Opioids (Butorphanol tartrate NS, Ultram®, Ultram ER®, Ultracet®, Conzip®, codeine containing products, hydrocodone containing cough and cold products)

Exposes patients and others to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur with use. Monitor for respiratory for respiratory depression, especially during initiation or following a dose increase.
Accidental exposure, especially by children, can result in fatal overdose.
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatalogy experts.
Interactions with drugs affecting cytochrome P450 isoenzymes: the concomitant use of butorphanol tartrate NS with all cytochrome P450 3A4 inhibitors may result in an increase in butorphanol plasma concentrations, which could increase or prolong adverse reactions and potentially fatal respiratory depression. Discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in butorphanol concentration. The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol or codeine are complex and requires careful consideration of the effects on the parent drug and the active metabolite.
Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Treximet® (sumatriptan/naproxen):

May cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Treximet® is contraindicated in the setting of coronary artery bypass graft.
NSAID containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

ACE inhibitors (Epaned®, Qbrelis®):

Fetal toxicity. When pregnancy is detected discontinue Epaned®/Qbrelis® as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Benzodiazepines (Clobazem, Halcion®, Doral®, Restoril®, Ativan®, Onfi®, Oxazepam®, Tranxene®, Chlordiazepoxide, Estazolam, Flurazepam and Xanax®):

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and duration to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
The use of benzodiazepines exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing benzodiazepine and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
Abrupt discontinuation or rapid dosage reduction of benzodiazepines after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue the benzodiazepine or reduce the dosage.

Non-Steroidal Anti-Inflammatory Drugs (Naprosyn®, Indocin®)

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
Naprosyn® and Indocin® are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Nortriptyline

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nortriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride is not approved for use in pediatric patients.

Xatmep™ (methotrexate oral solution):

Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression, infection, renal, gastrointestinal, hepatic, pulmonary, hypersensitivity, and dermatologic. Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritic arthritis is contraindicated in pregnancy. Consider the benefits and risks of Xatmep™ and risks to the fetus when prescribing Xatmep™ to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with Xatmep™.

Tegretol® (carbamazepine):

Serious and sometimes fatal dermatologic reactions, including Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported during treatment with Tegretol®. Studies in patients of Chinese ancestry have found a strong association between the risk of developing TEN/SJS and the presence of HLA-b*1502, an inherited allelic variant of the HLA-b gene. HLA-b*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-b*1502 prior to initiating treatment with Tegretol®. Patients testing positive for the allele should not be treated with Tegretol® unless the benefit clearly outweighs the risk.
Aplastic anemia and agranulocytosis have been reported in association with the use of Tegretol®. Data from a population-based case control study demonstrate that the risk of developing these reactions is 5-8 times greater than in the general population. However, the overall risk of these reactions in the untreated general population is low, approximately six patients per one million population per year for agranulocytosis and two patients per one million population per year for aplastic anemia. Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of Tegretol®, data are not available to estimate accurately their incidence or outcome. However, the vast majority of the cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis. Because of the very low incidence of agranulocytosis and aplastic anemia, the vast majority of minor hematologic changes observed in monitoring of patients on Tegretol® are unlikely to signal the occurrence of either abnormality. Nonetheless, complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.

Riomet® [ER] (metformin):

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally > 5 mcg/mL.
Risk factors include renal impairment, concomitant use of certain drugs, age ≥ 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information.
If lactic acidosis is suspected, discontinue Riomet institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Proazac® (fluoxetine)

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
Monitor for worsening and emergence of suicidal thoughts and behaviors.

Qdolo™ (tramadol)

Ensure accuracy when prescribing, dispensing, and administering QDOLO. Dosing errors due to confusion between mg and mL can result in accidental overdose and death
QDOLO exposes users to the risks of addiction, abuse and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing QDOLO, and monitor regularly for these behaviors or conditions.
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially during initiation or following a dose increase.
Accidental ingestion of QDOLO, especially by children, can result in a fatal overdose of tramadol.
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism
QDOLO is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (4). Avoid the use of QDOLO in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
Prolonged use of QDOLO, during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with QDOLO requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1.
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Thyquidity™ (levothyroxine sodium)

Thyroid hormones, including THYQUIDITY, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

Valcyte® (valganciclovir)

Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with VALCYTE.
Impairment of Fertility: Based on animal data and limited human data, VALCYTE may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
Fetal Toxicity: Based on animal data, VALCYTE has the potential to cause birth defects in humans.
Mutagenesis and Carcinogenesis: Based on animal data, VALCYTE has the potential to cause cancers in humans.

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