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Herbal Products and Dietary SupplementsAmber Frick, PharmD

+Patient Case 1

One of your regular patients comes to pick up his Coumadin. In the checkout area, you see ginkgo supplements, green tea, and St. John’s Wort in his basket.

What general counseling point for herbal products is inappropriate?1. Just because this product is

considered natural, doesn’t mean it is safe.

2. There is not a lot of evidence on the effectiveness of herbal products.

3. You should avoid using herbal products, because there is not enough evidence for their use, and they can be dangerous.

4. Herbal products are not FDA-approved so caution should be taken when using these products.

+When should a patient not take herbal medications?

+Labels

DSHEA 1994: “This product is not intended to diagnose, cure, or prevent any disease.”

+Herbal Resources

Certifications United States Pharmacopeia (USP) http://www.usp.org/

National Sanitation Foundation (NSF) International http://www.nsf.org/ Consumer Lab https://www.consumerlab.com

Natural Medicines Comprehensive Database/Natural Standard

National Center for Complementary and Alternative Medicine http://nccam.nih.gov/

Which one of these herbal products are you most concerned will interact with his warfarin and will promptly caution him on?

1. Ginkgo supplements2. Green Tea3. St. John’s Wort4. All of the above

+Drug InteractionsThe G’s…

Herbal Documented Interactions Potential Interactions

Garlic• OCs: decreased effectiveness• Warfarin: increased INR• Saquinavir: 50% decrease in levels

• Induction of CYP3A4 and CYP2D6

Ginger • Antiplatelet drugs: additive effects at high dosages (> 4 g daily)

• Antihyperglycemic drugs: additive effects (avoid)

Gingko • Antiplatelet drugs: additive effect• Trazodone: case report of coma

• Seizure threshold lowering drugs: may precipitate seizures (avoid)• Antihypertensives: additive effects• Hydrochlorothiazide: case report of paradoxical hypertension

Ginseng• Antihyperglycemic drugs: lowered BG levels in type 2 DM (monitor)• Phenelzine: case report of headache, tremor, and mania

• Anticoagulant and antiplatelet drugs: unpredictable effect• Antipsychotics and immunosuppressants: interference• Inhibition of CYP2D6 (not clinically significant)

Green Tea•Decongestants: additive stimulant effect

• Sedatives: antagonism• Anticoagulants and antiplatelet drugs: additive effects at high dosages (> 4 g daily)• Warfarin: antagonism

+Drug Interactions… and St. John’s Wort

Herbal Documented Interactions Potential Interactions

St. John’s Wort

• CYP3A4 substrates: decreased drug levels and effects • OCs and hormone therapy: decreased activity • Antidepressants: increased risk of serotonin syndromes with nefazodone, sertraline, and paroxetine• Protease inhibitors and nonnucleoside reverse transcriptase inhibitors: decreased serum levels• Cyclosporine: decreased blood levels and case reports of transplant graft rejection

• Photosensitizing agents: contraindicated • 5-HT1 agonists, dextromethorphan, meperidine, pentazocine, and tramadol: increased risk of serotonin syndrome • Amiodarone: decreased levels and effect• Fexofenadine: toxicity (monitor)

+Patient Case 2

A patient asks for help in finding a natural product he heard about that might help with his muscle pain. He is taking Crestor 10 mg, lisinopril 20 mg, and aspirin 81 mg daily.

What is the remedy he is looking for, and how would he use it? What is one major counseling point?

Do you feel comfortable recommending it? If not, what additional information would you need from the patient?

What is your next course of action?

1. Treat the patient.2. Refer the patient.3. Request more information.

+CoQ10

Cardiovascular protectant and general antioxidant

Statin-associated effects

Dose Statin-associated effects: 100 mg daily for 30 days Other: 100 mg 1 to 3 times daily

Adverse Effects: GI distress Anorexia Headache Irritability Dizziness Procoagulant effects

+Patient Case 3

A patient has been told to start fish oil for his triglycerides. He has picked up three bottles and asks which one is best.

Which of the following fish oil products is best?

How much fish oil do you recommend? What is one major counseling point?

Which product do you recommend?

A

B

C

1. A2. B3. C

+Fish Oil

Triglyceride reduction agent, cardiovascular protectant, and anti-inflammatory

Dose Based on the amount of omega-3 (EPA and DHA) Cardiac protection: 1 g daily Triglyceride lowering: 3 to 5 g daily

Adverse effects Belching Fishy halitosis GI distress Bleeding

Increased risk: ≥ 4 g daily Concomitant anticoagulant: ≤ 3 g daily

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+Patient Case 4

A patient approaches you to ask about a natural product he heard he could try for “dribbling” when urinating. He is 59 years-old and wants to use something over-the-counter before going to see a physician.

What is the remedy he is looking for? When can he expect relief? What is one major counseling point?

Do you feel comfortable recommending it? If not, what additional information would you need from the patient?

What is your next course of action?

1. Treat the patient.2. Refer the patient.3. Request more information.

+Saw Palmetto

BPH treatment

5-alpha-reductase inhibitor

Adverse effects GI complaints Bleeding

Prostate cancer

+Patient Case 5

A patient, who looks fatigued, asks about using a natural product for recovering from traveling. She just returned from a international flight for a business trip and needs to return to her normal daytime work schedule.

What is the remedy she is looking for, and how would she use it? What is one major counseling point?

Do you feel comfortable recommending it? If not, what additional information would you need from the patient?

What is your next course of action?

1. Treat the patient.2. Refer the patient.3. Request more information.

+Melatonin

Insomnia treatment and “jet lag” prevention

Dose Synthesized melatonin Insomnia: 0.3 to 5 mg before

bedtime Jet lag: 2 to 5 mg in the evening

of the arrival day at destination and at bedtime for the following 2 to 5 days

Adverse effects N/V Headache Tachycardia Dysthmia and worsening of

depressive symptoms Morning “hangover” efffect

Drug interactions MAOIs Tricyclic antidepressants BZDPs Valproate Oral contraceptives Caffeine Verapamil Nifedipine Immunosuppressants Cancer chemotherapy

+Take Home Points

Increased herbal use

Evidence of safety and efficacy

Comparative effectiveness

“Natural” versus “safe”

USP standards

Health promotion and disease prevention

Clear communication

+What is your recommendation?

A patient comes to your pharmacy and is noticeably distressed. She went to the physician’s office one week ago, where she was diagnosed with diabetes. Rather than take medicine right away, she opted to attempt to make lifestyle modifications. Also, one of her friends told her about konjac glucomannan, but she would like your opinion before trying it.

What do you do next?

What is your advice regarding konjac glucomannan?