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CONTRAINDICATION OF NIFEDIPINE
Response to inquiry
While serious adverse reactions requiring discontinuance of nifedipine therapy or dosage
adjustments are uncommon,Ref126284307342 concerns about safety and efficacy of
calcium-channel blocking agents (mainly conventional [short-acting] preparations of
dihydropyridine derivatives) have been raised by findings of several
studies.Ref24024124224324424524624724824925025125225325425525625725825926026
1262263264266344345346347348 Results of a case-control study indicate dose-dependent
increases in the risk of myocardial infarction (by about 60%) in hypertensive patients (with
or without diagnosed cardiovascular disease, but excluding myocardial infarction or heart
failure) receiving a short-acting calcium-channel blocking agent (e.g., nifedipine, diltiazem,
verapamil) compared with those receiving a diuretic or a β-adrenergic blocking
agent.Ref242243244245246247252253254258259261263 In addition, findings of several
pooled analyses of studies indicate an increased risk of mortality (by about 16%) and
reinfarction (by about 19%) in patients who have had a myocardial infarction or in those
with stable or unstable angina who were receiving dihydropyridine-derivative calcium-
2. channel blocking agents (mainly conventional [short-acting] preparations of nifedipine)
compared with those receiving placebo.Ref240242248255266 Results of a pooled analysis of
16 studies indicate that the nifedipine-associated mortality may be dose dependent,
especially in patients receiving short-acting nifedipine dosages of 80 mg or more daily when
compared with those receiving placebo.Ref241242243248249250251254
The National Heart, Lung, and Blood Institute (NHLBI) concluded from the apparent
concordance of findings from observational studies in hypertensive patients and from
randomized studies principally in acute myocardial infarction and unstable angina patients
that it seems prudent and consistent with current evidence to recommend that short-acting
nifedipine, especially at high doses, be used in the management of hypertension, angina, or
myocardial infarction with great caution, if at all.Ref242 In arriving at this conclusion, the
NHLBI recognized the potential biases of observational studies.Ref242 The NHLBI and some
clinicians also state that while other calcium-channel blocking agents (e.g., diltiazem,
verapamil) also were associated with increased risk of myocardial infarction in the described
case-control study, results of previous well-designed clinical studies indicate that the use of
calcium-channel blocking agents was not associated with an increased risk of death;
therefore, the adverse effects associated with short-acting nifedipine may not necessarily
apply to other calcium-channel blocking agents, including other short-acting
dihydropyridines (e.g., isradipine), or to long-acting preparations of
nifedipine.Ref241242243249354 Recent findings of the Antihypertensive and Lipid-Lowering
Treatment to Prevent Heart Attack Trial (ALLHAT), which compared long-term therapy with
an ACE inhibitor (lisinopril) or dihydropyridine-derivative calcium-channel blocker
(amlodipine) revealed no difference in the primary outcome of combined fatal coronary
heart disease or nonfatal myocardial infarction among these therapies.Ref381382415416
The increased risk of myocardial infarction and death in patients receiving short-acting
calcium-channel blocking agents may be associated with the arrhythmogenic, proischemic,
negative inotropic, and/or prohemorrhagic effects of these agents; proischemic effects may
result from reflex increases in sympathetic activity or from a reduction of coronary perfusion
pressure induced by short-acting calcium-channel blocking agents.Ref242248262352
However, some clinicians state that while current evidence indicates an increased relative
risk of myocardial infarction associated with calcium-channel blocking agents, the actual
increased risk for an individual patient may be low.Ref244252258259261 Therefore, patients
should not discontinue such therapy independently,Ref244249253261 but instead should
consult their clinician about possible alternatives based on full evaluation of their medical
condition,Ref244258 since the known risks of uncontrolled hypertension may be far greater
than the postulated but unproven hazards associated with calcium-channel blocking
agents.Ref247258
Cardiovascular Effects
Serious adverse reactions requiring discontinuance of nifedipine therapy or dosage
adjustment are relatively rare.Ref284 An increase in the frequency, intensity, and duration
of angina, possibly resulting from hypotension, has occurred rarely during initiation of
nifedipine therapy.Ref284 Additional serious adverse effects including myocardial infarction,
3. congestive heart failure or pulmonary edema, and ventricular arrhythmia or conduction
defects have reportedly occurred in 4%, 2%, and less than 0.5% of patients receiving
conventional nifedipine capsules, respectively, but these have not been directly attributed to
the drug.Ref284 For additional information on potential serious cardiovascular effects
associated with nifedipine, see the introductory discussion in Cautions and see also
Cautions: Precautions and Contraindications.
Chest pain (nonspecific) has been reported in less than 3% of patients receiving extendedrelease nifedipine tablets in clinical trials.Ref126 Adverse cardiovascular effects reported in
up to 1% of patients receiving extended-release nifedipine tablets include substernal chest
pain,Ref342 arrhythmia,Ref126 atrial fibrillation,Ref342 bradycardia,Ref342
tachycardia,Ref126342 cardiac arrest,Ref342 extrasystole,Ref342 hypotension,Ref126342
postural hypotension,Ref342 syncope,Ref126 increased angina,Ref126 phlebitis,Ref342 and
cutaneous angiectases.Ref342
Most of the common adverse reactions to nifedipine result from its vasodilating action on
vascular smooth muscle and include dizziness, lightheadedness, giddiness, flushing or heat
sensation, and headache, reportedly occurring in up to 25% of patients, and less frequently,
hypotension (usually mild to moderate and well tolerated), weakness, peripheral edema,
and palpitation.Ref284 The incidence and severity of syncope, peripheral (ankle) edema, and
hypotension generally are dose related and occasionally may be obviated by a reduction in
dosage.Ref284 In patients receiving conventional liquid-filled (short-acting) nifedipine
capsules, transient hypotension occurred in about 2% of patients receiving less than 60 mg
daily and in about 5% of patients receiving 120 mg or more daily.Ref284 Nifedipine-induced
peripheral edema of the lower extremities usually responds to diuretic therapy.Ref284 The
relatively common adverse effects reported with conventional liquid-filled (short-acting)
nifedipine capsules are similar in nature to those reported with extended-release tablets of
the drug.Ref126 However, some evidence indicates that the risk of certain adverse effects
may be increased with short-acting preparations of the drug, particularly at high
doses.Ref240241242243244245246247248249250251252253254255256257258259260261
262263264266(See the introductory discussion in Cautions.)
Although the hypotensive effect of nifedipine is modest and well tolerated in most patients
receiving the drug for angina, excessive and poorly tolerated hypotension occurs
occasionally in such patients.Ref126284286307 Such excessive hypotension usually occurs
during initial dosage titration or subsequent upward titration of dosage, and may be more
likely in patients receiving a β-adrenergic blocking agent
concomitantly.Ref126129284286307 Severe hypotension and/or increased fluid
requirements also have been reported in patients who were receiving these drugs
concomitantly and underwent coronary artery bypass surgery involving high-dose fentanyl
anesthesia.Ref126129284307342(See Drug Interactions: Fentanyl.) Several cases of
profound hypotension, cerebrovascular ischemia or stroke, myocardial ischemia or
infarction, and/or death have been reported when conventional short-acting preparations of
nifedipine were used for the management of hypertensive
crises,Ref119283284288295300302303304307308 and therefore, the manufacturers
currently warn that short-acting preparations should not be used for acute reduction in
4. blood pressure.Ref284307(See Hypertensive Crises under Uses: Hypertension.) However,
profound hypotension, myocardial ischemia or infarction, and/or death also have been
reported occasionally in patients receiving conventional short-acting preparations of the
drug for other uses (e.g., angina, pulmonary hypertension).Ref283286287310 The
manufacturers also warn that short-acting preparations of nifedipine should not be used for
the chronic management of hypertension.Ref284307
The frequency of nifedipine-induced peripheral edema appears to be dose related and
reportedly occurs in 10–30% of patients receiving the drug.Ref126 The edema is localized
and probably occurs secondary to vasodilation of dependent arterioles and small blood
vessels rather than to left ventricular dysfunction or generalized fluid
retention.Ref126284307342 Intolerable adverse effects associated with nifedipine-induced
vasodilation (e.g., headache, flushing, orthostatic hypotension) may limit the usefulness of
nifedipine in some patients receiving the drug for Raynaud’s
phenomenon.Ref144146147148151158160297305306 The extended-release preparations
of nifedipine appear to be tolerated better than the short-acting preparation in patients with
this condition.Ref297305306 The principal troublesome adverse effect during long-term
therapy in these patients appears to be peripheral (ankle) edema.Ref297
Erythromelalgia has been reported in about 0.5% of patients receiving
nifedipine.Ref284307331 Characteristic manifestations of erythromelalgia include burning
pain, increased skin temperature, and erythema of the extremities, usually the feet and
lower legs, and less commonly, the hands.Ref331 Manifestations resolve following
discontinuance of the drug.Ref331
Nervous System Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, weakness
was reported in 12% of patients, while tremor, nervousness, and mood changes occurred in
about 7–8% of patients; fever and chills were reported in up to 2% of patients, and
shakiness, jitteriness, disturbed sleep, and difficulty with postural balance occurred
occasionally; mental depression and paranoid syndrome were reported rarely. Ref284 In
patients receiving extended-release nifedipine tablets, fatigue and asthenia were reported in
about 4–6% of patients,Ref126342 pain occurred in less than 3% of patients,Ref126342 and
paresthesia, vertigo, asthenia, insomnia, nervousness, and somnolence were reported in up
to 3% of patients, while migraine,Ref126342 anxiety,Ref126342 confusion,Ref342
ataxia,Ref126 depression,Ref126342 hypertonia,Ref126342 hypoesthesia,Ref126342
paroniria,Ref126 fever,Ref126342 and tremorRef126 were reported in up to 1% of
patients.Ref126342 Chills occurred in less than 1% of patients.Ref342For nervous system
effects associated with the vasodilating effect of nifedipine, see Cautions: Cardiovascular
Effects.
GI Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, nausea and
heartburn occurred in 11% of patients, while diarrhea, constipation, cramps, and flatulence
were reported occasionally, and gingival hyperplasia occurred rarely.Ref284 In patients
5. receiving extended-release nifedipine tablets, nausea and constipation were reported in
about 2–3 and about 1–3%, respectively, while abdominal pain, diarrhea, dry mouth,
dyspepsia, and flatulence occurred in less than 3% of patients,Ref126342 and
dysphagia,Ref342 eructation,Ref126342 gastroesophageal reflux,Ref126 esophagitis,Ref342
vomiting,Ref126342 melena,Ref126 GI hemorrhage,Ref342 gum hemorrhage,Ref342 gum
hyperplasia,Ref126 gum disorder,Ref342 unspecified GI disorder,Ref342 and taste
perversionRef126 were reported in up to 1% of patients. GI irritation and GI bleeding have
been reported in less than 1% of patients receiving Procardia XL® extended-release
nifedipine tablets in open-label trials and during post-marketing experience, although a
causal relationship to the drug has not been established.Ref126
Symptoms of GI obstruction have occurred in several patients with a history of GI strictures
who were receiving extended-release tablets of the drug.Ref126(See Cautions: Precautions
and Contraindications.) GI obstruction also has occurred in at least one patient with no
preexisting abnormality who was receiving conventional capsules of the drug concomitantly
with diltiazem; it was suggested that obstruction in this patient may have resulted from a
pharmacologic effect on intestinal smooth muscle.Ref235
Dermatologic and Sensitivity Reactions
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, dermatitis,
pruritus, urticaria, and sweating have been reported occasionally, Ref284 while angioedema
(principally oropharyngeal edema and occasionally breathing difficulty) occurred in less than
0.5% of patients.Ref284307 Exfoliative dermatitis, exfoliative or bullous skin reactions
(including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal
necrolysis), and photosensitivity reactions have been reported rarely.Ref284
In patients receiving extended-release nifedipine tablets, rash and pruritus have been
reported in up to 3% of patients,Ref126342 while angioedema,Ref342 allergic
reaction,Ref342 cellulitis,Ref342 facial edema,Ref126342 periorbital edema,Ref126
alopecia,Ref126342 sweating,Ref126342 urticaria,Ref126 photosensitivity reactions,Ref342
and petechial rashRef342 were reported in up to 1% of patients.
Anaphylactic reactions have been reported rarely in patients receiving nifedipine.Ref342
Respiratory Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, dyspnea,
cough, wheezing, nasal congestion, and sore throat occurred in 6% of of patients,
whileRef284 chest congestion and shortness of breath have been reported in up to 2% of
patients.Ref284
In patients receiving extended-release nifedipine tablets, dyspnea, epistaxis, and rhinitis
were reported in up to 3% of patients, Ref126342 while cough,Ref126342
pharyngitis,Ref342 sinusitis,Ref126 upper respiratory tract infection,Ref126 respiratory
disorder,Ref126 rales,Ref342 and stridorRef342 were reported in up to 1% of patients.
Musculoskeletal Effects
6. In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, muscle
cramps occurred in 8% of patients, while musculoskeletal complaints of inflammation and
joint stiffness have been reported occasionally, and myalgia and arthritis with increased
antinuclear antibodies (ANA) have been reported rarely.Ref284
In patients receiving extended-release nifedipine tablets, arthralgia,Ref126342 leg
pain,Ref342 and leg crampsRef126342 occurred in up to 3% of patients, while
myalgia,Ref126342 arthritis,Ref342 joint disorder,Ref342 myasthenia,Ref342 back
pain,Ref126 neck pain,Ref342 and goutRef126 occurred in up to 1% of patients.
Genitourinary Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, sexual
difficulty has been reported occasionally, while gynecomastia, nocturia, and polyuria have
been reported rarely.Ref284
In patients receiving extended-release nifedipine tablets, impotence,Ref126342
polyuria,Ref126342 and urinary frequencyRef342 have been reported in up to 3% of
patients, while decreased libido,Ref126342 breast pain,Ref126 pelvic pain,Ref342
dysuria,Ref126342 hematuria,Ref126 and nocturiaRef126342 occurred in up to 1% of
patients, and renal calculi, urogenital disorder, and breast engorgement were reported in
less than 1% of patients.Ref342 Gynecomastia has been reported in less than 1% of patients
receiving Procardia XL® extended-release nifedipine tablets in open-label trials and during
postmarketing experience, although a causal relationship to the drug has not been
established.Ref126
Hepatic Effects
Abnormal laboratory test results including mild to moderately increased serum
concentrations of alkaline phosphatase, LDH, creatine kinase (CK, creatine phosphokinase,
CPK), AST (SGOT), and ALT (SGPT) have been reported rarely in patients receiving
nifedipine.Ref126284342 Although a definite causal relationship of these laboratory test
results to the drug has not been established, the relationship has been considered probable
in several cases. Ref126284342 In most cases, the laboratory test abnormalities were not
associated with clinical symptoms; however, cholestasis (with or without jaundice) has been
reported.Ref126284342 Small increases (about 5%) in mean alkaline phosphatase
concentrations have been reported in patients receiving extended-release nifedipine tablets;
however, these increases were clinically asymptomatic, isolated incidents that rarely
resulted in values outside the normal range.Ref126342 Increased γ-glutamyltransferase
(GGT, γ-glutamyltranspeptidase, GGTP) concentrations have been reported in less than 1%
of patients receiving Adalat® CC extended-release nifedipine tablets.Ref342 Allergic hepatitis
has occurred rarely.Ref126284342
Renal Effects
In patients with preexisting chronic renal insufficiency receiving nifedipine, reversible
increases in blood urea nitrogen (BUN) and serum creatinine concentrations have been
reported rarely.Ref126284342 Although a definite causal relationship of these laboratory
7. test results to the drug has not been established, the relationship has been considered
probable in several cases.Ref126284342
Ocular and Otic Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules, blurred
vision has been reported occasionally,Ref284 while transient blindness at peak serum
nifedipine concentrations and transient unilateral loss of vision have been reported
rarely.Ref284
In patients receiving extended-release nifedipine tablets, abnormal lacrimationRef126 and
vision abnormalitiesRef126342 have been reported in up to 1% of patients, while amblyopia,
conjunctivitis, diplopia, eye disorder, and ocular hemorrhage have been reported in less
than 1% of patients.Ref342
Tinnitus has been reported in up to 1% of patients receiving nifedipine.Ref342
Hematologic Effects
In patients receiving conventional liquid-filled (short-acting) nifedipine capsules,
thrombocytopenia, anemia, leukopenia, and purpura have been reported rarely.Ref284 In
patients receiving extended-release nifedipine tablets, purpura occurred in up to 1% of
patients,Ref126342 and eosinophilia and lymphadenopathy occurred in less than 1% of
patients.Ref342 Positive antiglobulin (Coombs’) test results, with or without hemolytic
anemia, have been reported in patients receiving nifedipine, but a causal relationship to the
drug has not been established.Ref126284307342
Like other calcium-channel blocking agents, nifedipine decreases platelet aggregation in
vitro.Ref126284342 A moderate decrease in platelet aggregation and increases in bleeding
time, believed to be related to inhibition of calcium transport across the platelet membrane,
have been reported in patients receiving nifedipine in a limited number of clinical studies;
however, these findings were not considered to be clinically important.Ref126284342
Metabolic Effects
Weight gain has been reported in up to 1% of patients receiving Procardia XL® extendedrelease nifedipine tablets,Ref126 while weight loss has been reported in less than 1% of
patients receiving Adalat® CC extended-release nifedipine tablets.Ref342
Other Adverse Effects
In patients receiving extended-release nifedipine tablets, hot flushes (flashes),Ref126
rigors,Ref126 and malaiseRef126342 were reported in up to 1% of patients in clinical trials.
Precautions and Contraindications
Some findings concerning possible risks of calcium-channel blocking agents have raised
concerns about the safety and efficacy of these agents (mainly conventional [short-acting]
preparations of
8. nifedipine).Ref24024124224324424524624724824925025125225325425525625725825926
0261262263264266352 However, recent findings with amlodipine in the ALLHAT study have
shown a beneficial effect of dihydropyridine-derivative calcium-channel blockers on fatal
coronary heart disease and nonfatal myocardial infarction in patients treated with the drug
for hypertension.Ref381382415416 In addition, post hoc analysis of the ALLHAT study
directly comparing patients receiving a calcium-channel blocking agent (amlodipine) or an
ACE inhibitor (lisinopril) has shown that patients receiving the ACE inhibitor experienced
higher risks of stroke, combined cardiovascular disease, GI bleeding, and angioedema, while
the risk of developing heart failure was higher in those receiving the calcium-channel
blocking agent.Ref417418
Whether the adverse cardiovascular and mortality effects associated with short-acting
nifedipine apply to other calcium-channel blocking agents, including other short-acting
dihydropyridine derivatives (e.g., isradipine), or to extended-release preparations or innately
slow-acting blockers remains to be established.Ref242352 For additional information on
possible risks, see the introductory discussion in Cautions and also the section on
Cardiovascular Effects as well as Uses: Other Uses.
Nifedipine shares the toxic potentials of the calcium-channel blocking agents, and the usual
precautions of these agents should be observed.
Because nifedipine decreases peripheral vascular resistance and occasionally causes
excessive and poorly tolerated hypotension, blood pressure should be monitored carefully,
especially during initiation of therapy and titration or upward adjustment of dosage. In
addition, the manufacturers warn that the frequency, duration, and severity of angina may
increase during initiation of therapy or upward adjustment of dosage.
Nifedipine should be used with caution in patients with congestive heart failure or aortic
stenosis, especially in those receiving concomitant β-adrenergic blocking agents, because
nifedipine may precipitate or worsen heart failure in these patients. Peripheral edema
occurring during the course of nifedipine therapy should be investigated, especially in
patients with congestive heart failure, since it may indicate deterioration in left ventricular
function induced by the drug.
When nifedipine therapy is initiated in patients with angina, they should be warned that the
drug may cause increased angina, especially if β-adrenergic blocker therapy is withdrawn
abruptly when nifedipine therapy is being initiated. (See Drug Interactions: β-Adrenergic
Blocking Agents.)
As with other nondeformable material, extended-release nifedipine tablets should be used
with caution in patients with underlying severe GI narrowing (pathologic or iatrogenic) since
obstruction may occur.Ref126
Nifedipine is contraindicated in patients with known hypersensitivity to the
drug.Ref126284342
Pediatric Precautions
9. Although safety and efficacy remain to be fully established in children younger than 18 years
of age,Ref126284 some experts have recommended pediatric dosages for hypertension
based on currently limited clinical experience.Ref395For information on overall principles for
treatment of hypertension and overall expert recommendations for such disease in pediatric
patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement
40:28.20.
Geriatric Precautions
Although a prolonged elimination half-life and an increase in peak plasma concentration and
area under the plasma concentration-time curve (AUC) have been observed in
pharmacokinetic studies in small numbers of patients (see Pharmacokinetics: Elimination),
clinical studies of nifedipine did not include sufficient numbers of patients 65 years of age
and older to determine whether geriatric patients respond differently than younger
adults.Ref284342 While other clinical experience generally has not revealed age-related
differences in response or tolerance, drug dosage generally should be titrated carefully in
geriatric patients, usually initiating therapy at the low end of the dosage range and adjusting
dosage as necessary based on patient response.Ref284342 The greater frequency of
decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug
therapy observed in the elderly also should be considered.Ref284342
Mutagenicity and Carcinogenicity
In vivo studies using nifedipine have not revealed evidence of mutagenicity.Ref126284342
No evidence of carcinogenicity was observed in rats receiving oral nifedipine for 2
years.Ref126284342
Pregnancy, Fertility, and Lactation
Pregnancy
Nifedipine has been shown to be teratogenic in rats and rabbits.Ref126284 Digital anomalies
similar to those reported with phenytoin also have been reported in the offspring of animals
receiving nifedipine or other dihydropyridines; these anomalies may occur secondary to
compromised uterine blood flow.Ref126284307 Nifedipine administration in rats, mice,
rabbits, and monkeys also has been associated with a variety of other embryotoxic,
placentotoxic, and fetotoxic effects, including stunted fetuses (rats, mice, and rabbits), rib
deformities (mice), cleft palate (mice), small placentas and underdeveloped chorionic villi
(monkeys), embryonic and fetal deaths (rats, mice, and rabbits), and prolonged
pregnancy/decreased neonatal survival (rats; not evaluated in other
species).Ref126284307342 The dosages (on a mg/kg basis) of nifedipine associated with
teratogenic, embryotoxic, or fetotoxic effects in animals were higher (3.5–42 times) than the
maximum recommended human dosage (120 mg daily);Ref126284 however, such dosages
were within one order of magnitude of the maximum recommended human
dosage.Ref126284342 The dosages of nifedipine associated with placentotoxic effects in
monkeys were equivalent to or lower than the maximum recommended human dosage on a
mg/m2 basis.Ref126284 There are no adequate and well-controlled studies using nifedipine
10. in pregnant women, and the drug should be used during pregnancy only when the potential
benefits justify the possible risks to the fetus.Ref126284342
Fertility
Nifedipine caused decreased fertility when given to rats prior to mating at a dosage
approximately 30 times the maximum recommended human dosage.Ref126284342 A
reversible reduction in the ability of human sperm to bind to and fertilize an ovum in vitro
has been reported in a limited number of infertile men who were receiving usual dosages of
nifedipine when the sperm was obtained.Ref126284307342
Lactation
Nifedipine is distributed into milk.Ref165342 In one lactating woman who received 10, 20,
and 30 mg of the drug every 8 hours as conventional capsules, peak milk concentrations of
nifedipine occurred within 1 hour after a dose and ranged from about 13–53 ng/mL; the
drug generally was not detectable during the hour prior to a dose.Ref165 Because of the
potential for serious adverse reactions to nifedipine in nursing infants, a decision should be
made whether to discontinue nursing or the drug, taking into account the importance of the
drug to the woman.Ref
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