Topical Lidocaine Comes With Risks_ Warns FDA

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					10          NEWS                                                                                                                   FEBRUARY 2009 • SKIN & ALLERGY NEWS

Bimatoprost Approved for Eyelash Lengthening
          B Y E L I Z A B E T H M E C H C AT I E              weeks after the FDA’s Dermatologic and Ophthalmic centage] of hairs in, and the duration of, the anagen or
                       Senior Writer                          Drugs Advisory Committee met to review bimatoprost growth phase,” according to the labeling. Eye pruritus,
                                                              for the cosmetic indication. The panel unanimously conjunctival hyperemia, and skin hyperpigmentation
        he Food and Drug Administration has approved          agreed that the benefit-risk profile of bimatoprost for are listed in the label as the most common adverse

T       bimatoprost for increasing the growth of eye-
        lashes, a side effect of the glaucoma-treating
drug that was first observed several years ago in clini-
                                                              hypotrichosis of the eyelashes
                                                              was favorable.
                                                                The panel decision was based
                                                                                                      The new indication is for
                                                                                                      ‘the treatment of
                                                                                                                                               events, affecting about 3%-4% of
                                                                                                                                               people treated. Warnings include
                                                                                                                                               the possibility of pigmentation of
cal trials.                                                   on the efficacy data in a study                                                  the iris (which is likely to be per-
   The new indication for bimatoprost 0.03% ophthalmic        comparing bimatoprost with a            hypotrichosis of the                     manent) and the eyelids.
solution is for “the treatment of hypotrichosis of the eye-   control vehicle in 278 people                                                      Allergan has agreed to conduct
lashes by increasing their growth including length, thick-    (aged 22-78 years) with hypotri-
                                                                                                      eyelashes by increasing                  a 4-month, randomized, con-
ness and darkness.” It will be marketed under the trade       chosis of the eyelashes, as well as     their growth.’                           trolled study of bimatoprost so-
name Latisse by Allergan Inc., which markets the same         a large bimatoprost safety data-                                                 lution in at least 50 black subjects,
product (Lumigan) for treating intraocular pressure in pa-    base (SKIN & ALLERGY NEWS, January 2009, p. 1).            according to the FDA’s approval letter. The one black
tients with open angle glaucoma or ocular hypertension.         After 16 weeks, 78% of those in the bimatoprost patient in the hypotrichosis study was in the vehicle
Lumigan was approved for glaucoma in 2001.                    group had at least a 1-point increase on a scale that mea- group. Another postmarketing requirement is that the
   Unlike Lumigan, which is administered directly in the      sured eyelash prominence (the primary efficacy end company conduct a study of the safety and efficacy of
eye, Latisse is applied at night to the skin of the upper     point), compared with 18% of those on the vehicle, a bimatoprost in patients aged 0-17 years with hypotri-
eyelid margin at the base of the eyelashes using a dis-       statistically significant difference.                      chosis.
posable applicator (one for each eye), which is to be           Exactly how bimatoprost, a prostaglandin analog,           Allergan plans to launch Latisse in the first quarter
used only once.                                               promotes eyelash growth has not been determined, but of 2009, according to a written statement from the
   The new indication was approved on Dec. 26, 3              growth “is believed to occur by increasing the [per- company.                                                       ■

Anti-TNF, Birth Defect Link                                                                                       Topical Lidocaine Comes
Controversy Fueled by Study                                                                                       With Risks, Warns FDA
                                                                                                                        BY ELIZABETH                  premedicated with 4% lido-
             BY DENISE NAPOLI                           Baylor Research Institute in Dallas.                              M E C H C AT I E            caine gel, than among those
                  Associate Editor                         The review of the FDA adverse events database,                  Senior Writer              premedicated with aceta-
                                                        led by Dr. John D. Carter, involved more than                                                 minophen or ibuprofen.
      ata from a Food and Drug Administration           120,000 adverse events for all entries between 1999            he use of topical lidocaine       In the study, topical lido-
D     registry suggesting an increase in birth de-
fects among women treated with etanercept and
                                                        and 2005 found with the keywords “congenital
                                                        anomaly,” “congenital anomalies,” “birth defect,”
                                                                                                                  T    products to mitigate pain
                                                                                                                  has the potential to cause life-
                                                                                                                                                      caine was spread over a wide
                                                                                                                                                      area and covered with plastic,
infliximab have rekindled controversy over the use      and “birth defects.” A total of 41 children with 61       threatening events, according       and no serious adverse effects
of tumor necrosis factor blockers in pregnancy.         congenital anomalies born to 40 different moth-           to a public health advisory is-     were reported. But the FDA
   Authors of a new review of FDA data advise           ers who were taking a TNF antagonist during               sued by the Food and Drug           statement points out that the
clinicians against prescribing anti-TNF agents to       pregnancy were recorded ( J. Rheumatol. 2008              Administration Jan. 16.             study was not large enough to
pregnant women based on their findings that             Dec. 15 [doi:10.3899/jrheum. 080545]).                       “Before recommending a           determine whether this use
etanercept and infliximab may be responsible for           Overall, 22 of these mothers had been taking           topical anesthetic for any pur-     could be associated with un-
a “seemingly high number” of congenital anom-           etanercept at some point during their pregnancy;          pose, doctors should deter-         common, serious reactions,
alies. “Clinicians should not prescribe TNF an-         19 had been taking infliximab. “In all 41 cases, the      mine if the desired amount of       and adds that the agency “re-
tagonists to women during pregnancy,” wrote the         TNF-α antagonist was considered the ‘primary              pain relief can be achieved safe-   mains concerned about the
authors of the review.                                  suspect’ as the cause of the birth defect,” wrote         ly with a topical anesthetic or     potential for topical anesthet-
   However, conflicting preliminary data from an        Dr. Carter of the division of rheumatology at the         if a different treatment would      ics to cause serious and life-
ongoing study by the Organization of Teratology         University of South Florida, Tampa.                       be more appropriate,” the FDA       threatening adverse effects
Information Specialists (OTIS) argue that                  A total of 34 different types of birth defects         alert says. If a topical anes-      when applied to a large area of
anti–tumor necrosis factor agents are safe for this     were seen, 19 of which were part of the VAC-              thetic is considered the best       skin or when the area of ap-
population. Dr. Christina Chambers, a coinvesti-        TERL spectrum.                                            choice, the lowest amount nec-      plication is covered.”
gator on the OTIS study, said it was alarmist to           In an interview, Dr. Chambers took issue with          essary to adequately relieve           When a topical anesthetic is
recommend avoiding anti-TNF agents in preg-             the VACTERL findings, noting that to include              pain should be used, the            recommended, patients need
nancy, and said that reviews of the FDA adverse         children’s defects as part of the VACTERL spec-           agency recommends.                  to apply the product sparing-
events database are “inherently biased.” Based on       trum means that they must exhibit at least three             The advisory does not men-       ly, should avoid broken or ir-
her group’s results, she said, “We’re not able to       of the seven defects in the spectrum—not just             tion any reports of adverse         ritated skin; and should be
draw any conclusions that suggest that we are see-      one. And though the authors emphasize that 24             events associated with the use      counseled that the risk of ad-
ing any specific pattern of defects, whether ma-        of 41 children (59%) “had one or more congeni-            of topical anesthetics in this      verse effects is increased when
jor or minor, based on the children that have been      tal anomalies that are part of VACTERL,” only             context, but refers to a Febru-     a wrapping or dressing is used
evaluated so far.”                                      one was diagnosed with the pattern of associat-           ary 2007 FDA advisory that de-      to cover the skin, the adviso-
   Dr. John J. Cush, who is not involved with ei-       ed birth defects within the original study period,        scribed two young women             ry recommends.
ther of these studies but who has conducted his         according to Dr. Chambers.                                who died after applying a top-         In the 2007 alert, the FDA
own surveys on the issue, said in an interview that        Dr. Carter said that he thinks women of child-         ical anesthetic to their legs af-   said that in two separate inci-
“the FDA database serves an important role in           bearing age taking anti-TNFs should be strongly           ter laser hair removal—and to       dents, women in their 20s had
providing insight into what may be a potential          encouraged to use contraception, as they are              a recently published study that     seizures and went into comas
hazard to those receiving these drugs.”                 with known teratogenic drugs such as Accutane.            evaluated the effect of lido-       after applying topical products
   However, he added, “There are biases regarding          Dr. Carter did not declare any conflicts of in-        caine in relieving discomfort       that contained a high concen-
underreporting, sources of reports, the lack of a de-   terest with regard to his study. Dr. Chambers said        during mammograms (Radi-            tration of lidocaine and tetra-
nominator, and a grossly underestimated numer-          she did not have any personal conflicts, but that         ology 2008;248:765-72).             caine to their legs, and wrapped
ator.” Of course, all databases—including the OTIS      OTIS receives grant funding from nine different              In the study of 418 women        their legs in plastic wrap to in-
database—have inherent biases, he cautioned.            pharmaceutical companies, two of which are                aged 32-89 undergoing a             crease the anesthetic effects. ■
   “Nonetheless, there is no reason or convincing       manufacturers of anti-TNFs. Dr. Cush has served           screening mammogram, who
data to emphatically deny effective anti-TNF ther-      as a consultant or advisor to, or received grant          expected to experience dis-         The advisory is available at:
apy to patients who need it to control their disease,   money from, multiple pharmaceutical compa-                comfort during the test, dis-
either before or during pregnancy,” said Dr. Cush,      nies, including the makers of the three anti-TNFs         comfort was significantly low-      advisory/topical_anesthetics
director of the clinical rheumatology program at        looked at in these studies.                        ■      er among those who were             2009.htm.

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