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Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

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Medical Prouct Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.  The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.  More information


Stevens-Johnson syndrome treatments and Related Information
Celebrex Related Information


Children's  Motrin / Advil Related Information
  • Parents of stricken girl sue makers of Children's Motrin

       Mercury News
    The parents of a 9-year-old Saratoga girl have sued the makers of Children's Motrin,
    claiming the flu and pain medication caused the extreme allergic reaction that left their daughter, Kaitlyn Langstaff, unable to see, speak or eat.
    The lawsuit filed in U.S. District Court in San Jose also alleges that the manufacturer of the drug failed to adequately test it for Dilantin Cerebellar Atrophy Risks use with children and failed to warn the public of potentially fatal reactions to Children's Motrin.

  • Children's Motrin (Ibuprofen) Oral Suspension, Junior Strength Motrin Chewable Tablet, Junior Strength Motrin Tablets & Drops, Company: McNeil Consumer Products Company
    Application No.: 20-516/S4, 20-601/S2, 20-602/S3 & 20-603/S2, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Approval Date: August 13, 1999


FDA Clears Genetic Test That Advances Personalized Medicine Today, FDA cleared for marketing a new blood test that will help doctors make personalized drug treatment decisions for some patients. The Invader UGT1A1 Molecular Assay detects variations in a gene that affects how certain drugs are broken down and cleared by the body. Doctors can use this information to help determine the right drug dosage for individual patients, and minimize harmful drug reactions.

Dangerous Prescription

Watch the

Full Program Online 

A look inside the FDA, its recent record, and the debate over whether our nation's drug safety system is broken.

Plus, FAQs and links for consumers.



A biostatistician, Michael Elashoff was a drug reviewer for the FDA from 1995 to 2000. Elashoff says he found himself marginalized at the FDA after he voiced his concerns about a new flu drug called Relenza. In this interview, Elashoff speaks out about the culture of the FDA's drug approval process and why he felt Relenza should not have been put on the market. This interview was conducted on Feb. 19, 2003.


FDA  --  U.S. Department of Health & Human Services

Information about the Products the FDA Regulates

FDA's counsel accused of being too close to drug industry

Daniel Troy, chief counsel to the US Food and Drug Administration, is under fire for inviting drug companies to inform him of lawsuits against them so the FDA could help in their defense.  Jeanne Lenzer New York  BMJ 2004;329:189 (24 July), doi:10.1136/bmj.329.7459.189;  Produced by BMJ Publishing Group Ltd of the BMA, assisted by Stanford University's HighWire Press.

Strong majority of FDA scientists feel agency does poor job of monitoring drugs on market

WASHINGTON_About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
AP Alert - Michigan


New Worries About Drug Safety

NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.

  • Rising Prescription Drug Use Corresponds to Increase in Stevens Johnson Syndrome; SJS Foundation Issues Warning Signs

Described in many drug warning inserts as a "serious skin condition," SJS is actually a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases.

An under-reported and under-recognized condition, people develop SJS from commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including Dilantin Cerebellar Atrophy Risks drugs such as adult and children ibuprofen products. Because many physicians and emergency facilities are not familiar with the symptoms, treatment is frequently delayed, further exacerbating the condition.

To recognize SJS in its earliest stage, the SJS foundation urges patients and physicians to watch for the following symptoms when taking medications:

-- Persistent fever
-- Burning or blistering of the mucous membranes, i.e.: eyes, ears, mouth, nose, genital area.
-- Rash, blisters or red splotches on skin
-- Flu-like symptoms
-- History of a reaction to prescribed drugs or Dilantin Cerebellar Atrophy Risks medications.

In one estimate, SJS is reported to effect three to eight people per million per year in the U.S. However, the frequency could be much higher since only one percent of adverse drug reactions is reported, according to the Food and Drug Administration.

"SJS is not as rare as we are led to believe," said Jean McCawley, president of the SJS Foundation. "As prescription drug use increases, we are being contacted by increasing numbers of people. During the winter months, we learn of 15 new cases a week, and that's only people with Internet access."

About SJS Foundation

Founded in 1995, the Stevens Johnson Syndrome Foundation (Julie Foundation for allergic drug reactions) is a non-profit organization that provides information and support for victims, educates the medical community and encourages research in preventing adverse drug reactions. More information is available at www.sjsupport.org

    Healing Well
  • New Treatment for Acute Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
    Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are moderate and severe variations of the same adverse reaction (usually to drugs or mycoplasma pneumonia) which result in blistering and sloughing of skin and mucosal membranes, and carry a high risk of mortality
  • Stevens-Johnson syndrome plus toxic hepatitis due to ibuprofen, PubMed, National Library of Medicine, New York State Journal of Medicine July;78(8):1239-43, Sternlieb P, Robinson RM.  Nassau Hospital, Mineola, New York
  • Introital adenosis associated with Stevens-Johnson syndrome, PubMed, National Library of Medicine, Obstet Gynecol 1985 Jul;66(1):143-5, Marquette GP, Su B, Woodruff JD.
    A 23-year-old woman presented with vulvar pain and dyspareunia 1.5 years after a Stevens-Johnson syndrome. A red friable lesion was identified at the vestibule and lower third of the vagina. The histologic diagnosis was adenosis with a tubal glandular epithelium. The possible histogenesis of this lesion is discussed with a review of the embryology of the lower genital tract.
  • Rehabilitative considerations for patients with severe Stevens-Johnson syndrome or toxic epidermal necrolysis. A case report.  PubMed, National Library of Medicine, J Burn Care Rehabil 1989 Mar-Apr;10(2):167-71, K. McDonald, PT, B. Johnson, PT, J.K. Prasad, MD, and P. D. Thomas, PhD.  University of Michigan Medical Center, Physical Therapy Division, Ann Arbor 48109-0046.
  • Vitamin A in Stevens-Johnson Syndrome, PubMed, National Library of Medicine, Ann Ophthalmol 1989 Jun;21(6):209-10, Singer L, Brook U, Romem M, Fried D., Department of Ophthalmology, Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Unusual manifestation of Stevens-Johnson syndrome involving the respiratory and gastrointestinal tract., PubMed, National Library of Medicine, Pediatrics 1992 Mar;89(3):429-32, Dean S. Edell, MD MPH; James J. Davidson; Andre A. Muelenaer, MD; Marc Majure, MD; Department of Pediatric Pulmonary, Duke University School of Medicine, Durham, NC.

  • Neuropathy in burn patients., PubMed, National Library of Medicine, Brain 1993 Apr;116 ( Pt 2):471-83, Sean Marquez; J. Jean E. Turley; Walter J. Peters; Department of Medicine, Division of Neurology and the Department of Surgery, Division of Plastic Surgery, Wellesley Hospital, Toronto, Canada.

  • Burn-associated peripheral polyneuropathy. A search for causative factors. PubMed, National Library of Medicine, American Journal Physical Medicine Rehabilitation 1995 Jan-Feb;74(1):28-32, Anthony J. Margherita, MD; Lawrence R. Robinson,MD; David M. Heimbach, MD; Vicki L. Fishfader,BS; Vicki A. Schneider, MS;  Dana Jones,BS.  Department of Rehabilitation Medicine, Harborview Medical Center/University of Washington School of Medicine, Seattle 98195.
  • Analysis of the Acute Ophthalmic Manifestations of the Erythema Multiforme/Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Disease Spectrum., PubMed, National Library of Medicine, Ophthalmology 1995 Nov;102(11):1669-76, William J. Power, FRCS, FRCOphth;  Mohammed Ghoraishi, MD;  Jesus Merayo-Lloves, MD;   Renato A. Neves, MD;  C. Stephen Foster, MD, FACS.  Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston 02114, USA.  Presented at the American Academy of Ophthalmology Annual Meeting.
  • Acute and Chronic Respiratory Complications of Toxic Epidermal Necrolysis., PubMed, National Library of Medicine, J Burn Care Rehabilitation 1996 May-Jun;17(3):237-40, R.A. McIvor, MD;  J. Zaidi, MD;  W. J. Peters, MD;  R.H.Hyland, MD.  Division of Respirology, University of Toronto, and the Ross Tilley Burn Centre, Wellesley Hospital, Toronto, Ontario, Canada.
  • Bronchiolitis obliterans in children with Stevens-Johnson syndrome: follow-up with high resolution CT., PubMed, National Library of Medicine, Pediatrics Radiology 1996;26(1):22-5, M.J. Kim and K.Y. Lee.  Department of Diagnostic Radiology, Severance Hospital, 134 Seodaemoon-gu, Shinchon-dong, Seoul 120-752, Korea.

  • < Vulvovaginal sequelae in toxic epidermal necrolysis., PubMed, National Library of Medicine, The Journal of Reproductive Medicine 1997 Mar;42(3):153-6, Eric Meneux, MD;  Bernard J. Paniel,MD; Florence Pouget,MD;  Jean Revuz,MD;  Jean-Claude Roujeau, MD;  Pierre Wolkenstein, MD.  Department of Gynecology, Centre Hopitalier Intercommunal, and the Department of Dermatology, Hospital Henri Mondor, Creteil, France.

  • Drug-associated acute-onset vanishing bile duct and Stevens-Johnson syndromes in a child.  PubMed, Srivastava M, Perez-Atayde A, Jonas MM.  Combined Program in Gastroenterology, Department of Medicine, Children's Hospital, Boston, Massachusetts, USA., Gastroenterology. 1998 Sep;115(3):743-6.PMID: 9721172.

  • Esophageal Involvement in Stevens-Johnson Syndrome., PubMed, National Library of Medicine, Endoscopy 2001 Jun;33(6):550-3, Lamireau T, Leaute-Labreze C, Le Bail B, Taieb A., Division of Pediatric Gastroenterology, Children 's Hospital, Bordeaux, France. thierry.lamireau@chu-bordeaux.fr.  Division of Pediatric Dermatology, Children's Hospital, Bordeaux, France, Laboratory of Pathology, Pellegrin's Hospital, Bordeaux, France.

  • Neuropathy after burn injury., PubMed, National Library of Medicine, J Burn Care Rehabilitation 2001 Sep-Oct;22(5):353-7; discussion 352, K. Kowalske, MD;  R. Holavanahalli, PhD; P. Helm, MD.  Department of Physical Medicine and Rehabilitation, University of Texas Southwestern Medical Center at Dallas, 75390-9055, USA.


  • Stevens-Johnson Syndrome and Cholestatic Hepatitis., PubMed, National Library of Medicine, Digestive Diseases and Sciences, Vol. 46, No. 11 (November 2001):2385-8, Michael S. Morelli, MD and Francis X. O'Brien, MD.  Department of Internal Medicine, Section of General Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, USA.

  • Intravenous ulinastatin therapy for Stevens-Johnson syndrome and toxic epidermal necrolysis in pediatric patients. Three case reports., PubMed, National Library of Medicine, Int Arch Allergy Immunol 2002 Jan;127(1):89-94, Inamo Y, Okubo T, Wada M, Fuchigami S, Hashimoto K, Fuchigami T, Takahashi S, Sawada S, Harada K, Department of General Pediatrics, Nihon University Nerima-Hikarigaoka Hospital, Nihon University School of Medicine, Tokyo, Japan. y-inamo@pb3.so-net.ne.jp


  • Effect of high-dose intravenous immunoglobulin therapy in Stevens-Johnson syndrome, Dermatology. 2003;207(1):96-9.
    PMID: 12835566 [PubMed - indexed for MEDLINE]; Prins C, Vittorio C, Padilla RS, Hunziker T, Itin P, Forster J, Brocker EB, Saurat JH, French LE. 
    BACKGROUND:Stevens-Johnson syndrome (SJS) is a severe cutaneous drug reaction associated with considerable morbidity, possible transition to toxic epidermal necrolysis (TEN) and death in certain cases.


  • Use of intravenous immunoglobulin in children with Stevens-Johnson syndrome and toxic epidermal necrolysis: seven cases and review of the literature, Pediatrics. 2003 Dec;112(6 Pt 1):1430-6. Review. PMID: 14654625 [PubMed - indexed for MEDLINE]; Metry DW, Jung P, Levy ML.;  Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis are the most severe cutaneous reactions that occur in children.