Safety and Efficacy of Weight Loss Supplements and Medication Used by

Adolescents'

M.S Phrm D Norah Al Johany

• Laxiatives (2nd Century)• Thyroid extract (Late 1800s)• DNP (1933 -1938)• AYDS (1940) Benzocaine• Tapeworm diet pills 1950’s• CNS Stimulant Amphetamines (1930s - 1950s ) Aminorex 1965 ,Phentermine 1959 ,Fenfluramine Sibutramine (1997-2010) Meridia

HISTORY Diet & Weight Loss Pills

• First significant guidelines since 1998!• American College of Cardiology / American

Heart Association • Very limited in pharmacotherapy• Stopped input in 2011, newer medications

approved in 2012• Diet / Exercise always cornerstone therapy

Recent Guidelines!!!

Medications Reserved For:Not achieving / sustaining weight reduction with

adequate lifestyle modifications and:

BMI 27+ kg/m2 with significant weight relatedcomorbidities (diabetes,hypertension)

ACC/AHA ObesityMedication Recommendations

Orlistat – Inhibits gastric and pancreaticlipases >> reduced fat absorption

Rx (Xenical): 120 mg three times daily (up to 1hour prior to meals)• LOTS GI ADRs: flatulence, oily stool, loose

stool• FDA 2012: Increased risk for kidney

stones/liver injury• KSA

FDA Approved Drugs /Obesity Therapy

Lorcaserin (approved 2012)• Selective serotonin 2C agonist• ADRs: HA, dizziness, nausea, dry mouth,• constipation, memory disturbances, hypoglycemia(in diabetes)• Efficacy: ~46% attain 5% wt loss, ~23% 10% loss• (good A1c reduction in patients with diabetes)• Avoid use if also taking serotonergic agents (e.g.• SSRIs)• Stop if < 5% weight loss after 12 weeks• (60)239$

Phentermine/extended-release topiramateShort term (approved 2012)ADRs: dry mouth, constipation,

insomnia, memory disturbances, increased heart rate Efficacy: 60+% attain 5% wt loss, 35-45% 10%

loss Women of childbearing age must have negative

pregnancy test before and monthly after startingStop if < 5% weight loss after 12 weeks of higher doses

FDA approves weight-management drug Contrave 2014Naltrexone is approved to treat alcohol and opioid dependence. Bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment.

Off-label Drugs /Obesity Therapy

• Zonisamide• Metformin• Pramlintide

• How long to treat for???• No head to head comparative studies• Long-term safety

Obesity Therapy Issues

Supplements

• weight-loss supplements differ from over-the-counter or prescription medications

• FDA does not classify them as drugs.• Unlike drugs, dietary supplements do not

require premarket review or approval by the FDA. Supplement manufacturers are responsible for determining that their products are safe and their label claims are truthful and not misleading

Supplements

FDA has issued over 30 public notifications and recalled 7 tainted weight loss products in 2014 .

1. Garinia cambogia exract2. CLA3. Raspberry Ketones 4. Apple Cider Vinegar 5. Green Coffee Bean 6. Fiber 7. Colon Cleanse

Amazon Best Sellers Weight Loss Supplements

Raspberry Ketones

CLA

Green Coffee Bean

Garinia cambogia exract

Fiber

Colon Cleanse

Patient CaseA patient is taking the maximum dose ofphentermine/topiramate for obesity.Baseline BMI is 36 kg/m2 and weight 255 lb.

What is minimal weight loss expected toconsider continuation of therapy after 12

weeks?a. 7 lbsb. 13 lbsc. 17 lbsd. 26 lbs1-

“We’re raising our children the way we raise calves for veal - keep them in

boxes, feed them too much, and allow them no exercise”.

Rich KillingsworthCenter for Disease Control and Prevention

Outline Summary