A review of adverse event data associated with the synthetic vitamin A retinoid isotretinoin between 1997 and 2002 suggests that the acne treatment is a "probable" cause of inflammatory bowel disease (IBD) and may precipitate its presentation within a certain subset of patients who are either predisposed to the disease or have subclinical symptoms.
A review of adverse event data associated with the synthetic vitamin A retinoid isotretinoin between 1997 and 2002 suggests that the acne treatment is a "probable" cause of inflammatory bowel disease (IBD) and may precipitate its presentation within a certain subset of patients who are either predisposed to the disease or have subclinical symptoms.
"We do not think that this should prohibit the use of isotretinoin, but careful consideration should be made in those patients at higher risk for IBD or with symptoms suggestive of IBD," the researchers stated.
Investigators gathered reports of adverse events associated with isotretinoin from FDA's MedWatch program and used the Naranjo adverse drug reaction (ADR) probability scale to evaluate whether a causal relationship existed between isotretinoin treatment and presentation of IBD. Eighty-five cases of patients presenting with IBD after isotretinoin use were identified and examined.
After applying the Naranjo probability scale, researchers found 4 cases achieving scores in the "highly probable" range of a causal relationship between isotretinoin treatment and IBD. "Probable" scores were obtained by 58 cases (68%), and 23 cases (27%) scored in the "possible" range. No case scored in the "doubtful" range.
Retinoids trigger diverse biological activity, such as natural killer T-cell stimulation, disturbed epithelial tissue growth, disruption of glycoprotein synthesis, apoptosis, or effects of expressing growth factors, prostaglandins, or tumor necrosis factor. These mechanisms or others associated with isotretinoin may serve to trigger IBD in patients who have a prior personal history or a family history of the disease or cause the unmasking of symptoms in patients with preexisting, subclinical disease, the study authors stated.
The results should be approached with caution, however, because of the age of the subjects, the authors stated, noting that the peak age of IBD onset is during young adulthood, when most people receive treatment for acne.
"Although the temporal relationship between isotretinoin use and onset of IBD is convincing in many of the reported cases, it is impossible to be certain that this is not coincidence," the authors stated.
Other study limitations include the unconfirmed nature of the data quality provided by MedWatch and that postmarketing research data is "notoriously" poor with only 1% of serious adverse reactions reported, according to the authors.
SOURCE Reddy D, Siegel CA, Sands BE, Kane S. Possible association between isotretinoin and inflammatory bowel disease. Am J Gastroenterol. 2006;101:1569–1573.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
Joseph Zabinski Advocates for Patient Trust in AI Adoption in Dermatology Care
April 18th 2024Joseph Zabinski, PhD, MEM, vice president, head of commercial strategy and AI, OM1, chatted with MHE editors on the significance of patient acceptance in AI adoption in healthcare, overall and in the dermatology space, stressing trust and transparency.
Read More