Lawyers file most isotretinoin adverse drug reports

Lawyers file most isotretinoin adverse drug reports

(HealthDay)—Attorneys have submitted a disproportionate number of isotretinoin-associated inflammatory bowel disease (IBD) cases to the U.S. Food and Drug Administration, according to a study published in the September issue of the Journal of the American Academy of Dermatology.

Derrick J. Stobaugh, from the Center for the Study of Complex Diseases in Evanston, Ill., and colleagues analyzed data from the FDA Adverse Event Reporting System (FAERS) to identify IBD cases reported with isotretinoin for a usage indication of . Reporter category was recorded. The distortion of pharmacovigilance signals for IBD with isotretinoin were determined with the signal inflation factor calculation.

The researchers found that there were 2,214 cases of IBD resulting from isotretinoin, with attorneys reporting 87.8 percent of cases (1,944), physicians reporting 6 percent (132 cases), and consumers reporting 5.1 percent (112 cases). For the same time period, only 3.6 percent of all reported to the FAERS were reported by attorneys (87,905 of 2,451,314). The signal inflation factor for isotretinoin-associated IBD for attorney-initiated reports was 5.82, signifying a clear distortion.

"Attorney-initiated reports inflate the pharmacovigilance signal of isotretinoin-associated IBD in the FAERS," the authors write.

More information: Abstract
Full Text (subscription or payment may be required)

add to favorites email to friend print save as pdf

Related Stories

Inflammatory bowel disease raises risk of melanoma

May 20, 2013

Patients with inflammatory bowel disease (IBD) are at higher risk of melanoma, a form of skin cancer, report researchers at Mayo Clinic. Researchers found that IBD is associated with a 37 percent greater risk for the disease. ...

Flu vaccine safe for children with IBD, study shows

May 06, 2013

Influenza immunization rates in children with inflammatory bowel disease (IBD) are low despite its safety according to a new study by researchers at the Institute for Clinical Evaluative Sciences (ICES), Children's Hospital ...

Recommended for you

Boxed warnings are common in novel therapeutics

Aug 19, 2014

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

AstraZeneca says DOJ closes probe into drug trial

Aug 19, 2014

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.

Perampanel for epilepsy: Still no proof of added benefit

Aug 19, 2014

The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment ...

User comments