Black Box Warnings
Stay Informed on Medication Side Effects
Black box warnings (BBW) are the strictest warning labels used when labeling
medication. In the BBW, you will find a list of hazards and side effects
that could have serious, even life-threatening consequences if ignored.
Even medications prescribed by your doctor can be dangerous if taken incorrectly.
Below you will find a few black box warnings for medications hospital
patients commonly take. For BBWs and precautions for other drugs please
visit this website:
Arixtra / Lovenox
Spinal/Epidural hematomas: Patients anticoagulated with low molecular weight
heparins (LMWHs) or fondaparinux are at risk of developing an epidural
or spinal hematoma that can result in long-term or permanent paralysis
when neuraxial anesthesia or spinal puncture is employed.
Frequently monitor patients for signs and symptoms of neurological impairment.
If neurologic compromise is noted, urgent treatment is necessary.
Warfarin can cause major or fatal bleeding and is more likely to occur
during the starting period and with a higher dose. Regular monitoring
of INR should be performed on all treated patients and careful dose adjustment
to desired INR. Consider employing the pharmacist warfarin dosing service
Fentanyl Transdermal Patches
Fentanyl transdermal systems contain a high concentration of fentanyl which
has a high potential for abuse and an associated risk of fatal overdose
caused by respiratory depression. Only use fentanyl transdermal system
in patients who are opioid tolerant. Patients who are considered opioid
tolerant are those who have been taking, for a week or longer, morphine
60 mg/day or more, or oral oxycodone 30 mg/day or more, or oral hydromorphone
8 mg/day or more, or an equianalgesic dose of another opioid.
Fentanyl transdermal is
Contraindicated in patients who are not opioid tolerant, in the management of acute or
mild pain, in the management of acute or postoperative pain or intermittent
pain responsive to as needed or non-opioid therapy, or in doses exceeding
25mcg/h at the initiation or opioid therapy. Peak fentanyl levels occur
between 24 and 72 hours of treatment. Note that serious or life-threatening
hypoventilation may occur, even in opioid-tolerant patients, during the
initial application period.
Furosemide is a potent diuretic and given in excessive amounts, can lead
to a profound diuresis with water and electrolyte depletion. Careful supervision
is required and dosing must be adjusted to individual patients’ needs.
Astramorph PF, Infumorph, Duramorph: Because of the risk of severe adverse
effects when the epidural or intrathecal route of administration is employed,
patients must be observed in a fully equipped and staffed environment
for at least 24 hours after the initial dose.
Patients treated with infliximab are at increased risk for infections,
including progression to serious infections leading to death. These have
included bacterial sepsis, tuberculosis (TB), and invasive fungal, and
other opportunistic infections. Evaluate patient for TB risk factors and
test for latent TB prior to initiating and during therapy.
Do not use promethazine in children younger than 2 years of age because
of the potential for fatal respiratory depression. Use caution when administering
promethazine to children 2 years of age or older by using the lowest effective
dose and avoiding concomitant administration of other drugs with respiratory
depressant effects. For all age groups, IM administration is preferred
and IV administration is discouraged. IV administration should be at a
concentration not to exceed 25 mg/mL and at a rate no greater than 25
mg/min. Avoid subcutaneous and intra-arterial injection because tissue
necrosis and gangrene can result as well as with extravasated IV injections.
Amputations have resulted.
Epoetin alfa (Epogen)
Renal failure: Patients experienced greater risks for death and serious
CV events when administered erythropoiesis-stimulating agents (ESAs) to
target higher vs. lower hemoglobin levels. Individualize dosing to achieve
and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer: ESAs shortened overall survival and/or increased the risk of tumor
progression or recurrence in some clinical studies in patients with breast,
non–small cell lung, head and neck, lymphoid, and cervical cancers.
To decrease these risks use the lowest dose needed to avoid red blood
cell transfusions. Use ESAs only for treatment of anemia caused by concomitant
myelosuppressive chemotherapy. Discontinue following the completion of
a chemotherapy course.
Perisurgery: Epoetin alfa increased the rate of deep venous thromboses
in patients not receiving prophylactic anticoagulation. Consider deep
venous thrombosis prophylaxis.
Ketorolac (inject and oral)
Ketorolac is indicated for the short-term (up to 5 days) management of
moderately severe acute pain that requires analgesia at the opioid level
in adults. It is not indicated for minor or chronic painful conditions.
The resulting NSAID-related adverse reactions can be serious in certain
patients for whom ketorolac is indicated, especially when the drug is
Contraindicated in patients with renal impairment or at risk for renal failure due to
Contraindicated as prophylactic analgesic before any major surgery and is
Contraindicated intra-operatively when hemostasis is critical due to the increased risk
Special populations: For patients >= 65 years of age, for patients less
than 50 kg (110 lbs) of body weight or for patients with moderately elevated
serum creatinine the dose should be adjusted to not exceed 60mg/24hrs.
Haloperidol and Other Anti-Psychotics (Typical and Atypical)
An increased incidence of cerebro-vascular adverse events (including fatalities)
has been reported in elderly patients with dementia-related psychosis.
These drugs are not approved for this indication. When haloperidol is
used to treat delirium, continuous EKG monitoring with specific attention
to a developing QTc interval prolongation is recommended.