PUBH 3131 Lecture Notes - Lecture 10: Medwatch, Sulfathiazole, Sulfanilamide
Epideiolog ad Dug Safet
Toda
The ipotae of dug safet eseah
The histo of the FDA appoal poess i ief
FDA appoal poess
Post-aketig safet issues
A e pai ediatio
A e ati-iflaato dug oes o the aket that suessfull teats hoi
pai due to athitis.
It is wildly successful and many patients find relief on this new
medication that did not previously.
But…
The dug ieases the isk of heat attak fo .% to.%.
You suffe fo hoi athitis pai ad iflaatio that has ot espoded ell
to othe theapies.
Do you take the new medication?
What if it increased risk from 5% to 10%?
Adese dug effets
A little histo o the FDA appoal poess
- The oigial Food ad Dug At is passed Cogess.
– Shele Aedet outlas fake edial lais.
– The Fedeal Food, Dug, ad Coseti At euies safet testig before
aketig folloig deaths of people fo elii sulfailaide i .
Moe histo o FDA appoal poess
– FDA hages aufatuig ad ualit otols afte deaths ad
ijuies fo sulfathiazole talets taited ith pheoaital.
– Thalidoide, a sleepig pill aketed to pegat oe, liked to
thousads of ith defets i Euope. FDA euies poof of effia efoe
aketig.
Moe eet
– FDA lauhes MedWath a sste that ollets epots fo health
pofessioals o dug poles.
– FDA lauhes Adese Eet Repotig Sste AERS to stoe ad stud
safet epots o aketed poduts.
FDA appoal poess
Radoized tials ae the gold stadad
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The adoized tials that ake up Phases - ae the gold stadad fo poidig
data o effia pio to dug appoal.
Randomization prevents investigators from assigning treatment
groups.
Randomization also leads to reasonable balance between groups on
both known and unknown factors.
But…
Poles ith adoized tials…
Shot duatio
Premarketing studies are often too short to identify events that occur
after chronic use or events with long latency.
Sall saple size
Even Phase 3 trials are usually limited to 1,000’s of patients, which
may not be enough to identify rare events.
Naol defied populatio
Premarketing trials do not usually include women of childbearing age,
children, elderly, those with many comorbidities.
Liited idiatios
Premarketing trials are focused on just one (or few) indications
Nao populatio
The alue of post-aketig studies
Post-aketig Phase IV studies poide useful data o:
Rare adverse events
Effectiveness versus efficacy
Efficacy is how well the medication works in the ideal setting of
clinical trials.
Effectiveness measures how well the drug works in the real-
world.
Safety and effectiveness in users with different characteristics:
Elderly
Multiple comorbidities and medications (drug interactions)
Females and children
Off-label uses
Less than perfect compliance
FDA MedWath
Phsiias ae epeted to epot a adese eets potetiall assoiated ith a
edial podut to the FDA usig the MedWath sste.
Repotig is oluta. Wh ight this e a pole?
find more resources at oneclass.com
find more resources at oneclass.com
Document Summary
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