Ugh...sorry to be the bearer of bad news, but at least it looks like these serious side effects are rare!
March
18, 2008 — Serious skin reactions have been reported with tumor
necrosis factor (TNF)–alpha antagonists, according to a March 18 US
Food and Drug Administration (FDA) Drug Safety Newsletter. "Safety reviews of [TNF-alpha] antagonists, infliximab [Remicade, Centocor Inc], etanercept [Enbrel, Manufactured by Immunex Corporation; marketed by Amgen and Wyeth Pharmaceuticals], and adalimumab [Humira,
Abbott] identified rare cases of serious skin reactions, including
erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic
epidermal necrolysis (TEN), associated with the use of these biological
products," the newsletter states. "The product labeling for infliximab
has been updated to describe postmarketing reports of serious skin
reactions. [The] FDA is continuing to analyze what, if any, revisions
to product labeling are needed for etanercept and adalimumab." In the interim, the FDA advises healthcare professionals and
patients to monitor for skin reactions associated with the use of these
TNF-alpha antagonists and to report cases to FDA's MedWatch. The serious skin reactions presented mostly with rash and skin
lesions on the trunk, limbs, shoulder, back, hands, and face. In some
SJS cases, oral mucositis or ulceration, genital ulceration, and/or
fever were also reported. An allergic-type reaction occurred in 1
patient who first had hives and swollen lips, eyes, and face, followed
by EM lesions on her back and hypoxia. In a few cases of TEN, the skin reactions consisted of desquamation
and progressive, generalized pruritus and skin peeling; a severe,
scaly, pigmented, necrotizing rash over the body; and erythema with
blepharoconjunctivitis, angioedema, and tightness in the throat. The newsletter describes in detail 3 cases showing a clear temporal
relationship between treatment with TNF-alpha antagonists and onset of
serious skin reactions. From approval in August 1998 to August 2006, the FDA received 21
reports of cases in adult patients of severe cutaneous adverse
reactions associated with infliximab, including 16 postmarketing
reports and 5 study/registry cases. These included 15 cases of EM, 5
cases of SJS, and 1 case of TEN. Three quarters of the patients (76%)
were female; 62% had received infliximab for the treatment of
rheumatoid arthritis. Median time to onset between first infusion and
onset of skin reaction was 28 days; median number of infusions before
the skin reaction was 2 (range, 1 – 6). Twelve patients required hospitalization for skin reactions
associated with infliximab; 1 patient hospitalized with TEN
subsequently died of multiorgan system failure 20 days after the first
infusion. "Despite confounding factors, such as concomitant medications which
have been associated with skin reactions, several cases reported to
[the FDA's Adverse Event Reporting System] described a plausible
temporal relationship, positive dechallenge, and/or positive
rechallenge supporting an association between infliximab and serious
cutaneous skin reactions," the newsletter notes. From approval in November 1998 to November 2006, the FDA received 22
reports of cases of severe skin reactions linked to etanercept. There
were 13 reports of EM, 4 of TEN, 4 of SJS, and 1 of SJS/TEN; 64% were
female, and most had received etanercept for the treatment of
rheumatoid arthritis. In 2 cases for which time to onset since last
etanercept dose was provided, this time was 5 days and 9 days,
respectively. Despite limited data on the start/stop dates of
concomitantly used medications, most reported a temporal relationship
with etanercept use. Eleven patients required hospitalization, and 1
died with leukemia and EM. From approval in December 2002 to November 2006, the FDA received 7
reports of severe cutaneous reactions linked to adalimumab: 4 of EM, 2
of SJS, and 1 of both EM and SJS. Five patients (71%) had used
adalimumab for treatment of rheumatoid arthritis; 85% were female.
Median time to onset from starting adalimumab to skin reaction was 60
days. One patient was hospitalized, and there were no reported deaths. "As protein products, all three TNF-[alpha] antagonists are
potentially immunogenic and could precipitate immune-mediated serious
skin reactions such as EM, SJS, and/or TEN," the newsletter concludes.
"Evaluating the association between TNF-[alpha] antagonists and serious
skin reactions can be challenging due to confounding factors, such as
co-administration of one or more medications associated with EM, SJS,
and/or TEN.... The development of any severe skin reaction while
receiving TNF-[alpha] antagonist therapy may require a work-up to
determine the appropriate diagnosis and treatment and consideration of
an alternative therapy." I'm sure there are a lot of good reasons to post that you didn't have rare side effects. Since they are rare, it would be common not to have them. That is why everybody is posting about the rare side effects they did not have.
http://www.medscape.com/viewarticle/571633
Serious Skin Reactions Reported With TNF-Alpha Antagonists
Didn't someone post here about getting a rash on her ankles and calling the drug maker's nurseline to ask about it, and they called her dr. and made him stop rx'ing it? I remember she was upset, because the med was helping her RA.
I might be able to say something when I go onto one of them in a month or so.
You're welcome Stephen, I'm always happy to share. I'll be interested in hearing about your experiences with a biologic. There seems to be quite a wide range..
Take care,
Lynn
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