After shedding its unsavory image as a dangerous narcotic, “medical marijuana” and “marijuana drugs” are at the forefront of medical research. While such medications appear to be effective for their intended purposes, known side effects could limit their future widespread use and also expose both manufacturers and physicians to allegations of manufacturing and prescribing a dangerous or defective drug.
In today’s post the dangerous drug lawyer at The Doan Law Firm takes a look at the first FDA-approved drugs in this class and then reviews that legal issues that could arise as these new medications become more widely accepted by the medical community.
What is a “cannabis-derived drug?”
We define a “cannabis-derived drug” to be a drug containing any substances that are isolated or synthesized from plants of the cannabis family. The substances most frequently isolated from cannabis are THC, which is responsible for the “high” associated with cannabis use and CBD, which is reported to have several beneficial effects but does not produce mood changes in users. Drugs in this category are prescribed for severe nausea and vomiting, increasing appetite, and control of nervous system disorders such as epilepsy.
Prescription-only CBD medications
Currently, the only FDA-approved medication that contains CBD is Epidiolex®, which is used to treat rare seizure disorders (epilepsy) affecting infants and children ( Lennox-Gastaut syndrome and Dravet syndrome) and seizures associated with the poorly-understood tuberous sclerosis complex. However, after noting that the changes in brain tissue seen in conditions such as Parkinson’s Disease (PD) and Multiple Sclerosis (MS) were similar to those seen in children with seizure disorders, doctors began prescribing Epidiolex® “off-label” to adults to treat symptoms of those conditions. “Off-label” prescribing means using a drug to treat any medical condition other than one “approved of” by the FDA. “Off-labeling” is common in clinical medicine and current research has shown that many PD and MS patients have reported symptomatic improvement with Epidiolex®.
Side effects reported by users of Epidiolex® include:
In rare cases, allergic reaction to Epidiolex® has been reported and its safety in pregnancy has not been established.
Prescription-only THC medications
Marinol® is based on a synthetic (man-made) portion of the THC molecule known as dronabinol and is FDA-approved for the treatment of the severe nausea and vomiting that frequently occur during cancer chemotherapy and to combat the severe weight loss and muscle wasting that can occur in HIV/AIDS. Dronabinol has also been shown to significantly improve sleep apnea scores and is said to have analgesic (pain relief) effects as well. Syndros® is another drug based on dronabinol and has the same clinical profile as Marinol®.
Known side effects reported with Marinol®/Syndros® use are usually mild to moderate in severity and include:
dizziness, especially upon standing
In addition to the possibility of developing physical dependence on THC/dronabinol, Cannabinoid Hyperemesis Syndrome (CHS) has been increasingly diagnosed in patients reporting heavy recreational or medical marijuana use.
In CHS, as the patient’s daily intake of marijuana products increases they find themselves suffering from abdominal pain and repeated episodes of vomiting that are only made better after ingesting more marijuana or marijuana-based medication. If misdiagnosed as some other gastrointestinal condition, CHS could progress to the point where the body could suffer internal trauma from repeated, violent vomiting or could enter into a state of electrolyte imbalance that could affect the normal function of organs such as the heart and kidneys.
Sativex® is based on a combination of THC and CBD and is available outside the United States (e.g. in Mexico and Canada) for the treatment of the severe muscle spasms often seen in PD and, less-occasionally, in MS. Since FDA approval of Sativex® is not expected for several years, many in the U.S. have turned to “legal” CBD preparations purchased from online sources or from local retailers or, in “medical marijuana” states, to dispensaries where they purchase cannabis strains with known THC/CBD ratios to “self-medicate” their PD/MS symptoms. Some patients have even been known to engage in “medical tourism,” traveling to a country where Sativex® is available where they obtain a six-month to one-year supply of the drug from a legitimate medical practitioner and then return to the United States.
The reported side-effects of Sativex® are generally milder than those associated with THC/dronabinol and include:
Although the side effects of Sativex® are milder than those encountered with other medications, the drug is not without risk. Since most reported side effects of Sativex® seem to relate to mental alertness, activities requiring alertness (driving, operating machinery or household appliances) could be expected to suffer if the patient is under the influence of Sativex®.
Risks associated with cannabis drugs
There are always risks associated with any type of drug therapy. Risks associated with cannabis drugs include:
Interactions with other medications
The active compounds of cannabis are known to interfere with an enzyme that breaks down a certain class of antibiotics. This could lead to a potentially toxic accumulation of antibiotics in patients taking those medications.
Safety in pregnancy
According to the FDA Marinol® “… may cause fetal harm.” The same agency states that prescribers should “Avoid use of Syndros® in pregnant women.” The maker of Sativex® states that it is “… contraindicated in pregnant women” and “… should not be used in women who intend to start a family.” There is insufficient data available for Epidiolex®.
Driving or operating machinery
Since all cannabis-derived medications have been reported to cause drowsiness or a decrease in hand-eye coordination, patients using these prescription drugs should be cautioned against driving or operating machinery until they grow accustomed to the drugs’ side effects.
In this post we have seen that cannabis-derived drugs may offer significant relief of symptoms in several difficult to treat disease conditions. However, as is the case with any medication, cannabis-derived drugs are not without known side effects.
If you believe that you have suffered an injury that is directly related to a cannabis-derived drug, we invite you to contact the dangerous drug lawyer at The Doan Law Firm to arrange a free review of the facts in your case and a discussion of the legal options that may be available to you.
When you contact our firm, your case review and first consultation with our dangerous drug lawyer are always free and do not obligate you hiring us as your legal counsel. Should you decide that a lawsuit is in order, and that you would like to have our firm represent you in court, we are willing to assume full responsibility for all aspects of preparing your case for trial in exchange for an agreed-upon percentage of the final settlement that we are prepared to win for you.