Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications and Warnings
|
Premarin Intravenous (conjugated estrogens, USP) for
Injection
(click product name to read prescribing information)
|
BOXED WARNING
- Cardiovascular and Other Risks
WARNINGS
- Cardiovascular Disorders
- Stroke
- Coronary Heart Disease
- Venous Thromboembolism (VTE)
- Malignant Neoplasms
- Dementia
PRECAUTIONS
|
BOXED WARNING
The estrogen-alone substudy of the Women's
Health Initiative (WHI) reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79
years of age) during 6.8 years and 7.1 years, respectively, of
treatment with oral conjugated estrogens (CE 0.625 mg) per day
relative to placebo.
WARNINGS
Cardiovascular Disorders
Estrogen-alone therapy has been associated with
an increased risk of stroke and DVT.....
Stroke
In the estrogen-alone substudy of the WHI study,
a statistically significant increased risk of stroke was
reported.....
In the estrogen-plus-progestin substudy of WHI,
a statistically significant increased risk of stroke was
reported in women receiving CE/MPA 0.625 mg/2.5 mg daily
compared to women receiving placebo (31 vs. 24 per 10,000
women-years).....
Coronary Heart Disease
In the estrogen-alone substudy of WHI, no
overall effect on coronary heart disease (CHD) events (defined
as non-fatal MI, silent MI, or death, due to CHD) was reported
in women receiving estrogen alone compared to placebo.
In the estrogen-plus-progestin substudy of WHI,
no statistically significant increase of CHD events was reported
in women receiving CE/MPA compared to women receiving
placebo.....
Venous Thromboembolism (VTE)
In the estrogen-alone substudy of WHI, the risk
of VTE (DVT and pulmonary embolism [PE]), was reported to be
increased for women taking conjugated estrogens (30 vs. 22 per
10,000 women-years), although only the increased risk of DVT
reached statistical significance (23 vs. 15 per 10,000
women-years). The increase in VTE risk was demonstrated during
the first two years.....
In the estrogen-plus-progestin substudy of WHI,
a statistically significant 2-fold greater rate of VTE was
reported in women receiving CE/MPA compared to women receiving
placebo (35 vs. 17 per 10,000 women-years). Statistically
significant increases in risk for both DVT (26 vs. 13 per 10,000
women-years) and PE (18 vs. 8 per 10,000 women-years) were also
demonstrated.....
Malignant Neoplasms
Breast Cancer
In the estrogen-alone substudy of WHI, after an
average of 7.1 years of follow-up, CE (0.625 mg daily) was not
associated with an increased risk of invasive breast cancer (RR
0.80, 95% nCI 0.62-1.04)......
Dementia
When data from the two populations were pooled
as planned in the WHIMS protocol, the reported overall relative
risk for probable dementia was 1.76 (95% CI 1.19-2.60)..... |
|
|
|
Premarin (conjugated estrogens tablets, USP)
(click product name to read prescribing information)
|
BOXED WARNING
- Cardiovascular and Other Risks
WARNINGS
- Cardiovascular Disorders
- Coronary Heart Disease
- Venous Thromboembolism (VTE)
- Malignant Neoplasms
PATIENT PACKAGE INSERT
|
BOXED WARNING
The estrogen-alone substudy of the Women's
Health Initiative (WHI) reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79
years of age) during 6.8 years and 7.1 years, respectively, of
treatment with oral conjugated estrogens (CE 0.625 mg) per day
relative to placebo.
WARNINGS
Cardiovascular Disorders
Estrogen-alone therapy has been associated with
an increased risk of stroke and DVT.....
Coronary Heart Disease
In the estrogen-alone substudy of WHI, no
overall effect on coronary heart disease (CHD) events (defined
as non-fatal MI, silent MI, or death, due to CHD) was reported
in women receiving estrogen alone compared to placebo.
Venous Thromboembolism (VTE)
In the estrogen-alone substudy of WHI, the risk
of VTE (DVT and pulmonary embolism [PE]), was reported to be
increased for women taking conjugated estrogens (30 vs. 22 per
10,000 women-years), although only the increased risk of DVT
reached statistical significance (23 vs. 15 per 10,000
women-years). The increase in VTE risk was demonstrated during
the first two years.
Malignant Neoplasms
Breast Cancer
.....In the estrogen-alone substudy of WHI,
after an average of 7.1 years of follow-up, CE (0.625 mg daily)
was not associated with an increased risk of invasive breast
cancer (RR 0.80, 95% nCI 0.62-1.04).
The use of estrogen alone and estrogen plus
progestin has been reported to result in an increase in abnormal
mammograms requiring further evaluation.
|
|
|
|
Premarin (conjugated estrogens) Vaginal Cream
(click product name to read prescribing information)
|
BOXED WARNING
- Cardiovascular and Other Risks
WARNINGS
- Cardiovascular Disorders
- Stroke
- Coronary Heart Disease
- Venous Thromboembolism (VTE)
- Malignant Neoplasms
- Dementia
PRECAUTIONS
PATIENT PACKAGE INSERT
|
BOXED WARNING
The estrogen-alone substudy of the Women's
Health Initiative (WHI) reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79
years of age) during 6.8 years and 7.1 years, respectively, of
treatment with oral conjugated estrogens (CE 0.625 mg) per day
relative to placebo.
WARNINGS
Cardiovascular Disorders
Estrogen-alone therapy has been associated with
an increased risk of stroke and DVT.....
Stroke
In the estrogen-alone substudy of the WHI study,
a statistically significant increased risk of stroke was
reported....
In the estrogen-plus-progestin substudy of WHI,
a statistically significant increased risk of stroke was
reported in women receiving CE/MPA 0.625 mg/2.5 mg daily
compared to women receiving placebo (31 vs. 24 per 10,000
women-years).....
Coronary Heart Disease
In the estrogen-alone substudy of WHI, no
overall effect on coronary heart disease (CHD) events (defined
as non-fatal MI, silent MI, or death, due to CHD) was reported
in women receiving estrogen alone compared to placebo.
In the estrogen-plus-progestin substudy of WHI,
no statistically significant increase of CHD events was reported
in women receiving CE/MPA compared to women receiving placebo
(39 vs. 33 per 10,000 women-years). An increase in relative risk
was demonstrated in year one, and a trend toward decreasing
relative risk was reported in years 2 through 5.
Venous Thromboembolism (VTE)
In the estrogen-alone substudy of WHI, the risk
of VTE (DVT and pulmonary embolism [PE]), was reported to be
increased for women taking conjugated estrogens (30 vs. 22 per
10,000 women-years), although only the increased risk of DVT
reached statistical significance (23 vs. 15 per 10,000
women-years). The increase in VTE risk was demonstrated during
the first two years.
In the estrogen-plus-progestin substudy of WHI,
a statistically significant 2-fold greater rate of VTE was
reported in women receiving CE/MPA compared to women receiving
placebo (35 vs. 17 per 10,000 women-years). Statistically
significant increases in risk for both DVT (26 vs. 13 per 10,000
women-years) and PE (18 vs. 8 per 10,000 women years) were also
demonstrated.....
Malignant Neoplasms
Breast Cancer
.....In the estrogen-alone substudy of WHI,
after an average of 7.1 years of follow-up, CE (0.625 mg daily)
was not associated with an increased risk of invasive breast
cancer (RR 0.80, 95% nCI 0.62-1.04).
The use of estrogen alone and estrogen plus
progestin has been reported to result in an increase in abnormal
mammograms requiring further evaluation.
Dementia
When data from the two populations were pooled
as planned in the WHIMS protocol, the reported overall relative
risk for probable dementia was 1.76 (95% CI 1.19-2.60)..... |
|
|
|
Prempro (conjugated estrogens/medroxyprogesterone
acetate tablets)
Premphase (conjugated
estrogens/medroxyprogesterone tablets)
Please contact Wyeth Pharmaceuticals Inc. at
1-800-395-9938 for prescribing information.
|
BOXED WARNING
- Cardiovascular and Other Risks
WARNINGS
- Cardiovascular Disorders
- Stroke
- Coronary Heart Disease
- Venous Thromboembolism (VTE)
- Malignant Neoplasms
- Dementia
PRECAUTIONS
PATIENT PACKAGE INSERT |
This supplemental NDA includes labeling
revisions based on final adjudicated data for 7.1 years of
treatment from the Women's Health Initiative (WHI)
estrogen-alone substudy on coronary heart disease (CHD), deep
vein thrombosis (DVT), stroke, and breast cancer. |
MedWatch
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Back to Summary Page
Brand (Generic) Name |
Sections Modified |
Summary of Changes to Contraindications
and Warnings |
Camptosar (irinotecan hydrochloride injection) for
Intravenous Use Only
(click product name to read prescribing information)
|
CONTRAINDICATIONS
PRECAUTIONS
- General
- Patients at Particular Risk
- Irinotecan commonly causes neutropenia,
leucopenia, and anemia, any of which may be severe and
therefore should not be used in patients with severe bone
marrow failure. Patients must not be treated with irinotecan
until resolution of the bowel obstruction. Patients with
hereditary fructose intolerance should not be given Camptosar,
as this product contains sorbitol.
- Information for Patients
- Loperamide is not recommended to be used for
more than 48 consecutive hours at these doses, because of the
risk of paralytic ileus.
- Patients should be warned about the potential
for dizziness or visual disturbances which may occur within 24
hours following the administration of Camptosar.....
ADVERSE REACTIONS
- Overview of Adverse Events
- Respiratory
- Interstitial pulmonary disease presenting as
pulmonary infiltrates is uncommon during irinotecan
therapy.....
- Post-marketing Experience
|
Camptosar Injection is contraindicated in patients
with a known hypersensitivity to the drug or its excipients.
|
|
|
|
Oncaspar (pegaspargase)
Intravenous or Intramuscular Injection
(click product name to read prescribing information)
Read about new prescription drug label format. |
CONTRAINDICATIONS WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- Clinical Trials Experience
- Clinical Allergic Reactions
PATIENT COUNSELING INFORMATION |
CONTRAINDICATIONS History of serious thrombosis with prior L-asparaginase
therapy. WARNINGS AND PRECAUTIONS
Serious thrombotic events, including sagittal
sinus thrombosis can occur in patients receiving Oncaspar.
Discontinue Oncaspar in patients with serious thrombotic event. |
|
|
|
Symbyax (olanzapine and fluoxetine HCl capsules)
(click product name to read prescribing information) |
CONTRAINDICATIONS
PRECAUTIONS
- Drug Interactions
- Pediatric Use
ADVERSE REACTIONS
- Other Events Observed with Olanzapine or
Fluoxetine Monotherapy
|
Pimozide -
Concomitant use in patients taking
pimozide is contraindicated. |
|
|
|
Zanaflex (tizanidine hydrochloride) Capsules and
Tablets
(click product name to read prescribing information)
|
CONTRAINDICATIONS
WARNINGS
- Hypotension
- Use in Patients with Hepatic Impairment
- Potential Interaction with Fluvoxamine or
Ciprofloxacin
PRECAUTIONS
- Information for Patients
- Because of the potential for the increased
risk of serious adverse reactions including severe lowering of
blood pressure and sedation.....
- Drug Interactions
- Fluvoxamine
- Ciproflaxacin
- CYP1A2 Inhibitors
|
CONTRAINDICATIONS
Concomitant use of tizanidine with fluvoxamine or
with ciprofloxacin, potent inhibitors of CYP1A2, is
contraindicated. Significant alterations of pharmacokinetic
parameters of tizanidine including increased AUC, t1/2, Cmax,
increased oral bioavailability and decreased plasma clearance have
been observed with concomitant administration of either
fluvoxamine or ciprofloxacin. This pharmacokinetic interaction can
result in potentially serious adverse events.
WARNINGS
Hypotension
Clinically significant hypotension (decreases in
both systolic and diastolic pressure) has been reported with
concomitant administration of either fluvoxamine or ciprofloxacin
and single doses of 4 mg of tizanidine.....
Use in Patients with Hepatic Impairment
The influence of hepatic impairment on the
pharmacokinetics of tizanidine has not been evaluated. Because tizanidine
is extensively metabolized in the liver, hepatic impairment
would be expected to have significant effects on the
pharmacokinetics of tizanidine. Tizanidine should ordinarily be
avoided or used with extreme caution in patients with hepatic
impairment.
Potential Interaction with Fluvoxamine or
Ciprofloxacin
See prescribing information for new text. |
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Back to Summary Page
Brand (Generic) Name
|
Sections Modified |
Summary of Changes to Contraindications
and Warnings
|
Adderall (mixed salts of a single-entity
amphetamine product) 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
PRECAUTIONS
- General
- Drug Interactions
- Alkalinizing Agents
- Co-administration of Adderall and gastrointestinal
alkalizing agents, such as antacids....
-
Carcinogenesis/Mutagenesis and Impairment of Fertility
- Pregnancy
- Teratogenic Effects: Pregnancy Category C
- Using in Nursing Mothers
ADVERSE REACTIONS
- Allergic
- .....rash, hypersensitivity reactions including angioedema
and anaphylaxis. Serious skin rashes, including Stevens
Johnson Syndrome.....
|
See prescribing information for new WARNINGS
information.
|
|
|
|
Adderall XR (mixed salts of a single entity amphetamine
product) 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
PRECAUTIONS
- General
- Drug Interactions
- Alkalinizing Agents
- Co-administration of Adderall XR and gastrointestinal
alkalizing agents, such as antacids....
-
Carcinogenesis/Mutagenesis and Impairment of Fertility
- Pregnancy
- Teratogenic Effects: Pregnancy Category C
- Using in Nursing Mothers
ADVERSE REACTIONS
- Allergic
- .....rash, hypersensitivity reactions including angioedema
and anaphylaxis. Serious skin rashes, including Stevens
Johnson Syndrome.....
|
See prescribing information
for new WARNINGS information. |
|
|
|
Alimta (pemetrexed for injection)
(click product name to read prescribing information)
|
WARNINGS
ADVERSE REACTIONS
- Post-marketing Experience
- The following adverse events have been
identified during post-approval use of Alimta. These events
have occurred with Alimta when used as a single-agent and in
combination therapies.....
- Gastrointestinal
- Rare cases of colitis.....
|
Alimta can suppress bone marrow function, as
manifested by neutropenia, thrombocytopenia, and anemia (or
pancytopenia); myelosuppression is usually the dose-limiting
toxicity.....
|
|
|
|
Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Biaxin Granules (clarithromycin for oral suspension, USP)
Please contact Abbott Laboratories at 1-800-633-9110 for
prescribing information.
|
WARNINGS
PRECAUTIONS
- Drug Interactions
- Geriatric Use
ADVERSE REACTIONS
- Post-marketing Experience
|
WARNINGS
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
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.
PRECAUTIONS/Geriatric Use
In a steady-state study in which healthy
elderly subjects (age 65 to 81 years old) were given 500 mg
every 12 hours, the maximum serum concentrations and area
under the curves of clarithromycin and 14-OH clarithromycin
were increased compared to those achieved in healthy young
adults. These changes in pharmacokinetics parallel known
age-related decreases in renal function. In clinical trials,
elderly patients did not have an increased incidence of
adverse events when compared to younger patients. Dosage
adjustment should be considered in elderly patients with
severe renal impairment.
ADVERSE REACTIONS
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.
|
|
|
|
Celestone Soluspan (betamethasone sodium
phosphate and betamethasone acetate injectable suspension, USP)
(click product name to read prescribing information)
|
WARNINGS
- General
- Infections
- Special Pathogens
- Strongyloides (threadworm) Infestation
PRECAUTIONS
- Endocrine
- .....Therefore, in any situation of stress
occurring during that period, naturally occurring
glucocorticoids (hydrocortisone and cortisone), which also
have salt-retaining properties, rather than betamethasone, are
the appropriate choices as replacement therapy in
adrenocortical deficiency states.
|
General
In patients on corticosteroid therapy subjected to any unusual
stress hydrocortisone or cortisone is the drug of choice as a
supplement during and after the event.
Infections/Special Pathogens
Similarly, corticosteroids should be used with great care in
patients with known or suspected Strongyloides (threadworm)
infestation. In such patients, corticosteroid-induced
immunosuppression may lead to Strongyloides hyperinfection and
dissemination with widespread larval migration, often accompanied
by severe enterocolitis and potentially fatal gram-negative
septicemia. |
|
|
|
Celestone (betamethasone syrup, USP)
(click product name to read prescribing information)
|
WARNINGS
- General
- Infection
- Special Pathogens
- Strongyloides (threadworm) Infestation
PRECAUTIONS
- Endocrine
- .....Therefore, in any situation of stress
occurring during that period, naturally occurring
glucocorticoids (hydrocortisone and cortisone), which also
have salt-retaining properties, rather than betamethasone, are
the appropriate choices as replacement therapy in
adrenocortical deficiency states.
|
General
In patients on corticosteroid therapy subjected to any unusual
stress hydrocortisone or cortisone is the drug of choice as a
supplement during and after the event.
Infection/Special Pathogens
Similarly, corticosteroids should be used with great care in
patients with known or suspected Strongyloides (threadworm)
infestation. In such patients, corticosteroid-induced
immunosuppression may lead to Strongyloides hyperinfection and
dissemination with widespread larval migration, often accompanied
by severe enterocolitis and potentially fatal gram-negative
septicemia.
|
|
|
|
Daytrana (methylphenidate
transdermal system)
(click product name to read prescribing information) |
WARNINGS
- Serious Cardiovascular Events
- Sudden Death and Pre-existing 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 Disturbance
INFORMATION FOR PARENTS OR CAREGIVERS Using Daytrana
(methylphenidate transdermal system) on a Child for the Treatment
of Attention Deficit Disorder (ADHD)
|
See prescribing information for new WARNINGS
information. |
|
|
|
Retrovir (zidovudine) IV
Infusion for Intravenous Infusion Only
(click product name to read prescribing information) |
WARNINGS
- Use with Interferon- and Ribavirin-Based
Regimens
PRECAUTIONS
- Immune Reconstitution Syndrome
|
In vitro studies have shown ribavirin can reduce
the phosphorylation of pyrimidine nucleoside analogues such as
zidovudine. Although no evidence of a pharmacokinetic or
pharmacodynamic interaction (e.g., loss of HIV/HCV virologic
suppression) was seen when ribavirin was coadministered with
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 Retrovir
should be closely monitored for treatment-associated toxicities,
especially hepatic decompensation, neutropenia, and anemia.
Discontinuation of Retrovir should be considered as medically
appropriate. |
MedWatch
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Back to Summary Page
Brand
(Generic) Name |
Sections Modified |
Famvir (famciclovir)
Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
-
Carcinogenesis, Mutagenesis, Impairment of
Fertility
-
Pregnancy: Teratogenic Effects
- Geriatric Use
ADVERSE REACTIONS
-
Immunocompetent Patients
- Table 5: Selected Adverse Events (all grades and without
regard to causality) Reported by ≥2% of
Patients.....
|
|
|
Oxytrol (oxybutynin transdermal system)
(click product name to read prescribing information)
|
PRECAUTIONS
ADVERSE REACTIONS
PATIENT PACKAGE INSERT
|
|
|
Propranolol Hydrochloride Injection, USP
(click product name to read prescribing information)
|
PRECAUTIONS
- Drug Interactions
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy: Pregnancy Category C
- Nursing Mothers
- Geriatric Use
- Hepatic Insufficiency
ADVERSE REACTIONS
|
|
|
Protonix (pantoprazole
sodium) Delayed-Release Tablets
(click product name to read prescribing
information)
|
PRECAUTIONS
- General
- Atrophic gastritis has been noted
occasionally in gastric corpus biopsies from patients
treated long-term pantoprazole, particularly in patients
who were H. pylori positive.
|
|
|
Revatio (sildenafil citrate) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- General
- .....In the event of an erection that
persists longer than 4 hours, the patient should seek
immediate medical assistance......
- Drug Interactions
- Effects of Revatio on Other Drugs
PATIENT PACKAGE INSERT |
|
|
Risperdal Consta (risperidone) Long-Acting
Injection
(click product name to read prescribing information) |
PRECAUTIONS
- Pregnancy
- .....Reversible extrapyramidal symptoms in
the neonate were observed following postmarketing use of
risperidone during the last trimester of pregnancy.
ADVERSE REACTIONS
|
|
|
Triglide (fenofibrate) Tablets
(click product name to read prescribing information)
|
PRECAUTIONS
-
Information for Patients
- Store products in the original, desiccant
containing bottle.
- Do not consume chipped or broken tablets.
|
|
|
Tygacil (tigecycline) for Injection
(click product name to read prescribing information)
|
PRECAUTIONS
Glycylcycline class antibiotics are structurally
similar to tetracycline class antibiotics and may have similar
adverse effects. Such effects may include: photosensitivity,
pseudotumor cerebri, and anti-anabolic action (which has lead to
increased BUN, azotemia, acidosis, and hyperphosphatemia). As with
other tetracyclines, pancreatitis has been reported with the use
of Tygacil.
ADVERSE REACTIONS
- Post-marketing Experience
|
|
|
Wellbutrin (bupropion
hydrochloride) Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Pregnancy: Teratogenic Effects: Pregnancy
Category C
Change in Pregnancy category from Pregnancy
Category B to Pregnancy Category C. |
|
|
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
(click product name to read prescribing information) |
PRECAUTIONS
- Pregnancy: Teratogenic
Effects: Pregnancy Category C
Change in Pregnancy category from Pregnancy Category B to
Pregnancy Category C.
|
|
|
Zosyn (piperacillin
and tazobactam for Injection)
(click product name to read prescribing information)
|
PRECAUTIONS
ADVERSE REACTIONS
- Adverse Events From Clinical Trials
- Post-marketing Experience
- Post-marketing experience with Zosyn in
pediatric patients suggests a similar safety profile to that
seen in adults.
|
|
|
Zosyn (piperacillin
and tazobactam) in Galaxy Containers
(click product name to read prescribing information) |
PRECAUTIONS
ADVERSE REACTIONS
- Adverse Events From Clinical Trials
- Post-marketing Experience
- Post-marketing experience with Zosyn in
pediatric patients suggests a similar safety profile to that
seen in adults.
|
MedWatch
Home | Safety Information | Submit
Report | How to Report | Download
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Back to Summary Page
Brand
(Generic) Name |
Sections Modified |
Elspar (asparaginase)
(click product name to read prescribing information)
|
ADVERSE REACTIONS
- Pancreatitis
- Coagulopathy
- Central Nervous System Toxicity
|
|
|
Gemzar (gemcitabine HCl) for Injection
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Combination Use in Ovarian Cancer
- Table 12: Adverse Events from Comparative Trial of Gemzar
Plus Carboplatin Versus Single-Agent Carboplatin in Ovarian
Cancer
|
|
|
Tagamet (cimetidine)
Tablets
Please contact GlaxoSmith Kline at
1-888-825-5249 for prescribing information. |
ADVERSE REACTIONS
A large epidemiological study suggested an
increased risk of developing pneumonia in current users of
histamine-2-receptor antagonists (H2RAs)
compared to patients who had stopped H2RA
treatment, with an observed adjusted relative risk of 1.63 (95%
CI, 1.07-2.48). However, a causal relationship between use of H2RAs
and pneumonia has not been established. |
|
|
Vytorin (ezetimibe/simvastatin) Tablets
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Post-marketing Experience
- Ezetimibe
- Hypersensitivity Reactions
PATIENT PACKAGE INSERT |
|
|
WelChol (colesevelam hydrochloride) Tablets
(click product name to read prescribing information) |
ADVERSE REACTIONS
- Post-marketing Experience
- There have been rare reports of elevated
thyroid stimulating hormone (TSH) levels in patients who have
received WelChol co-administered with thyroid hormone
replacement therapy.
|
|
|
Zantac (ranitidine hydrochloride) Injection
Zantac (ranitidine hydrochloride) Injection
Premixed
(click product name to read prescribing information) |
ADVERSE REACTIONS
|
|
|
Zantac (ranitidine hydrochloride)
Tablets and Syrup
Zantac (ranitidine hydrochloride) EFFERdose
Tablets
(click product name to read prescribing information)
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