A Natural, Inexpensive, Easily Accessible, Safer Treatment for Depression?St. John's Wort (SJW) has always been a safe and effective way to work with depression.
But if a group of pharmacists have their way, we may not have easy access anymore.
Pharmacists Planning Service (PPS), a “public health, consumer, and pharmacy education” nonprofit, is petitioning the FDA to change the designation of St. John’s Wort from “herbal dietary supplement status” to “behind pharmacy counter status” (BPCS)—a designation that requires pharmacist consultation—citing dangerous side effects and drug interactions.
Funny thing is, St. John's Wort is far safer than prescription depression medications. Unlike those medications, it has not been linked to addiction, suicide, or violent behavior. It also appears to be effective and has been used for many years in Germany and other countries to treat mild depression, especially in children and adolescents. A meta-analysis found that “the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly effective as standard antidepressants; c) and have fewer side effects than standard antidepressants.”
The “fewer side effects” issue is an important one. A 2000 study found that SJW “was superior to fluoxetine [Prozac] in overall incidence of side-effects, number of patients with side effects, and the type of side effect reported.” Similar studies found SJW superior to other SSRIs (selective serotonin reuptake inhibitors) as well. This actually understates the side effects risk issue for adolescents and young people. Black box warnings on SSRI’s warn of suicide risk for these groups; they should warn of violent behavior risk but do not. The FDA does not want to admit the evidence linking the drugs to violent behavior, including mass shootings.
Another, older class of antidepressants is TCAs (tricyclic antidepressants), which, according to a study from early 2011, are at least as effective against depression as SSRIs (this is faint praise, since SSRI’s have not been proven to be very effective). Although TCAs are slowly being replaced by SSRIs, they are still extremely popular: according to Pharmacy Times, in 2011 the most commonly prescribed drug in the US was a TCA called amitriptyline (sold under the trade names Tryptomer, Elavil, Tryptizol, Laroxyl, Saroten, Sarotex, Lentizol, and Endep).
Amitriptyline’s side effects range from anxiety, panic attacks, chest pain, sudden numbness to one side of the body, sudden severe headache, and problems with vision, speech, or balance, to suicidal ideation, hallucinations, seizures, and bleeding from the nose, mouth, vagina, or rectum.
Antidepressant drugs of all kinds are huge money-makers for drug companies: Antidepressants are used by 11% of Americans. Use has increased 400% over ten years. And, of those taking them, 60% report using for more than two years. Seven of the top eighteen prescribed drugs are antidepressants.
Because it is safe, effective, and relatively inexpensive, SJW poses serious competition to the US pharmaceutical industry. The thought of more and more people turning to an over-the-counter herb instead of relying on pharmaceutical drugs has pharmacists running scared.
If PPS is successful in its petition, St. John’s Wort will no longer be an easily accessible alternative to prescription drugs. PPS has a history of putting pharmacists between consumers and even over-the-counter products as much as possible—for example, the organization advocates mandatory pharmacist/consumer consultations and patient history checks.
There is no specific timeline for this petition: FDA has not yet responded to PPS’s petition, and it is still open for public comment. Action Alert! Please tell FDA that St. John’s Wort is a safe and time-tested remedy for mild depression, that the safeguards already built into the system with the warning on the label are completely adequate, and that druggists do not have the qualifications to play any such advisory role. No reclassification to “behind the counter status” is even remotely warranted. Please write to the FDA today!