitation has been difficult. Should cardiac arrest occur,
prolonged resuscitative efforts may be required to improve the
probability of a successful outcome. |
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Paxil (paroxetine hydrochloride) Tablets and Oral
Suspension
(click product name to read prescribing information)
See MedWatch Safety Alert posted on 5/12/2006 for
additional details on WARNINGS and Clinical Worsening and Suicide
Risk.
See MedWatch Safety Alert posted on 7/19/2006 for
additional details on Triptans,
Selective Serotonin Reuptake
Inhibitors (SSRIs),
Selective Serotonin/ Norepinephrine Reuptake Inhibitors
(SNRIs), and Serotonin
Syndrome.
See MedWatch Safety Alert posted on 7/19/2006 for
additional details on SSRIs and Treatment Challenges of Depression
in Pregnancy. |
WARNINGS
- Clinical Worsening and Suicide Risk
- Serotonin Syndrome
- Usage in Pregnancy
PRECAUTIONS
- Discontinuation of Treatment with Paxil
- Information for Patients
- Drug Interactions
- Serotonergic Drugs
- Triptans
- Fosamprenavir/Ritonavir
- Co-administration of fosamprenavir/ritonavir
with paroxetine significantly decreased plasma levels of
paroxetine. Any dose adjustment should be guided by clinical
effect (tolerability and efficacy).
ADVERSE REACTIONS
-
Hallucinations
- In pooled clinical trials of immediate-release
paroxetine hydrochloride, hallucinations were observed in 22
of 9,089 receiving drug and 4 of 3,187 patients receiving
placebo.
|
WARNINGS/Clinical Worsening and Suicide Risk
.....In addition, patients with a history of suicidal
behavior or thoughts, those patients exhibiting a significant
degree of suicidal ideation prior to commencement of treatment,
and young adults, are at an increased risk of suicidal thoughts or
suicide attempts, and should receive careful monitoring during
treatment.
WARNINGS/Serotonin Syndrome
The development of a potentially life-threatening
serotonin syndrome may occur with use of Paxil, particularly with
concomitant use of serotonergic drugs (including triptans) and
with drugs which impair metabolism of serotonin (including MAOIs).....
WARNINGS/Usage in Pregnancy: Nonteratogenic
Effects
Infants exposed to SSRIs in late pregnancy may
have an increased risk for persistent pulmonary hypertension of
the newborn (PPHN). PPHN occurs in 1 – 2 per 1,000 live births in
the general population and is associated with substantial neonatal
morbidity and mortality.....
.....Physicians should note that in a prospective
longitudinal study of 201 women with a history of major depression
who were euthymic at the beginning of pregnancy, women who
discontinued antidepressant medication during pregnancy were more
likely to experience a relapse of major depression than women who
continued antidepressant medication. |
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|
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|
Paxil CR (paroxetine hydrochloride)
Controlled-Release Tablets
(click product name to read prescribing information)
See MedWatch Safety Alert posted on 5/12/2006 for
additional details on WARNINGS and Clinical Worsening and Suicide
Risk.
See MedWatch Safety Alert posted on 7/19/2006 for
additional details on Triptans,
Selective Serotonin Reuptake
Inhibitors (SSRIs),
Selective Serotonin/ Norepinephrine Reuptake Inhibitors
(SNRIs), and Serotonin
Syndrome.
See MedWatch Safety Alert posted on 7/19/2006 for
additional details on SSRIs and Treatment Challenges of Depression
in Pregnancy.
|
WARNINGS
PRECAUTIONS
- Discontinuation of Treatment with Paxil CR
- Information for Patients
- Drug Interactions
- Serotonergic Drugs
- Triptans
- Fosamprenavir/Ritonavir
- Co-administration of fosamprenavir/ritonavir
with paroxetine significantly decreased plasma levels of
paroxetine. Any dose adjustment should be guided by clinical
effect (tolerability and efficacy).
ADVERSE REACTIONS
- Hallucinations
- In pooled clinical trials of immediate-release
paroxetine hydrochloride, hallucinations were observed in 22
of 9,089 receiving drug and 4 of 3,187 patients receiving
placebo.
|
WARNINGS/Clinical Worsening and Suicide Risk
.....In addition, patients with a history of suicidal
behavior or thoughts, those patients exhibiting a significant
degree of suicidal ideation prior to commencement of treatment,
and young adults, are at an increased risk of suicidal thoughts or
suicide attempts, and should receive careful monitoring during
treatment.
WARNINGS/Serotonin Syndrome
The development of a potentially life-threatening
serotonin syndrome may occur with use of Paxil CR, particularly
with concomitant use of serotonergic drugs (including triptans)
and with drugs which impair metabolism of serotonin (including
MAOIs).....
WARNINGS/Usage in Pregnancy: Nonteratogenic
Effects
Infants exposed to SSRIs in late pregnancy may
have an increased risk for persistent pulmonary hypertension of
the newborn (PPHN). PPHN occurs in 1 – 2 per 1,000 live births in
the general population and is associated with substantial neonatal
morbidity and mortality.....
.....Physicians should note that in a prospective
longitudinal study of 201 women with a history of major depression
who were euthymic at the beginning of pregnancy, women who
discontinued antidepressant medication during pregnancy were more
likely to experience a relapse of major depression than women who
continued antidepressant medication. |
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|
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|
Plavix (clopidogrel bisulfate tablets)
(click product name to read prescribing information)
This supplemental new drug application provides
for revisions to the WARNINGS,
PRECAUTIONS and ADVERSE REACTIONS sections of the
package insert. |
WARNINGS
- Thrombotic thrombocytopenic purpura (TTP)
PRECAUTIONS
ADVERSE REACTIONS
- Post-marketing Experience
|
TTP has been reported rarely following use of
Plavix, sometimes after a short exposure (< 2 weeks). TTP is a
serious condition that can be fatal and requires urgent treatment
including plasmapheresis (plasma exchange). It is characterized by
thrombocytopenia, microangiopathic hemolytic anemia (schistocytes
[fragmented RBCs] seen on peripheral smear), neurological
findings, renal dysfunction, and fever. |
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|
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|
Rebetol (ribavirin, USP) Capsules and Oral Solution
(click product name to read prescribing information) |
WARNINGS
- Dental and Periodontal Disorders
|
Dental and periodontal disorders have been
reported in patients receiving ribavirin and interferon or peginterferon combination therapy. In addition, dry mouth could have
a damaging effect on teeth and mucous membranes of the mouth
during long-term treatment with the combination of Rebetol and
interferon alfa-2b or pegylated interferon alfa-2b. Patients
should brush their teeth thoroughly twice daily and have regular
dental examinations. In addition, some patients may experience
vomiting. If this reaction occurs, they should be advised to rinse
out their mouth thoroughly afterwards. |
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|
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Ritalin LA (methylphenidate hydrochloride)
Extended-Release Capsules
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
PATIENT PACKAGE INSERT |
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events. |
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|
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|
Ritalin (methylphenidate hydrochloride tablets,
USP)
Ritalin SR (methylphenidate hydrochloride, USP)
Sustained-Release Tablets
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden
Death and Pre-Existing Structural Cardiac Abnormalities or
Other Serious Heart Problems
- Children and Adolescents
- Adults
- Hypertension and Other Cardiovascular Conditions
- Assessing Cardiovascular Status in Patients Being Treated with
Stimulant Medications
- Psychiatric Adverse Events
- Pre-Existing Psychosis
- Bipolar
Illness
- Emergence of New Psychotic or Manic Symptoms
- Aggression
- Long-Term Suppression of Growth
- Seizures
- Visual Disturbances
|
See highlighted prescribing information for new WARNINGS
information as a result of a class labeling initiative
for all central nervous system (CNS) stimulant medications that
include safety language for cardiac and psychiatric events. |
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|
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|
Roferon-A
(interferon alfa-2a, recombinant)
Please contact Hoffman- LaRoche, Inc. at 1-973-235-5000 for
prescribing information. |
WARNINGS
ADVERSE REACTIONS
- Post-marketing
- Metabolic and Nutritional
- Hypertriglyceridemia/ Hyperlipidemia
|
Infections
While fever may be associated with the flu-like syndrome reported
commonly during interferon therapy, other causes of high or
persistent fever must be ruled out, particularly in patients with
neutropenia. Serious and severe infections (bacterial, viral,
fungal), some fatal, have been reported during treatment with
alpha interferons including Roferon-A. Appropriate anti-infective
therapy should be started immediately and discontinuation of
therapy should be considered.
Pancreatitis
Pancreatitis has been observed in patients
receiving alpha interferon treatment, including those who
developed marked triglyceride elevations. In some cases,
fatalities have been observed. Although a causal
relationship to Roferon has not been established, marked
triglyceride elevation is a risk factor for development of
pancreatitis. Roferon should be suspended if symptoms or signs
suggestive of pancreatitis are observed. In patients diagnosed
with pancreatitis, discontinuation of therapy with Roferon
should be considered. |
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Suprane (desflurane, USP) Liquid for Inhalation
(click product name to read prescribing information) |
WARNINGS
- Perioperative Hyperkalemia
- Malignant Hyperthermia
PRECAUTIONS
-
Initial Section
- As with other halogenated anesthetic agents,
Suprane (desflurane, USP) may cause sensitivity hepatitis in
patients who have been sensitized by previous exposure to
halogenated anesthetics.
ADVERSE REACTIONS
- Adverse reactions reported only from
post-marketing experience or in the literature, not seen in
clinical trials, are considered rare and are italicized.
- There have been rare post-marketing reports of
hepatic failure and hepatic necrosis associated with the use of
potent volatile anesthetic agents, including Suprane (desflurane,
USP). Due to the spontaneous nature of these reports, the actual
incidence and relationship of Suprane (desflurane, USP) to these
events cannot be established with certainty.
|
WARNINGS/Perioperative Hyperkalemia
Use of inhaled anesthetic agents has been
associated with rare increases in serum potassium levels that have
resulted in cardiac arrhythmias and death in pediatric patients
during the postoperative period. Patients with latent as well as
overt neuromuscular disease, particularly Duchenne muscular
dystrophy, appear to be most vulnerable. Concomitant use of
succinylcholine has been associated with most, but not all, of
these cases. These patients also experienced significant
elevations in serum creatinine kinase levels and, in some cases,
changes in urine consistent with myoglobinuria. Despite the
similarity in presentation to malignant hyperthermia, none of
these patients exhibited signs or symptoms of muscle rigidity or
hypermetabolic state. Early and aggressive intervention to treat
the hyperkalemia and resistant arrhythmias is recommended, as is
subsequent evaluation for latent neuromuscular disease.
WARNINGS/Malignant
Hyperthermia
In susceptible individuals, potent inhalation
anesthetic agents may trigger a skeletal muscle hypermetabolic
state leading to high oxygen demand and the clinical syndrome
known as malignant hyperthermia. In genetically susceptible pigs,
desflurane induced malignant hyperthermia. The clinical syndrome
is signalled by hypercapnia, and may include muscle rigidity,
tachycardia, tachypnea, cyanosis, arrhythmias, and/or unstable
blood pressure. Some of these nonspecific signs may also appear
during light anesthesia: acute hypoxia, hypercapnia, and
hypovolemia..... |
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Trizivir (abacavir sulfate/ lamivudine/zidovudine)
Tablets
(click product name to read prescribing information)
|
WARNINGS
- Use with Interferon- and
Ribavirin-Based Regimens
- Other
MEDICATION GUIDE |
WARNINGS/Use with
Interferon- and Ribavirin-Based Regimens
In vitro studies have shown ribavirin can reduce the
phosphorylation of pyrimidine nucleoside analogues such as
lamivudine and zidovudine, components of Trizivir. Although no
evidence of a pharmacokinetic or pharmacodynamic interaction
(e.g., loss of HIV/HCV virologic suppression) was seen when
ribavirin was coadministered with lamivudine or zidovudine in HIV/HCV
co-infected patients, hepatic decompensation (some fatal)
has occurred in HIV/HCV co-infected patients receiving combination
antiretroviral therapy for HIV and interferon alfa with or without
ribavirin. Patients receiving interferon alfa with or
without ribavirin and Trizivir should be closely monitored for
treatment-associated toxicities, especially hepatic decompensation,
neutropenia, and anemia. Discontinuation of Trizivir should be
considered as medically appropriate. Dose reduction or
discontinuation of interferon alfa, ribavirin, or both should also
be considered if worsening clinical toxicities are observed,
including hepatic decompensation (e.g., Childs Pugh >6).....
WARNINGS/Other
Trizivir contains fixed doses of 3 nucleoside
analogues..... |
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Videx (didanosine) Chewable/Dispersible
Buffered Tablets
Videx (didanosine) Pediatric Powder for
Oral Solution
(click product name to read prescribing information) |
WARNINGS
- Hepatic Impairment and Toxicity
PRECAUTIONS
- Peripheral Neuropathy
- .....Peripheral neuropathy, which was severe
in some cases, has been reported in HIV-infected patients
receiving hydroxyurea in combination with antiretroviral
agents, including didanosine, with or without stavudine.
- Immune Reconstitution Syndrome
- Drug Interactions
- Table 7: Established Drug Interactions with
Videx
- Tenofovir Disoproxil Fumarate
- Nucleoside/nucleotide Analogues
ADVERSE REACTIONS
-
Initial Section
- Hepatotoxicity and Severe Peripheral
Neuropathy
|
It is unknown if hepatic impairment significantly
affects didanosine pharmacokinetics. Therefore, these patients
should be monitored closely for evidence of didanosine toxicity.
The safety and efficacy of Videx have not been established in
HIV-infected patients with significant underlying liver disease.
During combination antiretroviral therapy, patients with
preexisting liver dysfunction, including chronic active hepatitis,
have an increased frequency of liver function abnormalities,
including severe and potentially fatal hepatic adverse events, and
should be monitored according to standard practice. If there is
evidence of worsening liver disease in such patients, interruption
or discontinuation of treatment must be considered.
Hepatotoxicity and hepatic failure resulting in
death were reported during post-marketing surveillance in
HIV-infected patients treated with hydroxyurea and other
antiretroviral agents. Fatal hepatic events were reported most
often in patients treated with the combination of hydroxyurea,
didanosine, and stavudine. This combination should be avoided. |
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Videx EC (didanosine)
Delayed-Release Capsules [Enteric-Coated Beadlets]
(click product name to read prescribing information) |
WARNINGS
- Hepatic Impairment and Toxicity
PRECAUTIONS
- Peripheral Neuropathy
- .....Peripheral neuropathy, which was severe
in some cases, has been reported in HIV-infected patients
receiving hydroxyurea in combination with antiretroviral
agents, including didanosine, with or without stavudine.
- Immune Reconstitution Syndrome
- Drug Interactions
- Table 8: Established Drug Interactions with Videx
EC.....
- Tenofovir Disoproxil Fumarate
- Nucleoside/nucleotide Analogues
ADVERSE REACTIONS
-
Initial Section
- Hepatotoxicity and Severe Peripheral
Neuropathy
|
It is unknown if hepatic impairment significantly
affects didanosine pharmacokinetics. Therefore, these patients
should be monitored closely for evidence of didanosine toxicity.
The safety and efficacy of Videx EC have not been established in
HIV-infected patients with significant underlying liver disease.
During combination antiretroviral therapy, patients with
preexisting liver dysfunction, including chronic active hepatitis,
have an increased frequency of liver function abnormalities,
including severe and potentially fatal hepatic adverse events, and
should be monitored according to standard practice. If there is
evidence of worsening liver disease in such patients, interruption
or discontinuation of treatment must be considered.
Hepatotoxicity and hepatic failure resulting in
death were reported during post-marketing surveillance in
HIV-infected patients treated with hydroxyurea and other
antiretroviral agents. Fatal hepatic events were reported most
often in patients treated with the combination of hydroxyurea,
didanosine, and stavudine. This combination should be avoided. |
MedWatch
Home | Safety Information | Submit
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Back to Summary Page
Brand
(Generic) Name |
Sections Modified |
Actonel (risedronate sodium tablets)
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
- Table 6: Adverse Events Occurring in ≥ 2% of Patients of
Either Treatment Group.....
- Osteoporosis Prevention
- Men with Osteoporosis
PATIENT PACKAGE INSERT |
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Actoplus Met (pioglitazone hydrochloride
and metformin hydrochloride tablets)
(click product name to read prescribing information) |
PRECAUTIONS
- General
- Pioglitazone Hydrochloride
ADVERSE REACTIONS
- Post-marketing reports of new onset or worsening diabetic
macular edema with decreased visual acuity have also been
received.
|
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|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Actos (pioglitazone hydrochloride) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
- Post-marketing reports of new onset or worsening diabetic
macular edema with decreased visual acuity have also been
received.
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
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Atacand (candesartan cilexetil) Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
|
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|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Atacand HCT (candesartan cilexetil and hydrochlorothiazide) Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Boniva (ibandronate sodium) Injection
(click product name to read prescribing information) |
PRECAUTIONS
PATIENT PACKAGE INSERT |
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Cozaar (losartan potassium tablets)
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
- Post-marketing Experience
- Nervous System Disorders
- Skin
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Diprolene (augmented betamethasone dipropionate)
AF Cream, 0.05%
(click product name to read prescribing
information) |
PRECAUTIONS
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Diprolene (augmented betamethasone dipropionate)
Lotion, 0.05%
(click product name to read prescribing
information) |
PRECAUTIONS
|
Diprolene (augmented betamethasone dipropionate)
Ointment, 0.05%
(click product name to read prescribing
information)
|
PRECAUTIONS
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
E.E.S. (erythromycin ethylsuccinate)
(click product name to read prescribing information) |
PRECAUTIONS
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Hyzaar (losartan potassium/hydrochlorothiazide
tablets)
(click product name to read prescribing information
|
PRECAUTIONS
ADVERSE REACTIONS
- Post-marketing Experience
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
Lexiva (fosamprenavir calcium) Tablets
(click product name to read prescribing information
|
PRECAUTIONS
- Drug Interactions
- Table 13: Established and Other
Potentially Significant Drug Interactions.....
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
|
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif) |
OptiMARK (gadoversetamide injection) for
Intravenous Injection Only
(click product name to read prescribing information)
|
PRECAUTIONS
- Laboratory Test Interactions
- Interference by OptiMARK Injection in the
measurement of serum iron, copper and zinc has been observed.
OptiMARK Injection causes interference in the measurement of
serum calcium using the ortho-cresophthalin complexone (OCP)
colorimetric method.....
|
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PCE Dispertab Tablets (erythromycin
particles in tablets)
(click product name to read prescribing information) |
PRECAUTIONS
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Plavix (clopidogrel bisulfate tablets)
(click product name to read prescribing information)
This supplemental new drug application provides
for the following new use of Plavix (clopidogrel bisulfate) 75 mg
tablets: For patients with ST-segment elevation acute
myocardial infarction, Plavix has been shown to reduce the rate of
death from any cause and the rate of a combined endpoint of death,
re-infarction or stroke. This benefit is not known to pertain to
patients who receive primary angioplasty.
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PRECAUTIONS
- Drug Interactions
- Thrombolytics
- Oral Anticoagulants
- Geriatric Use
ADVERSE REACTIONS
- Initial Paragraph
- In CLARITY, the incidence of major bleeding
(defined as intracranial bleeding or bleeding associated with
a fall in hemoglobin > 5 g/dL) was similar between groups
(1.3% versus 1.1% in the Plavix + aspirin.....
- The overall rate of noncerebral major bleeding
or cerebral bleeding in COMMIT was low.....
- Table 6: Number (%) of Patients with Bleeding
Events in COMMIT
- Table 7: Adverse Events Occurring in
≥2.5% of Plavix Patients in CAPRIE
- Gastrointestinal System Disorders
- No additional clinically relevant events to
those observed in CAPRIE with a frequency
≥ 2.5%, have been reported
during the CURE and CLARITY controlled studies. COMMIT
collected only limited safety data.
- Gastrointestinal System Disorders
- Peptic, gastric or duodenal ulcer
- Gastritis
- White Cell and Reticuloendothelial System
Disorders
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Remicade (infliximab) for IV Injection
(click product name to read prescribing information) |
PRECAUTIONS
- Nursing Mothers
- .....Women should not breast-feed their infants while
taking Remicade.....
ADVERSE REACTIONS
- Initial Section
- Immunogenicity
- Other Adverse Reactions
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Ultram ER (tramadol hydrochloride)
Extended-Release Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Information for Patients
- Patients should be informed that Ultram
ER is for oral use only and should be swallowed whole.
The tablets should not be chewed, crushed, or split.
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Ziagen (abacavir sulfate) Tablets and Oral
Solution
(click product name to read prescribing information) |
PRECAUTIONS
- Immune Reconstitution Syndrome
- Information for Patients
- Ziagen should not be coadministered with
Epzicom or Trizivir
ADVERSE REACTIONS
MEDICATION GUIDE |
![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
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Zofran (ondansetron
hydrochloride) Injection
Zofran (ondansetron
hydrochloride) Injection Premixed
(click product name to read prescribing information)
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PRECAUTIONS
- General
- .....Rarely and predominantly with
intravenous ondansetron, transient ECG changes including
QT interval prolongation have been reported.
ADVERSE REACTIONS
- Observed During Clinical Practice
- Cardiovascular
- Eye Disorders
- .....These cases of transient
blindness were reported to resolve within a few
minutes up to 48 hours.
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Zofran
(ondansetron hydrochloride) Tablets and Oral
Solution
Zofran ODT (ondansetron hydrochloride) Orally
Disintegrating Tablets
(click product name to read prescribing information)
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PRECAUTIONS
- General
- .....Rarely and predominantly with intravenous
ondansetron, transient ECG changes including QT interval
prolongation have been reported.
ADVERSE REACTIONS
- Observed During Clinical Practice
- Cardiovascular
- Rarely and predominantly with
intravenous ondansetron, transient ECG changes including
QT interval prolongation have been reported.
- Special Senses
- Eye Disorders
- .....These cases of transient
blindness were reported to resolve within a few
minutes up to 48 hours.
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![](https://webarchive.library.unt.edu/eot2008/20090118022542im_/http://www.fda.gov/medwatch/IMAGES/dot_clear.gif)
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Zyprexa (olanzapine tablets)
Zyprexa Zydis (olanzapine orally disintegrating
tablets)
Zyprexa IntraMuscular (olanzapine for injection)
(click product name to read prescribing information)
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PRECAUTIONS
- General
- Hemodynamic Effects
- Hypoventilation
- Caution is necessary in patients who receive
treatment with other drugs having effects that can induce
hypotension, bradycardia, respiratory or central nervous
system depression.....
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