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cannabidiol

While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.

As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.

1. What are cannabis and marijuana?

Children and Pregnant/Lactating Women

The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.

26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?

21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?

A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.

Parkinson disease: Some early research suggests that taking high doses of cannabidiol might make muscle movement and tremors worse in some people with Parkinson disease.

Some medications changed by the liver include testosterone, progesterone (Endometrin, Prometrium), nifedipine (Adalat CC, Procardia XL), cyclosporine (Sandimmune), and others. Medications changed by the liver (Glucuronidated drugs) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. Taking cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of these medications.
Some of these medications changed by the liver include acetaminophen (Tylenol, others) and oxazepam (Serax), haloperidol (Haldol), lamotrigine (Lamictal), morphine (MS Contin, Roxanol), zidovudine (AZT, Retrovir), and others. Medications that decrease the breakdown of other medications by the liver (Cytochrome P450 2C19 (CYP2C19) inhibitors) Cannabidiol is broken down by the liver. Some medications might decrease how quickly the liver breaks down cannabidiol. Taking cannabidiol along with these medications might increase the effects and side effects of cannabidiol.
Some medications that might decrease the breakdown cannabidiol in the liver include cimetidine (Tagamet), fluvoxamine (Luvox), omeprazole (Prilosec); ticlopidine (Ticlid), topiramate (Topamax), and others. Medications that decrease the breakdown of other medications in the liver (Cytochrome P450 3A4 (CYP3A4) inhibitors) Cannabidiol is broken down by the liver. Some medications might decrease how quickly the liver breaks down cannabidiol. Taking cannabidiol along with these medications might increase the effects and side effects of cannabidiol.
Some medications that might decrease how quickly the liver breaks down cannabidiol include amiodarone (Cordarone), clarithromycin (Biaxin), diltiazem (Cardizem), erythromycin (E-mycin, Erythrocin), indinavir (Crixivan), ritonavir (Norvir), saquinavir (Fortovase, Invirase), and many others. Medications that increase breakdown of other medications by the liver (Cytochrome P450 3A4 (CYP3A4) inducers) Cannabidiol is broken down by the liver. Some medications might increase how quickly the liver breaks down cannabidiol. Taking cannabidiol along with these medications might decrease the effects of cannabidiol.
Some of these medicines include carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), rifampin, rifabutin (Mycobutin), and others. Medications that increase the breakdown of other medications by the liver (Cytochrome P450 2C19 (CYP2C19) inducers) Cannabidiol is broken down by the liver. Some medications might increase how quickly the liver breaks down cannabidiol. Taking cannabidiol along with these medications might decrease the effects of cannabidiol.
Some medications that might increase the breakdown of cannabidiol in the liver include carbamazepine (Tegretol), prednisone (Deltasone), and rifampin (Rifadin, Rimactane). Methadone (Dolophine) Methadone is broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down methadone. Taking cannabidiol along with methadone might increase the effects and side effects of methadone. Rufinamide (Banzel) Rufinamide is changed and broken down by the body. Cannabidiol might decrease how quickly the body breaks down rufinamide. This might increase levels of rufinamide in the body by a small amount. Sedative medications (CNS depressants) Cannabidiol might cause sleepiness and drowsiness. Medications that cause sleepiness are called sedatives. Taking cannabidiol along with sedative medications might cause too much sleepiness.

Some medications changed by the liver include proton pump inhibitors including omeprazole (Prilosec), lansoprazole (Prevacid), and pantoprazole (Protonix); diazepam (Valium); carisoprodol (Soma); nelfinavir (Viracept); and others. Medications changed by the liver (Cytochrome P450 2C8 (CYP2C8) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.
Some medications changed by the liver include amiodarone (Cordarone), carbamazepine (Tegretol), chloroquine (Aralen), diclofenac (Voltaren), paclitaxel (Taxol), repaglinide (Prandin) and others. Medications changed by the liver (Cytochrome P450 2C9 (CYP2C9) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.

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Some medications changed by the liver include nicotine, chlormethiazole (Heminevrin), coumarin, methoxyflurane (Penthrox), halothane (Fluothane), valproic acid (Depacon), disulfiram (Antabuse), and others. Medications changed by the liver (Cytochrome P450 2B6 (CYP2B6) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.

Some medications changed by the liver include chlorzoxazone (Lorzone) and theophylline (Theo-Dur, others). Medications changed by the liver (Cytochrome P450 1A2 (CYP1A2) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.

Some medications changed by the liver include ketamine (Ketalar), phenobarbital, orphenadrine (Norflex), secobarbital (Seconal), and dexamethasone (Decadron). Medications changed by the liver (Cytochrome P450 2C19 (CYP2C19) substrates) Some medications are changed and broken down by the liver. Cannabidiol might decrease how quickly the liver breaks down some medications. In theory, using cannabidiol along with some medications that are broken down by the liver might increase the effects and side effects of some medications. Before using cannabidiol, talk to your healthcare provider if you take any medications that are changed by the liver.

Children: A prescription cannabidiol product (Epidiolex) is POSSIBLY SAFE when taken by mouth in doses up to 25 mg/kg daily. This product is approved for use in certain children 1 year of age and older.

A recent chart review of 72 psychiatric patients treated with CBD found that anxiety improved, but not sleep. “Over all, we did not find that it panned out as a useful treatment for sleep,” said Dr. Scott Shannon, assistant clinical professor of psychiatry at the University of Colorado, Denver and the lead author of the review in The Permanente Journal.

Many soldiers return home haunted by war and PTSD and often avoid certain activities, places or people associated with their traumatic events. The Department of Veterans Affairs is funding its first study on CBD, pairing it with psychotherapy.

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“Our top therapies attempt to break the association between reminders of the trauma and the fear response,” said Mallory Loflin, an assistant adjunct professor at the University of California, San Diego and the study’s principal investigator. “We think that CBD, at least in animal models, can help that process happen a lot faster.” While large clinical trials are underway, psychologists say there isn’t compelling evidence yet as to whether this is a viable treatment.

Earlier research found fewer than a third of 84 products studied contained the amount of CBD on their labels. Some users of CBD have also failed drug tests when the product contained more THC than indicated.

Sleep can be disrupted for many reasons, including depression. Rodents seemed to adapt better to stressful conditions and exhibited less depressive-like behavior after taking CBD, according to a review in Journal of Chemical Neuroanatomy. “Surprisingly, CBD seems to act faster than conventional antidepressants,” wrote one of the authors of a new review, Sâmia Joca, a fellow at the Aarhus Institute of Advanced Studies in Denmark and an associate professor at the University of São Paulo in Brazil, in an email interview. Of course, it’s difficult to detect depression in animals, but the studies that Ms. Joca and her colleagues reviewed suggested that in models of chronic stress exposure, the mice and rats treated with CBD were more resilient.

Dr. Smita Das, chair of the American Psychiatric Association’s Council on Addiction Psychiatry’s cannabis work group, does not recommend CBD for anxiety, PTSD, sleep or depression. With patients turning to these to unproven products, she is worried that they may delay seeking appropriate mental health care: “I’m dually concerned with how exposure to CBD products can lead somebody into continuing to cannabis products.”