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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 related
comorbidities (diabetes,hypertension)
ACC/AHA Obesity
Medication Recommendations
Orlistat – Inhibits gastric and pancreatic
lipases >> reduced fat absorption
Rx (Xenical): 120 mg three times daily (up to 1
hour 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 topiramate
Short 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 starting
Stop if < 5% weight loss after 12 weeks of higher doses
FDA approves weight-management drug
Contrave 2014
Naltrexone 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 exract
2. CLA
3. 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 Case
A patient is taking the maximum dose of
phentermine/topiramate for obesity.
Baseline BMI is 36 kg/m2 and weight 255 lb.
What is minimal weight loss expected to
consider continuation of therapy after 12
weeks?
a. 7 lbs
b. 13 lbs
c. 17 lbs
d. 26 lbs
1-
“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 Killingsworth
Center for Disease Control and Prevention
Outline Summary

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Noura wl

  • 1. Safety and Efficacy of Weight Loss Supplements and Medication Used by Adolescents' M.S Phrm D Norah Al Johany
  • 2.
  • 3.
  • 4. • 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
  • 5. • 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!!!
  • 6. Medications Reserved For: Not achieving / sustaining weight reduction with adequate lifestyle modifications and: BMI 27+ kg/m2 with significant weight related comorbidities (diabetes,hypertension) ACC/AHA Obesity Medication Recommendations
  • 7. Orlistat – Inhibits gastric and pancreatic lipases >> reduced fat absorption Rx (Xenical): 120 mg three times daily (up to 1 hour 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
  • 8. 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$
  • 9. Phentermine/extended-release topiramate Short 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 starting Stop if < 5% weight loss after 12 weeks of higher doses
  • 10. FDA approves weight-management drug Contrave 2014 Naltrexone 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.
  • 11.
  • 12. Off-label Drugs /Obesity Therapy • Zonisamide • Metformin • Pramlintide
  • 13. • How long to treat for??? • No head to head comparative studies • Long-term safety Obesity Therapy Issues
  • 15.
  • 16. • 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
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23. FDA has issued over 30 public notifications and recalled 7 tainted weight loss products in 2014.
  • 24.
  • 25.
  • 26. 1. Garinia cambogia exract 2. CLA 3. Raspberry Ketones 4. Apple Cider Vinegar 5. Green Coffee Bean 6. Fiber 7. Colon Cleanse Amazon Best Sellers Weight Loss Supplements
  • 28. CLA
  • 31. Fiber
  • 33. Patient Case A patient is taking the maximum dose of phentermine/topiramate for obesity. Baseline BMI is 36 kg/m2 and weight 255 lb. What is minimal weight loss expected to consider continuation of therapy after 12 weeks? a. 7 lbs b. 13 lbs c. 17 lbs d. 26 lbs 1-
  • 34. “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 Killingsworth Center for Disease Control and Prevention

Editor's Notes

  1. McGraw Hill - www.mhhe.com