THC oil 0.5 grams
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Below is general information about the effectiveness of the known ingredients contained in the product Rick Simpson Hemp Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Rick Simpson Hemp Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY UNSAFE ...when THC is used orally or inhaled in large amounts or for an extended duration. Edible cannabis products containing at least 50 mg of THC have been associated with cases of anxiety, psychosis, myocardial infarction, and ventricular arrhythmia (103796). In addition, e-cigarette, or vaping, product-use associated lung injury (EVALI) is thought to be associated with THC. EVALI has occurred among adults and children who use these products. The majority of patients with EVALI reported using THC-containing products in the 3 months prior to the development of symptoms (101421). Although it is possible that other ingredients, such as vitamin E acetate, may be involved in these cases of lung injury, the US Food and Drug Administration (FDA) has warned the public to stop using all THC-containing vaping products due to the risk for EVALI (101429). Use of cannabis containing THC has also been associated with seizures, cognitive impairment, and mood disturbances. Cessation of cannabis containing THC may precipitate cannabis withdrawal syndrome, the severity of which depends on the frequency and quantity of use prior to cessation (61896,91909,96378,96381,99588,99576,99580,102801). Excessive and prolonged use of cannabis containing THC, either by smoking and/or oral use, can lead to cannabinoid hyperemesis syndrome (CHS). This condition is characterized by severe, repeat bouts of nausea and vomiting that cannot be alleviated by conventional antiemetics (99585,99577). In several cases, CHS has been linked to severe complications resulting in death (99585). THC likely plays a role in these adverse effects; however, it is also possible that other constituents are involved. A meta-analysis of clinical research involving adults with a mean age of at least 50 years shows that increasing the dose of natural or synthetic THC in cannabinoid-based medicines is associated with a modest increase in overall adverse effects, but not with serious adverse effects or death (105559). A meta-analysis of lower quality clinical and observational research suggests that the incidence rate of adverse effects related to use of natural or synthetic THC in cannabinoid-based medicines is low, and serious adverse events are lacking (110257).
PREGNANCY: UNSAFE
when used orally or inhaled.
Cannabinoid constituents in cannabis, such as THC, pass through the placenta and can reduce fetal growth and increase the risk for preterm birth (101425,101481,103792,104490). Cannabis use during pregnancy is also associated with placental abruption, stillbirth, preterm delivery, fetal abnormalities, low birth weight, small for gestational age, increased need for neonatal intensive care, and childhood leukemia (4260,25162,61855,96380,101425,101481,101483,108699). Prenatal cannabis use has also been associated with long-term adverse developmental effects in the offspring, such as worsened cognition, increased risk for neurodevelopmental disorders such as autism spectrum disorder, and increased risk for psychological issues during adolescence (103792,104485). Due to the observational nature of these studies, it is unclear if cannabis causes these adverse effects. Umbilical artery Doppler scans also show that cannabis use can increase placental vascular resistance (101483). Cannabis use during pregnancy has been associated with increased risk of anemia and hypertension in the mother (96380,101481). Although the safety of pure THC has not been investigated during pregnancy, it is likely that THC is at least partially responsible for these safety concerns.
The rate of negative fetal outcomes due to cannabis use during pregnancy may have been previously underestimated due to reliance on maternal self-reporting of use. Recent programs requiring maternal urine toxicology testing have increased awareness of maternal cannabis use and suggest that negative fetal outcomes occur more frequently than previously recorded (101481,101482).
LACTATION: LIKELY UNSAFE
when used orally or inhaled.
THC is concentrated and excreted in breast milk for longer than 6 weeks after cessation of use (2619,2620,104894); prolonged use of cannabis containing THC during lactation has been associated with delayed motor development (25163). Observational research in mothers who successfully abstained from cannabis use for 6 weeks (confirmed by a negative THC urine screen) after smoking cannabis prenatally at least twice weekly, found that THC levels in breastmilk increased during the first 2 weeks of abstinence and then decreased but remained detectable at 6 weeks (104894). For patients planning to breastfeed, recommend abstaining from THC use prenatally and during lactation. Recommendations to discard breastmilk until THC levels are undetectable are not practical, as this may take more than 6 weeks.
Below is general information about the interactions of the known ingredients contained in the product Rick Simpson Hemp Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, THC might have additive effects when used with alcohol.
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THC can have CNS depressant effects. Theoretically, concomitant use of alcohol with THC can have additive effects including psychomotor impairment, sedation, and changes in mood and behavior (2619).
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THC use might alter the safety and clinical effects of various forms of anesthesia.
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Cannabis contains THC. A small clinical study shows that higher doses of propofol may be needed to achieve relaxation and loss of consciousness in chronic cannabis users compared with nonusers (96378). Another small clinical study shows that use of cannabis within 72 hours prior to undergoing surgery requiring atropine anesthesia may increase the risk of sustained postoperative tachycardia (95727). The exact mechanisms of these interactions are unclear. Obtain a patient's history of cannabis use preoperatively and advise patients to discontinue use for at least 2 weeks prior to undergoing surgery.
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Theoretically, THC might increase the risk of bleeding when used concomitantly with anticoagulant/antiplatelet drugs.
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Theoretically, THC might increase the levels and adverse effects of barbiturates.
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Theoretically, THC might have additive effects if used with other CNS depressants.
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Theoretically, drugs that are CYP2C9 inducers might decrease the levels and clinical effects of THC.
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THC is a substrate of CYP2C9 enzymes (99747).
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Theoretically, drugs that are CYP2C9 inhibitors might increase the levels and adverse effects of THC.
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THC is a substrate of CYP2C9 enzymes (99747).
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Theoretically, THC might increase the levels and adverse effects of CYP2C9 substrates.
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In vitro research shows that THC moderately inhibits the CYP2C9-mediated 7-hydroxylation of S-warfarin in a concentration-dependent manner (99578). Theoretically, THC may inhibit the metabolism of other CYP2C9 substrates.
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Theoretically, THC might decrease the levels and clinical effects of CYP2E1 substrates.
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In vitro research shows that cannabis containing THC can induce the activity of CYP2E1, which might increase the metabolism of CYP2E1 substrates (61726). It is unclear if this effect is due to THC, other constituents, or the combination.
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Theoretically, CYP3A4 inducers might reduce the levels and clinical effects of THC.
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THC is a substrate of CYP3A4 enzymes (99747).
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Theoretically, CYP3A4 inhibitors might increase the levels and clinical effects of THC.
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THC is a substrate of CYP3A4 enzymes (99747).
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Theoretically, THC may increase the levels and clinical effects of CYP3A4 substrates.
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In vitro research shows that cannabis containing THC can inhibit the activity of CYP3A4 enzymes, which might decrease the metabolism of CYP3A4 substrates (25160). It is unclear if this effect is due to THC, other constituents, or the combination.
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Theoretically, THC might alter levels of drugs that are substrates of P-glycoprotein (P-gp).
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Most in vitro research suggests that THC can inhibit P-gp and increase the accumulation of probe compounds by reducing P-gp mediated drug efflux. In vitro studies in kidney cell lines show that a 1-hour exposure to CBD and THC inhibits P-gp (61769,104889). THC may also alter the expression of P-gp, although this effect appears to vary based on duration of exposure. Some in vitro research in lymphoblastoid leukemia cell lines indicates that a 1-hour exposure to cannabinoids does not affect P-gp expression, while a prolonged 72-hour exposure decreases P-gp expression (61771). Other in vitro research in these cell lines shows that a 4-hour exposure to THC and CBD induces P-gp gene expression, while exposure for longer than 4 hours and up to 48 hours does not induce P-gp gene expression (104893).
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Theoretically, THC might reduce the levels and clinical effects of theophylline.
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Smoking cannabis containing THC seems to increase the metabolism of theophylline (16815). It is unclear if this effect is due to THC, other constituents, or the combination.
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THC might augment the effects of thrombolytic drugs and increase the risk of severe bleeding.
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Cannabis contains THC. A case of cerebral hemorrhage has been reported for a 51-year-old female and chronic cannabis user who had consumed a large amount of cannabis prior to receiving recombinant tissue plasminogen activator (rtPA) for ischemic stroke. Hemorrhage had been ruled out prior to providing the rtPA. The exact mechanism of this interaction is unclear (96799). It is also unclear if this effect is due to THC, other constituents, or the combination.
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Concomitant use with THC seems to increase the levels and clinical effects of warfarin.
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In vitro research shows that the cannabinoids THC, cannabidiol (CBD), and cannabinol inhibit the cytochrome P450 2C9 (CYP2C9)-mediated 7-hydroxylation of S-warfarin in a concentration-dependent manner. There are also three case reports of patients chronically taking warfarin that developed a spike in international normalized ratio (INR) after smoking cannabis or taking medical cannabis orally. Although the dose of THC consumed in all cases is unknown, one of the patients doubled the amount of THC consumed from 7.5 mg to 14.7 mg daily for one week (16832,99578,104483).
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Below is general information about the adverse effects of the known ingredients contained in the product Rick Simpson Hemp Oil. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...There is limited reliable information available about the adverse effects associated with pure THC.
When inhaled or used orally, cannabis can cause various adverse effects, many of which are thought to be related to THC. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Most Common Adverse Effects:
All ROAs: When cannabis containing THC is used, dizziness, dry mouth, fatigue, headache, increased appetite, nausea, paranoid and dissociative thinking, and sedation have occurred. Intoxicating doses can impair declarative memory, motor coordination, reaction time, and visual perceptions for up to 8 hours. It is unclear if these adverse effects are due to THC, other constituents, or a combination.
Serious Adverse Effects (Rare):
All ROAs: When higher doses of cannabis containing THC are used, acute coronary syndrome, arrhythmias, blood pressure changes, cannabinoid hyperemesis syndrome (CHS), hallucinations, pancreatitis, panic, psychosis, and seizures have occurred. It is unclear if these adverse effects are due to THC, other constituents, or a combination.
Cardiovascular
...Orally, edible cannabis products containing 50 mg or more of THC have been associated with myocardial infarction and ventricular arrhythmia (103796).
In a case report, a 2-year-old boy developed bradycardia with first-degree atrioventricular block which lasted 12 hours, after accidentally consuming an unknown number of cannabis gummies containing THC (110237). Additionally, taking a prescription drug called dronabinol (Marinol) or nabilone (Cesamet), a synthetic form of THC, has been associated with hypotension, hypertension, syncope and/or tachycardia (110258,110259).
There is case report of pericardial effusion suspected to be related to vaping cannabis 1.5 mg daily, providing 95% THC, for two months. However, the presence of contaminants in the product could not be ruled out. Treatment included aspirin 325 mg every 8 hours, colchicine 0.5 mg every 12 hours, and pantoprazole 40 mg every 12 hours (110231).
Cannabis containing THC has also been associated with other cardiovascular adverse effects, including increased blood pressure, increased heart rate, arrhythmia, acute coronary syndrome, myocardial infarction, and stroke. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Dermatologic
...Cannabis containing THC has been associated with dermatologic adverse effects, including erythema multiforme-like recurrent drug eruption.
However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Taking a prescription drug called dronabinol (Marinol), a synthetic form of THC, has been associated with hypersensitivity reactions, including skin hives, rash, or flushing (110258).
Endocrine ...Cannabis containing THC has been associated with endocrine adverse effects, including weight gain, worsened glycemic control, and acute pancreatitis. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Gastrointestinal
...Meta-analyses of clinical and observational research involving adults with a mean age of at least 50 years shows that increasing the dose of natural or synthetic THC in cannabinoid-based medicines is associated with a modest increase in the rate of dry mouth, nausea, and vomiting (105559,110257).
Dry mouth has also been reported in clinical research (110249). In addition, taking a prescription drug called dronabinol (Marinol) or nabilone (Cesamet), synthetic forms of THC, has been associated with abdominal pain (110258,110259).
Cannabis containing THC has been associated with other gastrointestinal adverse effects, including cannabinoid hyperemesis syndrome (CHS). However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph. Taking a prescription drug called nabilone (Cesamet) 2 mg, a synthetic compound similar to THC, for 7 weeks exacerbated nausea and vomiting in a patient with cancer. CHS was suspected. Symptoms did not recur after the nabilone was stopped. The patient had been using nabilone 0.5 mg for 5 years to control neuralgia; however, the dose had been increased to 2 mg to help with cancer pain (110239).
Genitourinary
...A meta-analysis of clinical research involving adults with a mean age of at least 50 years shows that increasing the dose of natural or synthetic THC in cannabinoid-based medicines is associated with a modest increase in the rate of male impotence (105559).
Cannabis containing THC has been associated with other genitourinary adverse effects, including priapism and abnormal menstruation. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Hematologic ...Cannabis containing THC has been associated with hematologic adverse effects, including hemorrhage. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Immunologic ...Taking a prescription drug called dronabinol (Marinol), a synthetic form of THC, has been associated with hypersensitivity reactions, including lip swelling and oral lesions, skin hives, rash, or flushing, or throat tightness (110258). A meta-analysis of lower quality clinical and observational research suggests that the use of natural or synthetic THC in cannabinoid-based medicines is associated with a slight increase in respiratory and urinary tract infections (110257).
Musculoskeletal ...Cannabis containing THC has been associated with musculoskeletal adverse effects, including hypotonia. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Neurologic/CNS
...Meta-analyses of clinical and observational research involving adults with a mean age of at least 50 years shows that increasing the dose of natural or synthetic THC in cannabinoid-based medicines is associated with a modest increase in overall adverse effects, including dizziness/light-headedness, mobility/balance/coordination difficulties, somnolence, disorientation, memory impairment, fatigue, and euphoria (105559,110257).
Euphoria has also been reported in clinical research (110249).
Intoxicating doses of THC-containing cannabis impair reaction time, motor coordination, declarative memory, and visual perceptions, and can also produce panic reactions and other emotional disturbances. An individual's driving ability can be impaired for up to 8 hours (18,61896,103023). A small prospective study has found that inhaling vaporized cannabis containing THC 13.75 mg or THC/cannabidiol 13.75 mg increases lane weaving for the first 100 minutes when compared with placebo. This impairment was comparable to that of a blood alcohol concentration of 0.05%, which is considered to indicate clinically relevant impairment (104482). The validity of this finding is limited because the study only tested a single dose of cannabis, which does not mimic typical real-world use (104484). Acute use of cannabis has also been associated with increased motor collision risk (61911,61904), especially if the driver is using alcohol or other drugs concomitantly (103024). Two retrospective studies have found that state-based legalization and commercialization of cannabis is associated with increased traffic fatalities (103022,103024,103027). These studies are limited due to their retrospective nature and a lack of control over other confounding factors such as out-of-state cannabis tourism that could have affected driving fatalities. It is unclear if these adverse effects are due to THC, other constituents, or a combination.
Cannabis containing THC has also been associated with other neurologic adverse effects, including headache, disorientation, cognitive impairment, and fatigue. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Ocular/Otic
...A meta-analysis of clinical research involving adults with a mean age of at least 50 years shows that increasing the dose of natural or synthetic THC in cannabinoid-based medicines is associated with a modest increase in overall adverse effects, including visual symptoms (105559).
Cannabis containing THC has been associated with other ocular or otic adverse effects, including dry eye, reddening of the eyes, and tinnitus. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.
Oncologic ...There is some concern that use of cannabis containing THC increases the risk for cancer. A meta-analysis of observational case-control studies found that cannabis is not associated with an increased risk for head and neck squamous cell carcinoma or oral cancer. However, more than 10 years of cannabis use is associated with an increased risk for testicular germ cell tumor (101430). It is unclear if this is due to THC, other constituents, or a combination.
Psychiatric
...Cannabinoids such as THC can increase anxiety, confusion, depressed mood, and hallucinations, and reduce motivation (96384,110252,110257).
Cannabis dabbing, the making of a waxy product with extremely high concentrations of THC, is thought to increase the risk of anxiety, agitation, paranoia, and psychosis (108341). When consumed in large amounts, edible cannabis products containing at least 50 mg of THC have been associated with anxiety, abnormal behavior, psychosis, and suicidal tendencies (91914,103796).
A case of erratic speech and hostile behaviors, followed by suicidal actions resulting in death, has been reported in a 19-year-old male who consumed an edible cannabis cookie. According to the product label, the serving size should have been one-sixth of the cookie, or 10 mg of THC. However, the patient ate the entire cookie after not experiencing effects within 30-60 minutes of the initial dose (91914). Due to this case and other cases of overconsumption of edible cannabis products, in February 2015 the state of Colorado began requiring that edible cannabis products contain no more than 10 mg of THC per serving or that the products have clear demarcation of each 10 mg serving if they contain more than 10 mg of THC (91914).
One small clinical trial shows that inhaling vaporized cannabis containing THC 10 mg, alone or with cannabidiol (CBD) 10-30 mg, modestly induces psychotic symptoms (110242). Also, a single dose of inhaled cannabis providing THC 13.75 mg and < 1% CBD increases feelings of anxiety when compared to cannabis providing CBD 13.75 mg and <1% THC (110254).
Use of cannabis containing THC can be habit-forming. Meta-analyses of the available research suggest that as many as 47% of regular cannabis users develop some form of dependence, and up to 9% of all users develop cannabis use disorder (101701,102801). In patients with cannabis dependence, cessation of use can precipitate cannabis withdrawal within 1-2 days. The risk for cannabis withdrawal syndrome seems to be greater in males, those with higher cannabis use, and those with concomitant drug or tobacco use (102801). Symptoms of cannabis use withdrawal typically last for 7-14 days and include irritability, nervousness, difficulty sleeping, decreased appetite, and depressed mood. Physical symptoms such as stomach pain, tremors, sweating, fever, or headache might also occur. Severity of withdrawal varies, and largely depends on the cumulative amount of cannabis used prior to cessation (99576,101702). Withdrawal symptoms may be particularly problematic in individuals with pre-existing depression or anxiety, resulting in failed cessation attempts (102801).
Cannabis containing THC has also been associated with other psychiatric adverse effects, including anxiety, dissociation, depression, confusion, hallucinations, paranoia, and psychosis. However, it is unclear if these adverse effects are due to the THC constituent of cannabis, other constituents, or a combination. For more information on cannabis-related adverse effects, see the Cannabis monograph.