Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Serotonin Syndrome
Additions
and/or revisions underlined:
Selective
serotonin reuptake inhibitors (SSRIs), including PROZAC, can precipitate
serotonin syndrome,
a potentially life-threatening condition. The risk is increased with
concomitant use of other serotonergic drugs (including triptans, tricyclic
antidepressants, fentanyl, lithium, tramadol, tryptophan, meperidine,
methadone, buspirone, amphetamines, and St. John’s Wort) and with drugs
that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4), Drug Interactions (7.1)].
Serotonin syndrome can also occur when these drugs are used alone.
…
The
concomitant use of PROZAC with MAOIs is contraindicated. In addition, do not
initiate PROZAC in a patient being treated with MAOIs such as linezolid or
intravenous methylene blue. No reports involved the administration of methylene
blue by other routes (such as oral tablets or local tissue injection). If it is
necessary to initiate treatment with an MAOI such as linezolid or intravenous
methylene blue in a patient taking PROZAC, discontinue PROZAC before initiating
treatment with the MAOI [see
Contraindications (4) and Drug Interactions (7.1)].
Monitor
all
patients taking PROZAC for the emergence of serotonin syndrome. Discontinue
treatment with PROZAC and any concomitant serotonergic agents immediately
if the above symptoms occur, and initiate supportive symptomatic treatment. If
concomitant use of PROZAC with other serotonergic drugs is clinically
warranted, inform patients of the increased risk for serotonin syndrome and
monitor for symptoms.
5.7 Increased Risk of Bleeding
Additions and/or revisions underlined:
…Based on data from the published observational studies, exposure to
SSRIs, particularly in the month before delivery, has been associated with a
less than 2-fold increase in the risk of postpartum hemorrhage [see Use in Specific Populations (8.1)]. Bleeding reactions related to SNRIs and SSRIs use have ranged from
ecchymoses, hematomas, epistaxis, and petechiae to life-threatening
hemorrhages.
Patients should be cautioned about the increased
risk of bleeding associated with the concomitant use of fluoxetine and NSAIDs,
aspirin, warfarin, or other drugs that affect coagulation [see Drug Interactions (7.4)].
6
Adverse Reactions
Additions and/or revisions underlined:
…
…
6.2 Postmarketing
Experience
Additions
and/or revisions underlined:
…
Voluntary
reports of adverse reactions temporally associated with PROZAC that have been
received since market introduction and that may have no causal relationship
with the drug include the following: anosmia, aplastic anemia, atrial
fibrillation1, cataract, cerebrovascular accident1,
cholestatic jaundice, drug reaction with eosinophilia and systemic symptoms
(DRESS), dyskinesia (including, for example, a case of
buccal-lingual-masticatory syndrome with involuntary tongue protrusion reported
to develop in a 77-year-old female after 5 weeks of fluoxetine therapy and
which completely resolved over the next few months following drug
discontinuation), eosinophilic pneumonia1, epidermal necrolysis,
erythema multiforme, erythema nodosum, exfoliative dermatitis, galactorrhea,
gynecomastia, heart arrest1, hepatic failure/necrosis,
hyperprolactinemia, hypoglycemia, hyposmia, immune-related hemolytic
anemia, kidney failure, memory impairment, movement disorders developing in
patients with risk factors including drugs associated with such reactions and
worsening of pre-existing movement disorders, optic neuritis, pancreatitis1,
pancytopenia, pulmonary embolism, pulmonary hypertension, QT prolongation,
Stevens-Johnson syndrome, thrombocytopenia1, thrombocytopenic
purpura, ventricular tachycardia (including Torsades de Pointes–type
arrhythmias), vaginal bleeding, and violent behaviors1.
…
7
Drug Interactions
7.3 Other Serotonergic Drugs
Additions
and/or revisions underlined:
The
concomitant use of serotonergic drugs (including other SSRIs, SNRIs, triptans,
tricyclic antidepressants, opioids, lithium, buspirone, amphetamines,
tryptophan, and St. John's Wort) with PROZAC increases the risk of serotonin
syndrome. Monitor patients for signs and symptoms of serotonin syndrome,
particularly during treatment initiation and dosage increases. If serotonin
syndrome occurs, consider discontinuation of PROZAC and/or concomitant
serotonergic drugs [see Warnings and
Precautions (5.2)].
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
…
Risk Summary
Based on data from published observational studies,
exposure to SSRIs, particularly in the month before delivery, has been
associated with a less than 2-fold increase in the risk of postpartum
hemorrhage [see Warnings and Precautions
(5.7) and Clinical Considerations].
…
Maternal Adverse Reactions
Use of PROZAC in the month before delivery may be
associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
Serotonin
Syndrome
Patients
should be cautioned about the risk of serotonin syndrome with the concomitant
use of PROZAC and other serotonergic agents including triptans, tricyclic
antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines,
and St. John’s Wort [see Contraindications
(4.1), Warnings and Precautions (5.2), and Drug Interactions (7.3)].
…
Increased
Risk of
Bleeding
Patients
should be cautioned about the concomitant use of fluoxetine and NSAIDs,
aspirin, warfarin, or other drugs that affect coagulation since combined use of
psychotropic drugs that interfere with serotonin reuptake and these agents have
been associated with an increased risk of bleeding [see Warnings and Precautions (5.7) and Drug Interactions (7.4)].
Patients should be advised to call their healthcare provider if they experience
any increased or unusual bruising or bleeding while taking PROZAC.
…
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
What should I tell
my healthcare provider before taking PROZAC? Ask if you are not sure.
Before
starting PROZAC, tell your healthcare provider if you:
…
Tramadol,
fentanyl, meperidine, methadone, or other opioids
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.17 Sexual Dysfunction
New
subsection added
Use
of SSRIs, including PROZAC, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male
patients, SSRI use may result in ejaculatory delay or failure, decreased
libido, and erectile dysfunction. In female patients, SSRI use may result in
decreased libido and delayed or absent orgasm.
It
is important for prescribers to inquire about sexual function prior to
initiation of PROZAC and to inquire specifically about changes in sexual
function during treatment, because sexual function may not be spontaneously
reported. When evaluating changes in sexual function, obtaining a detailed
history (including timing of symptom onset) is important because sexual
symptoms may have other causes, including the underlying psychiatric disorder.
Discuss potential management strategies to support patients in making informed
decisions about treatment.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
underlined
…
Call
your healthcare provider right away if you have any of the following symptoms,
or call 911 if an emergency. PROZAC may be associated with these serious side
effects:
…
11. ![]()
Sexual problems (dysfunction). Taking selective
serotonin reuptake inhibitors (SSRIs), including PROZAC, may cause sexual
problems.
Decreased sex drive
Delayed orgasm or inability to have an orgasm
Talk
to your healthcare provider if you develop any changes in your sexual function
or if you have any questions or concerns about sexual problems during treatment
with PROZAC. There may be treatments your healthcare provider can suggest.
…
PATIENT COUNSELING INFORMATION
Additions
underlined
…
Sexual
Dysfunction
Advise
patients that use of PROZAC may cause symptoms of sexual dysfunction in both
male and female patients.
Inform
patients that they should discuss any changes in sexual function and potential
management strategies with their healthcare provider [see Warnings and Precautions (5.17)].
…
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(PLLR conversion,
please refer to label for complete information)
8.2 Lactation
(PLLR conversion)
Risk Summary
Data
from published literature report the presence of fluoxetine and norfluoxetine
in human milk (see Data). There are
reports of agitation, irritability, poor feeding, and poor weight gain in
infants exposed to fluoxetine through breast milk (see Clinical Considerations). There are no data on the effect of
fluoxetine or its metabolites on milk production. The developmental and health
benefits of breastfeeding should be considered along with the mother’s clinical
need for PROZAC and any potential adverse effects on the breastfed child from
PROZAC or the underlying maternal condition.
Clinical
Considerations
Infants
exposed to PROZAC should be monitored for agitation, irritability, poor
feeding, and poor weight gain.
Data
A
study of 19 nursing mothers on fluoxetine with daily doses of 10-60 mg showed
that fluoxetine was detectable in 30% of nursing infant sera (range: 1 to 84
ng/mL) whereas norfluoxetine was found in 85% (range: <1 to 265 ng/mL).
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions
underlined)
…
What should I tell
my healthcare provider before taking PROZAC? Ask if you are not sure.
Before
starting PROZAC, tell your healthcare provider if you:
…
…
PATIENT COUNSELING INFORMATION
(additions
underlined)
…
Use
in Specific Populations
Pregnancy — Advise
pregnant women to notify their healthcare provider if they become pregnant
or intend to become pregnant during treatment with PROZAC.
Advise
patients that PROZAC use later in pregnancy may lead to increased risk for
neonatal complications requiring prolonged hospitalization, respiratory
support, tube feeding, and/or persistent pulmonary hypertension of the newborn
(PPHN).
Advise
women that there is a pregnancy exposure registry that monitors pregnancy
outcomes in women exposed to PROZAC during pregnancy.
Lactation —Advise
breastfeeding women using PROZAC to monitor infants for agitation,
irritability, poor feeding and poor weight gain and to seek medical care if
they notice these signs.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Serotonin Syndrome
Additions
and/or revisions underlined:
The development of a potentially
life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including
PROZAC, alone but particularly with concomitant use of other serotonergic drugs
(including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol,
tryptophan, buspirone, amphetamines, and St. Johns Wort) and …
If concomitant use of PROZAC with other
serotonergic drugs including triptans, tricyclic antidepressants, fentanyl,
lithium, tramadol, buspirone, tryptophan, amphetamines, and St. Johns
Wort is clinically warranted, patients should be made aware of a potential
increased risk for serotonin syndrome, particularly during treatment initiation
and dose increases …
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Addition
underlined:
Before
starting PROZAC, tell your healthcare provider if you:
Are taking certain drugs or treatments
such as:
PATIENT COUNSELING INFORMATION
17.3
Serotonin Syndrome
Additions
and/or revisions underlined:
Patients should be cautioned about the
risk of serotonin syndrome with the concomitant use of PROZAC and other
serotonergic agents including triptans, tricyclic antidepressants, fentanyl,
lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s
Wort …
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