Brand (Generic) Name
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Sections Modified |
Summary of Changes to Contraindications
and Warnings
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Saizen (somatropin [rDNA origin] for injection)
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
- General
- Intracranial hypertension (IH)
- Drug Interactions
ADVERSE REACTIONS
- Growth Hormone Deficient Adult Patients
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CONTRAINDICATIONS
Saizen is contraindicated in patients with a
known hypersensitivity to somatropin or any of its excipients.
Saizen is contraindicated in patients with
proliferative or preproliferative diabetic retinopathy.
Growth hormone is contraindicated in patients with
Prader-Willi syndrome who are severely obese or have severe
respiratory impairment. Unless patients with Prader-Willi syndrome
also have a diagnosis of growth hormone deficiency, Saizen is not
indicated for the long term treatment of pediatric patients who
have growth failure due to genetically confirmed
Prader-Willi syndrome.
WARNINGS
There have been reports of fatalities after
initiating therapy with growth hormone in pediatric patients with
Prader-Willi syndrome who had one or more of the following risk
factors: severe obesity, history of upper airway obstruction or
sleep apnea, or unidentified respiratory infection. Male patients
with one or more of these factors may be at greater risk than
females. Patients with Prader-Willi syndrome should be evaluated
for signs of upper airway obstruction and sleep apnea before
initiation of treatment with growth hormone. If, during treatment
with growth hormone, patients show signs of upper airway
obstruction (including onset of or increased snoring) and/or new
onset sleep apnea, treatment should be interrupted. All patients
with Prader-Willi syndrome treated with growth hormone should also
have effective weight control and be monitored for signs of
respiratory infection, which should be diagnosed as early as
possible and treated aggressively. Unless patients with
Prader-Willi syndrome also have a diagnosis of growth hormone
deficiency, Saizen is not indicated for the long term treatment of
pediatric patients who have growth failure due to genetically
confirmed Prader-Willi syndrome.
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Sustiva (efavirenz) Capsules and Tablets
(click product name to read prescribing information)
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CONTRAINDICATIONS
WARNINGS
- Psychiatric Symptoms
- Nervous System Symptoms
PRECAUTIONS
- Immune Reconstitution Syndrome
- Table 5a:
- Drugs That Should Not Be Coadministered
with Sustiva
- Established Drug Interaction Table
ADVERSE REACTIONS
-
Table 9
-
Liver Enzymes
-
Lipids
PATIENT PACKAGE INSERT
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CONTRAINDICATIONS
Sustiva should not be administered concurrently
with voriconazole because Sustiva significantly decreases
voriconazole plasma concentrations.
WARNINGS
Psychiatric Symptoms
Serious psychiatric adverse experiences have been
reported in patients treated with Sustiva..... Other factors
associated with an increase in the occurrence of these psychiatric
symptoms were history of injection drug use, psychiatric history,
and receipt of psychiatric medication at study entry.... (Please see
details in prescribing information.)
Nervous System
Analysis of long-term data from Study 006 (median
follow-up 180 weeks, 102 weeks, and 76 weeks for patients treated
with Sustiva + zidovudine + lamivudine, Sustiva + indinavir, and
indinavir + zidovudine + lamivudine, respectively) showed that,
beyond 24 weeks of therapy, the incidences of new-onset nervous
system symptoms among Sustiva-treated patients were generally
similar to those in the indinavir-containing control arm. |
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Adderall XR (mixed salts of a single-entity
amphetamine product)
(click product name to read prescribing information)
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BOXED WARNING
WARNINGS
- Sudden Death and Pre-existing Structural Cardiac
Abnormalities
PRECAUTIONS
- Carcinogenesis/Mutagenesis and Impairment of
Fertility
- Pregnancy
ADVERSE REACTIONS
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BOXED WARNING
Misuse of amphetamine may cause sudden death and
serious cardiovascular adverse events.
WARNINGS
Sudden death has been reported in association
with amphetamine treatment at usual doses in children with
structural cardiac abnormalities. Adderall XR generally should
not be used in children or adults with structural cardiac
abnormalities.
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Hepsera (adefovir dipivoxil) Tablets
(click product name to read prescribing information)
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BOXED WARNING
WARNINGS
- Exacerbations of Hepatitis after Discontinuation
of Treatment
ADVERSE REACTIONS
PATIENT PACKAGE INSERT |
BOXED WARNING
Severe acute exacerbations of hepatitis have
been reported in patients who have discontinued anti-hepatitis B
therapy (including Hepsera). Hepatic function should be monitored
closely with both clinical and laboratory follow-up for at least
several months in patients who discontinue anti-hepatitis B
therapy. If appropriate, resumption of anti-hepatitis B therapy
may be warranted.
WARNINGS
Severe acute exacerbation of hepatitis has been
reported in patients who have discontinued anti-hepatitis B
therapy, including therapy with Hepsera. Hepatic function should
be monitored at repeated intervals with both clinical and
laboratory follow-up for at least several months in patients who
discontinue Hepsera. If appropriate, resumption of
anti-hepatitis B therapy may be warranted.
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Vivelle (estradiol transdermal
system)
(click product name to read prescribing information) |
BOXED WARNING
- Cardiovascular and Other Risks
- Women's Health Initiative Memory Study (WHIMS)
WARNINGS
PRECAUTIONS
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BOXED WARNING
The Women's Health Initiative Memory Study
(WHIMS), a substudy of WHI, reported increased risk of
developing probable dementia in postmenopausal women 65 years of
age or older during 4 years of treatment with oral conjugated
estrogens plus medroxyprogesterone acetate relative to placebo.
It is unknown whether this finding applies to younger
postmenopausal women or to women taking estrogen alone therapy.
WARNINGS
In the Women's Health Initiative Memory Study
(WHIMS), 4,532 generally healthy postmenopausal women 65 years
of age and older were studied, of whom 35% were 70 to 74 years
of age and 18% were 75 or older. After an average follow-up of 4
years, 40 women being treated with CE/MPA (1.8%, n = 2,229) and
21 women in the placebo group (0.9%, n = 2,303) received
diagnoses of probable dementia. The relative risk for CE/MPA
versus placebo was 2.05 (95% confidence interval 1.21 - 3.48),
and was similar for women with and without histories of
menopausal hormone use before WHIMS. The absolute risk of
probable dementia for CE/MPA versus placebo was 45 versus 22
cases per 10,000 women-years, and the absolute excess risk for
CE/MPA was 23 cases per 10,000 women years. It is unknown
whether these findings apply to younger postmenopausal women. |
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Vivelle-Dot (estradiol transdermal system)
(click product name to read prescribing information)
|
BOXED WARNING
- Cardiovascular and Other Risks
- Women's Health Initiative Memory Study (WHIMS)
WARNINGS
PRECAUTIONS
|
BOXED WARNING
The Women's Health Initiative Memory Study
(WHIMS), a substudy of WHI, reported increased risk of
developing probable dementia in postmenopausal women 65 years of
age or older during 4 years of treatment with oral conjugated
estrogens plus medroxyprogesterone acetate relative to placebo.
It is unknown whether this finding applies to younger
postmenopausal women or to women taking estrogen alone therapy.
WARNINGS
In the Women's Health Initiative Memory Study
(WHIMS), 4,532 generally healthy postmenopausal women 65 years
of age and older were studied, of whom 35% were 70 to 74 years
of age and 18% were 75 or older. After an average follow-up of 4
years, 40 women being treated with CE/MPA (1.8%, n = 2,229) and
21 women in the placebo group (0.9%, n = 2,303) received
diagnoses of probable dementia. The relative risk for CE/MPA
versus placebo was 2.05 (95% confidence interval 1.21 - 3.48),
and was similar for women with and without histories of
menopausal hormone use before WHIMS. The absolute risk of
probable dementia for CE/MPA versus placebo was 45 versus 22
cases per 10,000 women-years, and the absolute excess risk for
CE/MPA was 23 cases per 10,000 women years. It is unknown
whether these findings apply to younger postmenopausal women. |
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Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Actos (pioglitazone HCl) Tablets
(click product name to read prescribing information)
|
WARNINGS
-
Cardiac Failure and Other Cardiac Effects
-
In Type 2 Diabetes and Congestive Heart
Failure (Systolic Dysfunction)
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A 24-week post-marketing safety study was
performed to compare Actos (n=262) to glyburide (n=256) in
uncontrolled diabetic patients (mean HbA1C
8.8% at baseline) with NYHA Class II
and III heart failure and ejection fraction less than 40% (mean
EF 30% at baseline). Over the course of the study, overnight
hospitalization for congestive heart failure was reported in
9.9% of patients on Actos compared to 4.7% of patients on
glyburide with a treatment difference observed from 6 weeks.
This adverse event associated with Actos was more marked in
patients using insulin at baseline and in patients over 64 years
of age. No difference in cardiovascular mortality between the
treatment groups was observed.
Actos should be initiated at
the lowest approved dose if it is prescribed for patients with
type 2 diabetes and systolic heart failure (NYHA Class II). If
subsequent dose escalation is necessary, the dose should be
increased gradually only after several months of treatment with
careful monitoring for weight gain, edema, or signs and symptoms
of CHF exacerbation. |
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Amicar (aminocaproic acid) Tablets, Injection and
Syrup
(click product name to read prescribing information)
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WARNINGS PRECAUTIONS
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Amicar Injection contains benzyl alcohol as a preservative. The
administration of medications containing benzyl alcohol as a
preservative to premature neonates has been associated with fatal
"Gasping Syndrome".
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Geodon (ziprasidone HCl) Capsules
Geodon (ziprasidone mesylate) for Injection (for
IM Use Only)
(click product name to read prescribing information)
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WARNINGS
-
Hyperglycemia and Diabetes Mellitus
PRECAUTIONS
ADVERSE REACTIONS
- Initial Paragraph
- Fifth Paragraph
- Adverse Findings Observed in Short-Term, Placebo-Controlled
Trials with Oral Ziprasidone
- Adverse Events Associated with Discontinuation of Treatment
in Short-Term, Placebo-Controlled Trials of Oral Ziprasidone
- Commonly Observed Adverse Events in Short-Term, Placebo-Controlled
Trials
- Adverse Events Occurring at an Incidence of 2% or More Among
Ziprasidone-Treated Patients in Short-Term, Oral,
Placebo-Controlled Trials
- Dose Dependency of Adverse Events in Short-Term, Fixed-Dose,
Placebo-Controlled Trials
- Extrapyramidal Symptoms (EPS)
- Weight Gain
- ECG Changes
- Other Adverse Events Observed During the Premarketing
Evaluation of Oral Ziprasidone
- Cardiovascular System
- Tachycardia
- Postural Hypotension
- Digestive System
- Musculoskeletal System
- Special Senses
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Hyperglycemia, in some cases extreme and
associated with ketoacidosis or hyperosmolar coma or death, has
been reported in patients treated with atypical antipsychotics.
There have been few reports of hyperglycemia or diabetes in
patients treated with Geodon. Although fewer patients have been
treated with Geodon, it is not known if this more limited
experience is the sole reason for the paucity of such reports.
Assessment of the relationship between atypical antipsychotic use
and glucose abnormalities is complicated by the possibility of an
increased background risk of diabetes mellitus in patients with
schizophrenia and the increasing incidence of diabetes mellitus in
the general population.
Patients with an established diagnosis of diabetes
mellitus who are started on atypical antipsychotics should be
monitored regularly for worsening of glucose control. Patients
with risk factors for diabetes mellitus (e.g., obesity, family
history of diabetes) who are starting treatment with atypical
antipsychotics should undergo fasting blood glucose testing at the
beginning of treatment and periodically during treatment. Any
patient treated with atypical antipsychotics should be monitored
for symptoms of hyperglycemia including polydipsia, polyuria,
polyphagia, and weakness. Patients who develop symptoms of
hyperglycemia during treatment with atypical antipsychotics should
undergo fasting blood glucose testing. In some cases,
hyperglycemia has resolved when the atypical antipsychotic was
discontinued; however, some patients required continuation of
antidiabetic treatment despite discontinuation of the suspect
drug.
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Junior Strength Advil (100 mg ibuprofen) Tablets
(click product name to read prescribing information)
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WARNINGS
ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- Ulcers
- Bleeding problems
- Stomach problems that last or come back, such as heartburn,
upset stomach or pain
- High blood pressure, heart or kidney disease or is taking a
diuretic
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- Taking a prescription drug for anticoagulation (blood
thinning)
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Taking more than recommended may cause stomach bleeding.
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Lotrel (amlodipine besylate and benazepril
hydrochloride) Combination Capsules
(click product name to read prescribing information)
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WARNINGS
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Intestinal angioedema has been reported in
patients treated with ACE inhibitors. These patients presented
with abdominal pain (with and without nausea or vomiting); in
some cases there was no prior history of facial angioedema and
C-1 esterase levels were normal. The angioedema was diagnosed
by procedures including abdominal CT scan or ultrasound, or at
surgery, and symptoms resolved after stopping the ACE
inhibitor. Intestinal angioedema should be included in the
differential diagnosis of patients on ACE inhibitors
presenting with abdominal pain. |
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Naropin (ropivacaine HCl) Injection
(click product name to read prescribing information)
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WARNINGS
PRECAUTIONS
|
Prior
to receiving major blocks the general condition of the patient
should be optimized and the patient should have an IV line
inserted. All necessary precautions should be taken to avoid
intravascular injection.
Patients treated with class III antiarrhythmic drugs (eg. amiodarone) should be under close surveillance and ECG monitoring
considered, since cardiac effects may be additive.
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Orudis KT (ketoprofen) Tablets
(click product name to read prescribing information)
|
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
- Stomach problems that last or come back, such as heartburn,
upset stomach, or pain
- Ulcers
- Bleeding problems
- High blood pressure, heart or kidney disease, are taking a
diuretic, or are over 65 years of age
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- Under a doctor's care for any serious medical condition
- Taking a prescription drug for anticoagulation (blood
thinning)
- Taking any other drug
When using this product take with food or milk if stomach upset
occurs
STOP USE AND ASK A DOCTOR IF
- Stomach pain or upset gets worse or lasts
- Redness or swelling is present in the painful area
- Any new symptoms appear
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Taking more than
recommended may cause stomach bleeding. |
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Pexeva (paroxetine mesylate) Tablets
(click product name to read prescribing information)
|
WARNINGS
- Clinical Worsening
and Suicide Risk
PRECAUTIONS
-
General
-
Information for Patients
-
Drug Interactions
- Drugs That Interfere
With Hemostasis (NSAIDs, Aspirin, Warfarin,
etc.)
- Pregnancy
|
Patients with major depressive disorder, both
adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality),
whether or not they are taking antidepressant medications, and
this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may
have a role in inducing worsening of depression and the emergence
of suicidality in certain patients, a causal role for
antidepressants in inducing such behaviors has not been
established. Nevertheless, patients being treated with
antidepressants should be observed closely for clinical worsening
and suicidality, especially at the beginning of a course of drug
therapy, or at the time of dose changes, either increases or
decreases. Consideration should be given to changing the
therapeutic regimen, including possibly discontinuing the
medication, in patients whose depression is persistently worse or
whose emergent suicidality is severe, abrupt in onset, or was not
part of the patient's presenting symptoms. |
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Prozac (fluoxetine hydrochloride) Pulvules,
Tablets, Solution and Delayed-Release Capsules
(click product name to read prescribing information)
|
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
-
General
-
Information for Patients
-
Drug Interactions
- Drugs That Interfere
With Hemostasis (NSAIDs, Aspirin, Warfarin,
etc.)
- Pregnancy
|
Patients with major depressive disorder, both
adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality),
whether or not they are taking antidepressant medications, and
this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may
have a role in inducing worsening of depression and the emergence
of suicidality in certain patients, a causal role for
antidepressants in inducing such behaviors has not been
established. Nevertheless, patients being treated with
antidepressants should be observed closely for clinical worsening
and suicidality, especially at the beginning of a course of drug
therapy, or at the time of dose changes, either increases or
decreases. Consideration should be given to changing the
therapeutic regimen, including possibly discontinuing the
medication, in patients whose depression is persistently worse or
whose emergent suicidality is severe, abrupt in onset, or was not
part of the patient's presenting symptoms. |
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Zoloft (sertraline hydrochloride) Tablets and Oral
Concentrate
(click product name to read prescribing information)
|
WARNINGS
- Clinical Worsening and
Suicide Risk
PRECAUTIONS
-
General
-
Information for Patients
-
Drug Interactions
- Drugs That Interfere
With Hemostasis (Non-Selective NSAIDs, Aspirin, Warfarin,
etc.)
- Pregnancy
|
Patients with major depressive disorder, both
adult and pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior (suicidality),
whether or not they are taking antidepressant medications, and
this risk may persist until significant remission occurs. Although
there has been a long-standing concern that antidepressants may
have a role in inducing worsening of depression and the emergence
of suicidality in certain patients, a causal role for
antidepressants in inducing such behaviors has not been
established. Nevertheless, patients being treated with
antidepressants should be observed closely for clinical worsening
and suicidality, especially at the beginning of a course of drug
therapy, or at the time of dose changes, either increases or
decreases. Consideration should be given to changing the
therapeutic regimen, including possibly discontinuing the
medication, in patients whose depression is persistently worse or
whose emergent suicidality is severe, abrupt in onset, or was not
part of the patient's presenting symptoms. |
MedWatch
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Back to Summary Page
MedWatch
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Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
MedWatch
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Report | How to Report | Download
Forms | Join the E-list | Comments
Back to Summary Page
|
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