Geffrey AL, et al. Up to 10 msg/mo. The agency is responsible for overseeing the cultivation of cannabis for medical research and has contracted with the University of Mississippi to grow cannabis for research at a secure facility. [4] Silva, et al. US-EPX-2200685 Some states have legalized CBD, so be sure to check state laws, especially when traveling. What is FDAs reaction to states that are allowing cannabis to be sold for medical uses without the FDAs approval? With respect to products labeled to contain "hemp" that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added. Is EPIDIOLEX compatible with the ketogenic diet? Use this worksheet to keep track as you start EPIDIOLEX and work toward the dose thats right for you. Are they safe? It has low affinity for cannabinoid type 1 and cannabinoid type 2 receptors and is thought to exert its effects via other mechanisms. Setting up and preparing to administer EPIDIOLEX. Once your insurance coverage is confirmed, the prescription will be filled and the medicine will be shipped directly to your home. App Store is a service mark of Apple Inc. Google Play and the Google Play logo are trademarks of Google LLC. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX: EPIDIOLEX may cause you to feel sleepy, which may get better over time. Hemp seeds are the seeds of the Cannabis sativa plant. DOI: Grapefruit juice and some drugs dont mix: Grapefruit juice can affect how well some medicines work, and it may cause dangerous side effects. Disponible en Espaol, Administering EPIDIOLEX trouble breathing. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. 449 b. Ive seen cannabis products being marketed for pets. 2. References: 1. FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application (IND) that has gone into effect. However, CBD products containing more than 0.3% THC still fall under the legal definition of marijuana, making them illegal at the federal level. 0 B. Over 80 chemicals . Addict Biol 2007; 12(3-4): 485495. What is FDAs role when it comes to the investigation of cannabis and cannabis-derived products for medical use? A. What is FDAs reaction to states that are allowing cannabis to be sold for medical uses without the FDAs approval? Reference: 1. The Governor, Legislature, Attorney General, and the public all have a role to play when Boards adopt rules -- there are many checks and balances. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding. All rights reserved. Cannabis of varying potencies and compositions is available. Please certify that you are a healthcare professional by clicking the appropriate link below. Neuropsychiatr Dis Treat. What the Research Says, The Entourage Effect: How CBD and THC Work Together, CBD Doesnt Mitigate Negative Effects of THC in Cannabis, Study Finds, 6 CBD Skin Care Brands That Actually Live Up to the Hype, The 9 Best CBD Pills and Capsules of 2023, GI medications, such as to treat GERD or nausea, mood medications, such as to treat anxiety, depression, or mood disorders. nausea. For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. Why hasnt FDA approved more products containing cannabis or cannabis-derived compounds for medical uses? Ive seen cannabis products being marketed for pets. 3. Researchers found elevated levels of the clobazam in these children. Patients Qualified Patients (Active ID Card): 794,779 . Sicherer SH, Munoz-Furlong A, Godbold JH, Sampson HA. It is a component of some dietary supplements and cosmetics. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Cannabidiol (CBD) is one of these cannabinoids. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Now that youve been prescribed EPIDIOLEX, youre probably eager to get started. 2017;13:1131-1140. A. 2020;77(5):613-621. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill. How does the 2018 Farm Bill define hemp? 4. 361(a)]). TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. Pharmacists are challenged to practice in a time of rapidly changing state and local laws surrounding cannabinoids, which in many cases differ from federal law. Can EPIDIOLEX be administered through a feeding tube? EPIDIOLEX may cause liver problems. You may also contact Jazz Pharmaceuticals at 1-833-424-6724. Psychopharmacology (Berl) 2008; 198(4): 529-537. Some substances also speed up the work of the CYP450 enzyme family. Medical marijuana is a term for derivatives of the Cannabis sativa plant that are used to ease symptoms caused by certain medical conditions. The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. 802(16)]. Does the FDA have concerns about administering a cannabis product to children? shadwell, london crime; lord capulet character traits; Early studies looking at CBD as a possible diabetes treatment have shown encouraging results, particularly in the areas of prevention, inflammation, CBD comes from the hemp plant, does not contain THC, and has been used by some parents to treat seizures in children. Step-by-step instructions for taking EPIDIOLEX or giving it to a loved one. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age. FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. The CBD doses were increased every 2 weeks. NIDA provides research-grade cannabis for scientific study. Under the OMMCP, qualified patients can purchase medical marijuana as tinctures, cannabis oils, plant materials, edibles, lotions, patches, and creams. Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one . The CYP450 family of enzymes is responsible for metabolizing several cannabinoids, including CBD, research shows. 2. Poster presented at: American Epilepsy Society Annual Meeting; December 6-10, 2019; Baltimore, MD. Research on CBD oil for migraine is limited, but some evidence suggests that it may help relieve chronic or acute pain. Patients should contact the American consulate in their destination country and research the country's cannabis/marijuana laws prior to travel. EPIDIOLEX may cause liver problems. Multiple possible pharmacological targets exist for CBD, but few have been verified. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? The following information is designed and organized to help certified patients and caregivers understand Iowa's Medical Cannabidiol Program. The bottom line is to always consult your doctor first if youd like to try CBD, especially if you have a health condition and are taking medications. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Dont stop taking your prescription medications to try CBD, unless you have the go-ahead from your doctor. To date, no such regulation has been issued for any substance. See our updated Prescribing Info, featuring TSC information, here. Unlike oils, edibles, and vaping solutions, topicals dont typically enter the bloodstream as long as theyre not a transdermal solution intended to do so. how many kids does james brown have; broad college of business acceptance rate +91 99252 51980. edgewood ky soccer league. Product requirements. Put one or more drops of CBD oil under the tongue and wait 30-60 seconds before swallowing. A. Medical researchers have confirmed what some desperate parents have been claiming for yearsthat a nonpsychoactive component of marijuana known as cannabidiol (CBD . What should I do if my child eats something containing cannabis? Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Researchs. Reply STOP to 95752 to cancel, HELP for help. to focus on the health and safety of Florida's families and is dedicated to ensuring patients have safe access to low-THC cannabis and medical marijuana. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women? FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products meaning theyre subject to the same authorities and requirements as FDA-regulated products containing any other substance. The European Commission considers that CBD qualifies as a novel food provided it meets the . The site is secure. BMJ Open. Controlled substances include poisons, compositions containing poisons . EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product. Scheffer IE, Halford J, Nabbout R, et al. Chemist Warehouse, Australia's largest pharmacy chain, will be able to supply low-dose cannabidiol (CBD) products to the masses thanks to an exclusive supply deal with . You and your healthcare provider will have to decide if you should take EPIDIOLEX while you are pregnant. Poster presented at: American Epilepsy Society Annual Meeting; December 6-10, 2019; Baltimore, MD. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Medications that come with a grapefruit warning are likely to interact with CBD. Check your medications insert information or ask your doctor. The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. One specific form of CBD is approved as a drug in the U.S. for seizures. FDAs December 2016 Guidance for Industry: Botanical Drug Developmentprovides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. 23. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries and regions. She earned her Master of Science in journalism from Northwesterns Medill. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. At the federal level, the Agriculture Improvement Act of 2018, Pub. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors FDA is not involved in these decisions. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added? FDA relies on applicants and scientific investigators to conduct research. Can I import or export cannabis-containing or cannabis-derived products? Research to date shows that CBD is generally safe and has few, if any, minor side effects. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries and regions. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available. California. Pay particular attention to Lousiana which has a 3% excise tax on cannabidiol. If you are interested in RTT, you should discuss this pathway with your licensed physician. CBD is often treated like a wonder ingredient. In some cases, EPIDIOLEX treatment may need to be stopped. The best known are delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Does the FDA have concerns about administering a cannabis product to children? Your doctor or pharmacist may also be able to recommend a quality CBD product that fits your needs. We need more research but CBD may prove to be a helpful, relatively non-toxic option for managing anxiety, insomnia, and chronic pain. Download the EPIDIOLEX Dosing Calculator for Android or iOS. The number of states which have NOT approved any type or form of marijuana for medical use is: A. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDAs MedWatch reporting system, either online or by phone at 1-800-FDA-1088. But does it actually help your skin, or is it all hype? Patel AD, Chin RF, Mitchell W, et al. What does the FDA think about making CBD available to children with epilepsy? Can approved human drugs containing CBD or synthetic THC be used extralabel in animals? Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food? Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drugs uses and risks. Whether you want a product for pain or all-purpose use, here are 8 great recommendations. JAMA Neurol. Over 80 chemicals, known as . Morphine alone produced antinociceptive effects in all three models of acute nociception, whereas CBD . Cannabis sativa contains many active compounds. Even if a CBD product meets the definition of "hemp" under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. Get tips on dosage here. In general, these tests are not specific or selective for tetrahydrocannabinol (THC) and therefore, may detect other cannabinoids, including cannabidiol, In order to determine specific exposure and concentrations of cannabinoids, a specific blood test is required, Patients/caregivers should inform the person giving the drug test that the patient is taking EPIDIOLEX, an FDA-approved medicine prescribed by their physician, In controlled and uncontrolled trials, an expanded access program, and other compassionate use programs, 1183 patients with LGS, Dravet syndrome, and TSC have been treated with EPIDIOLEX, 683 patients treated for more than 1 year, 155 patients treated for more than 2 years, EPIDIOLEX was also studied in open-label extension trials up to 3 years in LGS and Dravet syndrome, and 48 weeks in patients with TSC. What does the FDA think about making CBD available to children with epilepsy? Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food? Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Call your doctor right away if. Providing information on the process needed to conduct clinical research using cannabis. 350b(d)]). Ostendorf AP, Ng YT. Epidyolex (cannabidiol) and Sativex (nabiximols) are the only cannabis medicines currently registered in Australia on the Australian Register of Therapeutic Goods (ARTG). In some cases, EPIDIOLEX treatment may need to be stopped. Medicinal cannabis products are classified as either Schedule 3, Schedule 4 or Schedule 8 . Hematologic abnormalities were also observed. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. (2015). Researchers monitored the serum levels of the AEDs in subjects over time. A. EPIDIOLEX is an oral solution that is taken twice daily. In another study, 39 adults and 42 children taking AEDs were also given CBD in the form of Epidiolex. Cannabidiol (CBD) is a chemical in the Cannabis sativa plant, also known as cannabis or hemp. For MMTC contact information and dispensing location addresses . It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. Always consult a doctor before. Thiele EA, Marsh ED, French JA, et al. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drugs uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. cannabidiol has to be dispensed with | July 01 / 2022 | summer bartholomew picturessummer bartholomew pictures A pharmaceutical processor or cannabis dispensing facility shall dispense or deliver cannabis products only in person to (i) a patient who is a Virginia resident or temporarily resides in Virginia and has been issued a valid written certification; (ii) such patient's registered agent; or (iii) if such patient is a minor or a vulnerable adult as . sedation. Cells were dispensed into 96-well plates (10000 cells per well) and treated as indicated The bill requires the Board to promulgate regulations establishing dosage limitations, which . Medicinal cannabis potential drug interactions. To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. 21. The question of the legality of CBD is a big one that can become quite confusing depending on who you ask.. We're going to do our best to clear up any confusion you might have about state-specific CBD laws. in patients 1 year of age and older. As of January 2016, eight dispensaries (not pharmacies . 10 drops 2.5mg = 0.5mL. Disponible en Espaol, What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)? FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. Do not start or stop other medicines without talking to your healthcare provider. With this CBD oil dosage calculator as your guide, you would find that you needed to consume 10 drops, or 0.5 milliliters, to reach 25 . The following states have legalized medical and recreational marijuana: Alaska. Disponible en Espaol, Cleaning up Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act? The major pharmacy chain Walgreens has informed Iowa Attorney General Brenna Bird that the company will not dispense a drug commonly used for medication abortions and miscarriage care in the state. (2017). EN 1. Google Play and the Google Play logo are trademarks of Google LLC. As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. CONTRAINDICATION: HYPERSENSITIVITY EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product. 801 and the implementing regulations in 21 CFR 1300. Specialty pharmacies have expertise in preparing and filling medicines like EPIDIOLEX. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. Let's start with the 2018 Farm Bill and how it affected CBD laws across the United States.. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. (2017). CBD can change the way your body processes certain medications, fda.gov/consumers/consumer-updates/grapefruit-juice-and-some-drugs-dont-mix, ncbi.nlm.nih.gov/pmc/articles/PMC4093435/, 8 Best CBD Lotions, Creams, Salves, and More, Dominique Fontaine, BSN, RN, HNB-BC, HWNC-BC, Can CBD Oil Be Used to Treat or Prevent Diabetes? You must have JavaScript enabled to use this form. For example, in one study of 25 children with hard-to-treat epilepsy, 13 kids were given both clobazam and CBD. The entourage effect theorizes that THC and CBD work better when taken together than alone. But during this process, CBD also interferes with CYP3A4. [7] ACOG Committee Opinion: Marijuana Use During Pregnancy and Lactation, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Accelerating Access to Critical Therapies for ALS Act ACT for ALS, Infant Formula Information and Ongoing FDA Efforts to Increase Supply, Informacin sobre la frmula infantil y los esfuerzos continuos de la FDA para aumentar su suministro, FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD), FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward, FDA Issues Response to Three Citizen Petitions related to CBD and Dietary Supplements, FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD, FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals, FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products, FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief, FDA Warns Companies Illegally Selling CBD Products, FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease, FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction, FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity, FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns, FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinsons and Alzheimers disease, FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer's disease, opioid withdrawal, pain and pet anxiety, FDA is Committed to Sound, Science-based Policy on CBD, Statement on new steps to advance agencys continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, Statement on signing of the Agriculture Improvement Act and the agencys regulation of products containing cannabis and cannabis-derived compounds, Statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components, FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy, FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer, What the FDA is Doing to Protect Consumers from Cannabidiol (CBD) in Foods, FDA Warns Consumers About the Accidental Ingestion by Children of Food Products Containing THC, 5 Things to Know about Delta-8 Tetrahydrocannabinol -- Delta-8 THC, What You Need to Know (And What Were Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD, What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding, Remarks at the Council forFederal Cannabis Regulation Webinar: Understanding FDAs Approach to Cannabis Science, Policy, and Regulation, Remarks at the Council for Responsible Nutrition Conference, Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit, Congressional Testimony: Hemp Production and the 2018 Farm Bill, Congressional Testimony: Cannabis Policies for the New Decade, Remarks at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Science Board to the FDA 2022: Challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, Safety of CBD in Humans A Literature Review, Public Hearing, May 2019: Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Reopening of the Comment Period (uncertainties and data gaps), Information on CBD Data Collection and Submission, Scientific Conference on November 19, 2020: CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses, Warning Letters for Cannabidiol-Related Products, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry, FDA and Cannabis: Research and Drug Approval Process, FDA Regulation of Dietary Supplement & Conventional Food Products Containing Cannabis and Cannabis-Derived Compounds. Is CBD legal? EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. N Engl J Med. EN EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards. What about the products Ive seen in stores or online? (2013). Once that dose is reached, your doctor will evaluate your response. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access? The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Can this product be used in patients with moderate or severe hepatic impairment? Inform patients, caregivers, and families of the risk and advise to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. It has also been approved by FDA for various orphan diseases for exploratory trials. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added? Additionally: 17. Jazz Pharmaceuticals is not responsible for content on external, third-party websites. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development. Cannabidiol may have therapeutic potential in the treatment of alcoholic liver diseases associated with inflammation, oxidative stress and steatosis, which deserves exploration in human trials. What additional monitoring for liver transaminase and bilirubin levels is recommended? 10. Cannabidiol, or CBD, is one of over 60 active compounds in the cannabis plant. Your doctor may also request blood work to evaluate liver function before you start and during treatment.