Adverse Drug Reactions
When coincidence becomes incidence
Adverse Drug Reactions
 Putting ADRs Occurence in Context

  •    Adverse drug reactions are believed to cause over 100,000 deaths per year in the U.S.
  •    Serious adverse events are among the top 5 causes of death
  •    ADRs caused over 2 million hospitalizations in 1994 alone   
  •    Drug-related mortality/morbidity estimated to cost U.S. health care system > $150 billion yearly  
  •    In 2000 ADRs represents > 5-10% of total U.S. health care spending
  •    19 drugs have been withdrawn from the market since 1998
  •    26% of drugs introduced 1980-2006 have black box warnings  
  •    Genetic risk factors for SAEs (Serious Adverse Effects) remain largely unknown
FDA/CDER/PhRMA/AASLD Meeting “Detecting and Investigating Drug Induced Adverse Events …
the International Serious Adverse Event Consortium’s Experience to Date” March 27, 2008
Arthur Holden, Chairman, SAEC Ltd.


 Stevens Johnson Syndrome/Toxic Epidermal Necrolysis

TOXIC epidermal necrolysis and Stevens–Johnson syndrome are acute life-threatening conditions.
Epidermal necrosis causes erosions of the mucous membranes, extensive detachment of the epidermis,
and severe constitutional symptoms.

When there is very extensive skin detachment and a poor prognosis (death rates of 30 to 40 percent), the condition is
usually called toxic epidermal necrolysis. Milder forms are known as Stevens–Johnson syndrome or overlapping
Stevens–Johnson syndrome and toxic epidermal necrolysis. Toxic epidermal necrolysis is usually drug-related.

Drugs are an important cause of Stevens–Johnson syndrome... In case reports and studies, more than 100 drugs
have been implicated as causes of Stevens–Johnson syndrome or toxic epidermal necrolysis. A limited number of
drugs, including sulfonamides, anticonvulsant agents, and allopurinol, are the most consistently associated with the
conditions; whether nonsteroidal antiinflammatory drugs (NSAIDs), analgesic agents, and nonsulfonamide antibiotics
are associated with them is controversial.

The relative risk associated with the use of specific drugs has never been quantified.
 THE NEW ENGLAND JOURNAL OF MEDICINE Dec. 14, 1995
 
MEDICATION USE AND THE RISK OF STEVENS–JOHNSON SYNDROME OR TOXIC EPIDERMAL NECROLYSIS
These pages are a work in progress.
All feedback, personal histories, etc. are
welcome as are inquiries regarding using
this material on other websites.
Please write auntie@aardvarksfly.com.
A special thanks to Dr. Brian L. Strom, MD., MPH,
for use of his PowerPoint,
Improving Drug Safety,
the single ray of light found in FDA's morass.
Steven Johnson Syndrome Foundation