Casemed-pregnancy resource newsletter

CaseMe d-P regnanc y Resource News le tter
December 20 07
MEDICAL STUDIES

Two successful pregnancies in chronic myeloid leukemia patient treated with imatinib
Garderet L, Santacruz R, Barbu V, et al
Haematologica, 2007; 92(1): e9-10
According to the authors, physicians do not know when to stop imatinib treatment in women with
CML or know what the risks are for the fetus and the mother. Garderet and colleagues present a
case of a CML patient treated with imatinib who has two healthy children, now 3 years and 10
months of age. The mother was in complete molecular remission, relapsed during pregnancy and
reverted to remission in both cases after delivery.
Atrial and ventricular rate response and patterns of heart rate acceleration during maternal-
fetal terbutaline treatment of fetal complete heart block.
Cuneo BF, Zhao H, Strasburger JF, et al
Am J Cardiol, 2007; 100(4): 661−5
Terbutaline is used to treat fetal bradycardia in the setting of complete heart block (CHB);
however, little is known of its effects on atrial and ventricular beat rates or patterns of heart rate
(HR) acceleration. This study compared fetal atrial and ventricular beat rates before and after
transplacental terbutaline treatment (10 to 30 mg /day) by fetal echocardiography in 17 fetuses
with CHB caused by immune-mediated damage to a normal conduction system or a congenitally
malformed conduction system associated with left atrial isomerism. While receiving terbutaline, 9
of the 17 fetuses underwent fetal magnetocardiography to assess maternal HR and rhythm,
patterns of fetal HR acceleration, and correlation between fetal atrial and ventricular accelerations
(i.e., AV correlation). The researchers conclude that the pathophysiologic heterogeneity of CHB
is reflected in the differing effect of terbutaline on the atrial and ventricular pacemaker(s) and
varying patterns of HR acceleration. However, regardless of the cause of CHB, terbutaline
augments HR but not AV correlation, suggesting that its effects are determined by the conduction
system defect rather than the autonomic control of the developing heart.
Risks of congenital malformations and perinatal events among infants exposed to
antidepressant medications during pregnancy
Davis RL, Rubanowice D, McPhillips H, et al
Pharmacoepidemiol Drug Saf, 2007; 16(10): 1086−94
The purpose of this study was to evaluate risks for perinatal complications and congenital defects
among infants exposed in utero to antidepressants. The researchers identified 2201 women who
were prescribed an antidepressant during pregnancy and who delivered an infant within one of
five large managed care organizations. Rates of congenital anomalies or perinatal complications
were compared to infants whose mothers were not prescribed antidepressants during pregnancy.
Results showed that Selective Serotonin Reuptake Inhibitors (SSRIs) and Tricyclic
Antidepressants (TCAs) did not show a consistent link with congenital anomalies. The risk of
preterm delivery was found to increase in infants exposed to antidepressants. The authors
conclude that both SSRIs and TCAs used during the third trimester appeared to increase the risk
for perinatal complications and their use should be managed carefully among pregnant women
with depression.
Fetal malformations associated with mycophenolate mofetil for lupus nephritis
El Sebaaly Z, Charpentier B, Snanoudj R
Nephrol Dial Transplant, 2007; 22(9): 2722
No abstract is available.

Randomized comparison of intravenous terbutaline vs nitroglycerin for acute intrapartum fetal
resuscitation
Pullen KM, Riley ET, Waller SA, et al
Am J Obstet Gynecol, 2007; 197(4): 414.e1−6
The purpose of this study was to compare terbutaline and nitroglycerin for acute
intrapartum fetal resuscitation. One hundred and ten women had nonreassuring fetal heart rate
tracings in labor; 57 women received terbutaline, and 53 women received nitroglycerin. The
researchers conclude that while terbutaline provided more effective tocolysis with less impact on
maternal blood pressure, no difference was noted between nitroglycerin and terbutaline in
successful acute intrapartum fetal resuscitation.
Pharmacology of antiepileptic drugs during pregnancy and lactation
Pennell PB, Gidal BE, Sabers A, et al
Epilepsy Behav, 2007; 11(3): 263-9
Most women with epilepsy require continuous treatment during pregnancy, making antiepileptic
drugs (AEDs) one of the most frequent chronic teratogen exposures. Therapeutic decisions should
balance the risks to the developing fetus of AED exposure and of not treating or undertreating the
epilepsy. The International AED Pharmacology Work Group of the Health Outcomes in
Pregnancy and Epilepsy (HOPE) Forum identified four pharmacology topics critical to enhancing
maternal and fetal outcomes for pregnancies exposed to AEDs: (1) hormonal therapies and
endogenous changes: bidirectional interactions with AEDs; (2) pharmacokinetic alterations
during pregnancy, the role of therapeutic drug monitoring, and the influence on seizure control
and maternal and fetal outcomes; (3) multidrug transporters and their various roles during
pregnancy; (4) breastfeeding in mothers taking AEDs. The report provides an overview of these
key topics, highlights gaps in the current knowledge, and provides future directions for needed
research.
Antiepileptic drug exposure and major congenital malformations: the role of pregnancy
registries
Tomson T, Battino D, French J, et al
Epilepsy Behav, 2007; 11(3): 277-82

The use of antiepileptic drugs (AEDs) in pregnancy is associated with an increased risk of fetal
malformations. Although it is known that AEDs may differ with respect to the type of
malformations they can induce, earlier studies have generally lacked the power to demonstrate
differences between AEDs in their overall teratogenic potential. Furthermore, there is an urgent
need to assess the clinical teratogenic potential of the newer-generation AEDs. Epilepsy and
pregnancy registries have been established to provide such information, which is essential for the
rational management of women with epilepsy with childbearing potential. This review provides a
critical discussion and comparison of important methodological aspects for AED and pregnancy
registries along with a summary of results published so far.

Teratology public affairs committee position paper: Pregnancy labeling for prescription drugs:
Ten years later
Public Affairs Committee of the Teratology Society
Birth Defects Res A Clin Mol Teratol, 2007; 79(9): 627-30
No abstract is available.

Selection of controls in case-control studies on maternal medication use and risk of birth
defects
Bakker MK, de Walle HE, Dequito A, et al
Birth Defects Res A Clin Mol Teratol, 2007; 79(9): 652-6

According to the authors, in case-control studies on teratogenic risks of maternal drug use during
pregnancy, the use of normal or malformed controls may lead to recall-bias or selection bias. This
can be avoided by using controls with a genetic disorder. However, researchers are hesitant to use
these as controls because it is unknown whether their selection is independent of exposure status.
The aim of this study was to investigate whether first trimester drug use among mothers of
children with genetic disorders is representative for the "general pregnant population". Bakker
and colleagues conclude that with the exception of antimigraine medication, first trimester drug
use among mothers of infants with genetic disorders is representative for the general pregnant
population.
New cases of thalidomide embryopathy in Brazil
Schuler-Faccini L, Soares RC, de Sousa AC, et al
Birth Defects Res A Clin Mol Teratol, 2007; 79(9): 671-2
While thalidomide is the best known human teratogen, it also has a potent immunomodulatory
property which has allowed it to be used for a number of approved and off-label uses in
dermatologic, oncologic, infectious and gastrointestinal conditions. No cases of thalidomide
embriophaty have been recorded in the U.S. or Latin America since 1998 and 1996 respectively.
However, the Teratogen Information Service (TIS) Porto Alegre, recorded three new cases of
thalidomide embriophaty born in Brazil since 2005. Considering that these three cases were not
registered through a systematic surveillance system, but that came to the authors’ attention
through a series of coincidental random events, it can be assumed that the actual occurrence of
affected babies by thalidomide continues being as frequent as denounced ten years ago.

Maternal fish oil supplementation in pregnancy modifies neonatal leukotriene production by
cord-blood-derived neutrophils
Prescott SL, Barden AE, Mori TE, et al
Clin Sci, 2007; 113(10): 409-16
The objective of this study was to examine the effects on neonatal neutrophil function following
supplementation in pregnancy. Pregnant women with allergic disease were randomized to receive
either fish oil (3.7 g of n−3 long−chain PUFAs (polyunsaturated fatty acids) /day) or a placebo
supplement for the final 20 weeks of pregnancy. Leukotriene production by neonatal neutrophils
was measured after stimulation with the calcium ionophore A23187. This was examined in
relation to supplementation, cell membrane fatty acid levels and mononuclear cytokine
production. Prescott and colleagues conclude that maternal dietary changes can modify neonatal
neutrophil function. This has implications for the early immune programming, which can be
influenced by the inflammatory milieu of local tissues during initial antigen encounter. It also
provides evidence of another pathway through which long-chain PUFAs status can influence
early immune development.
Early elective insulin therapy can reduce hyperglycemia and increase insulin-like growth
factor-I levels in very low birth weight infants
Beardsall K, Ogilvy-Stuart AL, Frystyk J, et al
J Pediatr, 2007; 151(6): 611-7
The objective of this study was to investigate the use of insulin throughout the first week of life in
very low birth weight (VLBW) infants (birth weight <1.5 kg) to improve glucose control and
increase insulin-like growth factor-I (IGF-I) levels. IGF-I is the dominant hormone involved in
fetal growth, and low levels have been implicated in neonatal morbidities, such as retinopathy of
prematurity. The authors conclude that early insulin therapy improves blood glucose control and
increases IGF-I bioactivity levels. This could result in less morbidity associated with
hyperglycemia and reduced IGF-I levels.
Reduction of HIV-1 drug resistance after intrapartum single-dose nevirapine
Lockman S, McIntyre JA
Lancet, 2007; 370(9600): 1698-705
No abstract is available.
Single-dose tenofovir and emtricitabine for reduction of viral resistance to non-nucleoside
reverse transcriptase inhibitor drugs in women given intrapartum nevirapine for perinatal HIV
prevention: an open-label randomised trial
Chi BH, Sinkala M, Mbewe F, et al
Lancet, 2007; 370(9600): 1668-70
Intrapartum and neonatal single-dose nevirapine are essential components of perinatal HIV
prevention in resource-constrained settings, but can induce resistance to other non-nucleoside
reverse transcriptase inhibitor drugs. The researchers aimed to investigate whether this
complication would be reduced with a single peripartum intervention of tenofovir and
emtricitabine. Chi and colleagues conclude that a single dose of tenofovir and emtricitabine at
delivery reduced resistance to non-nucleoside reverse transcriptase inhibitors at 6 weeks after
delivery by half; therefore this treatment should be considered as an adjuvant to intrapartum
nevirapine.
Implementation of a conservative checklist-based protocol for oxytocin administration:
maternal and newborn outcomes
Clark S, Belfort M, Saade G, et al
Am J Obstet Gynecol, 2007; 197(5): 480.e1-5
The purpose of this study was to examine the effects of a conservative and specific checklist-
based protocol for oxytocin administration on maternal and newborn outcome. The protocol was
based on maternal and fetal response to oxytocin rather than infusion rate. The results of the study
reveal that implementation of a specific and conservative checklist-based protocol for oxytocin
infusion based on maternal and fetal response results in a significant reduction in maximum
infusion rates of oxytocin without lengthening labor or increasing operative intervention.
Cesarean delivery rate declined system-wide following implementation of this protocol. Newborn
outcome also appears to be improved.
ACOG Practice Bulletin No.87 November 2007: Use of psychiatric medications during
pregnancy and lactation
American College of Obstetricians and Gynecologists
Obstet Gynecol, 2007; 110(5): 1179-98
No abstract is available.
Antithrombotic therapy and pregnancy: consensus report and recommendations for prevention
and treatment of venous thromboembolism and adverse pregnancy outcomes
Duhl AJ, Paidas MJ, Ural SH, et al
Am J Obstet Gynecol, 2007; 197(5): 457.e1-21
Venous thromboembolism and adverse pregnancy outcomes are potential complications of
pregnancy. This consensus group was convened to provide concise recommendations, based on
the currently available literature, regarding the use of antithrombotic therapy in pregnant patients
at risk for venous thromboembolic events and adverse pregnancy outcomes.
Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a
randomized controlled trial
Nassar AH, Usta IM
Obstet Gynecol, 2007; 110(5): 1170-1; author reply 1171
No abstract is available.
Inhaled nitric oxide for preterm infants: a systematic review
Barrington KJ, Finer NN
Pediatrics, 2007; 120(5): 1088-99
The objective of this study was to determine whether, for preterm newborn infants with
respiratory disease, inhaled nitric oxide reduced the rates of death, bronchopulmonary dysplasia,
intracranial hemorrhage or neurodevelopmental disability. The authors searched Medline,
EmBase, Healthstar, and the Cochrane Central Register of Controlled Trials as well as the
abstracts of the Pediatric Academic Societies. Results revealed that inhaled nitric oxide as rescue
therapy for very ill preterm infants undergoing ventilation does not seem to be effective and may
increase severe intracranial hemorrhage. Later use of inhaled nitric oxide to prevent
bronchopulmonary dysplasia does not appear to be effective. Early routine use of inhaled nitric
oxide for mildly sick, preterm infants seem to decrease the risk of serious brain injury and may
improve rates of survival without bronchopulmary dysplasia.
Neonatal hyperparathyroidism and pamidronate therapy in an extremely premature infant
Fox L, Sadowsky J, Pringle KP, et al
Pediatrics, 2007; 120(5): e1350-4
In their study, Fox and colleagues describe the use of pamidronate to control marked
hypercalcemia in an extremely premature infant with neonatal hyperparathyroidism that resulted
from an inactivating mutation (R220W) of the calcium-sensing receptor. Despite improvement in
bone mineralization and subsequent parathyroidectomy with normalization of the serum calcium
level, the combination of chronic lung disease, osteomalacia, and poor thoracic cage growth
ultimately proved fatal. The authors conclude that pamidronate therapy appears to be safe in the
short-term and effective in helping control hypercalcemia even in the very premature infant,
allowing for planned surgical intervention when it becomes feasible.
Protease inhibitor treatment of HIV-1 infected women may protect against extreme prematurity
and very low birth weight
Beckerman KP
J Infect Dis, 2007; 196(8): 1270-1; author reply 1271
No abstract is available.
Epilepsy in pregnancy
Tomson T, Hiilesmaa V
BMJ, 2007; 335(7623): 769-73
No abstract is available.
Pharmacokinetics of sulfadoxine-pyrimethamine in HIV-infected and uninfected pregnant
women in Western Kenya.
Green MD, van Eijk AM, van Ter Kuile FO, et al
J Infect Dis, 2007; 196(9): 1403-8
While sulfadoxine-pyrimethamine (SP) is among the most commonly used antimalarial drugs
during pregnancy, the pharmacokinetics of SP are unknown in pregnant women. According to the
researchers, HIV-infected (HIV(+)) women require more frequent doses of intermittent
preventive therapy with SP than do HIV-uninfected (HIV(-)) women. Green and colleagues
investigated whether this reflects their impaired immunity or an HIV-associated alteration in the
disposition of SP. They conclude that pregnancy significantly modifies the disposition of SP,
whereas HIV status has little influence on pharmacokinetic parameters in pregnant women.

Does a maximum dose of oxytocin affect risk for uterine rupture in candidates for vaginal
birth after cesarean delivery?
Cahill AG, Stamilio DM, Odibo AO, et al
Am Obstet Gynecol, 2007; 197(5): 495.e1-5
The objective of this study was to determine whether the maximum dose of oxytocin impacts the
risk of uterine rupture in women who attempt vaginal birth after cesarean delivery (VBAC).
Results showed that in VBAC attempts, a dose-response relationship of maximum oxytocin and
uterine rupture exists. These results provide evidence for vigilance when higher doses of oxytocin
are given to patients who attempt VBAC.
Long-term effects of caffeine therapy for apnea of prematurity
Schmidt B, Roberts RS, Davis P, et al
N Engl J Med, 2007; 357(19): 1893-902
Methylxanthine therapy is commonly used to for apnea of prematurity but in the absence of
adequate data on its efficacy and safety. This study examines the long-term effects of
methylxanthines on neurodevelopment and growth. Schmidt and colleagues randomly assigned
2006 infants with birth weights of 500 to 1250 g to receive either caffeine or placebo until
therapy for apnea of prematurity was no longer needed. The primary outcome was a composite of
death, cerebral palsy, cognitive delay (defined as a Mental Development Index score of <85 on
the Bayley Scales of Infant Development), deafness, or blindness at a corrected age of 18 to 21
months. In conclusion, caffeine therapy for apnea of prematurity improves the rate of survival
without neurodevelopmental disability at 18 to 21 months in infants with very low birth weight.
The use of olanzapine in pregnancy and congenital cardiac and musculoskeletal abnormalities
Yeshayahu Y
Am J Psychiatry, 2007; 110(1): 61-7
No abstract is available.
Lamotrigine in pregnancy. Clearance, therapeutic drug monitoring, and seizure frequency
Pennell PB, Peng L, Newport DJ, et al
Neurology, 2007; Nov 28 [Epub ahead of print]
The objective of this study was to characterize the magnitude and course of alterations in total
and free lamotrigine (LTG) clearance (Cl) during pregnancy and the postpartum period, to assess
the impact of therapeutic drug monitoring (TDM) on seizure frequency, to determine the ratio to
individual target LTG concentration that is associated with increased seizure risk, and to evaluate
maternal postpartum toxicity. The researchers analyzed 305 samples in 53 pregnancies. The
study found that although 39 percent of women reported an increase in seizure activity during
their pregnancy, 33 percent actually reported a decrease in seizures and 28 percent no change.
The health of the babies born was similar to that found in women who do not have epilepsy.

LAY PRESS NEWS

Canadian experts recommend boost in folic acid
CTV.ca, 2007; December 13

As many as half of certain birth defects could be prevented if women of childbearing age
consumed more folic acid, says a panel of experts as they release new guidelines about the
vitamin. It's long been known that folic acid supplements can help prevent neural tube defects,
such as spina bifida. All Canadian women of child-bearing age have been advised to take a
multivitamin containing 0.4 mg of folic acid every day. But now the experts from the Society of
Obstetricians and Gynaecologists of Canada and the Motherisk program at Toronto's Hospital for
Sick Children are calling on women to step up those levels. They say women planning pregnancy
should take a multivitamin containing between 0.4 and 1.0 milligram of folic acid at least two to
three months before conception, throughout pregnancy and keep taking it as long as breastfeeding
continues. Women who are smokers, obese, diabetic or with a previous history of spina bifida in
the family should be taking a multivitamin containing 5.0 milligrams of folic acid, three months
prior to and up to 12 weeks following conception. The panel of experts says new research
suggests that folic acid can do more than cut the risk of neural birth defects; it can also reduce the
rates of other birth defects such as congenital heart disease and some early pediatric cancers.
Novartis’ Myfortic poses fetal risks - FDA
Baertlein L, Hill G
Reuters.com, 2007; November 27

The FDA announced that Novartis AG’s organ rejection drug Myfortic increases the risk of first-
trimester miscarriage and birth defects. Data collected from the United States National
Transplantation Pregnancy Registry and postmarketing data collected from women who took the
drug during pregnancy revealed increased miscarriage risk, malformations of the external ear and
the face (such as cleft lip and palate), and anomalies of distal limbs (which include fingers and
toes), heart, esophagus and kidney. Novartis said the drug will carry a new safety warning which
will describe the risks. The FDA recommends that women who are planning a pregnancy should
not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs.
Female patients who are taking Myfortic must receive contraceptive counseling and must use
effective contraception.
28 women miscarry after receiving HPV vaccine Gardasil; FDA says no reason to re-examine
approval
FOXnews.com, 2007; December 6
The FDA has announced that the cervical cancer vaccine Gardasil is safe even though 28 U.S.
women who received the vaccine had miscarriages. According to the FDA, clinical trials show
that the vaccine’s miscarriage rate is consistent with that of the general population who were
given placebos and most of the miscarriages reported cannot be directly linked to Gardasil. The
FDA and the U.S. Centers for Disease Control and Prevention have concluded most side effects
are minor and there is no reason to re-examine the drug’s approval.
American College of Gastroenterology Offers Updated Clinical Guidance for Managing
Pregnant Patients
PR Newswire (U.S.), 2007; December 7
Physician experts from the American College of Gastroenterology have released a seven chapter
monograph entitled “Pregnancy in Gastrointestinal Disorders”, which provides up-to-date
clinical recommendations on managing common gastrointestinal disorders and challenges during
pregnancy. An important focus of the monograph addresses the challenges encountered in the
treatment and management of chronic digestive disorders in pregnancy. It includes a discussion of
pharmacologic and alternative therapies available to treat GI symptoms in pregnancy and,
importantly, identifies which medications are safe for use in pregnant women and those which
should be avoided. "The major risk to the fetus is encountered during the first trimester of
pregnancy," says Dr. Foxx-Orenstein. "It is important for physicians and expectant mothers to
maintain a high level of concern for the use of prescription and over-the-counter drugs to treat GI
symptoms during pregnancy."

Health Canada News Release: One year after launch, Canada’s Chemicals Management Plan
is on track and delivering results
www.hc-sc.gc.ca, 2007; November 20
The Government of Canada today announced a $3.9 million investment in Canada’s largest study
of the environmental chemicals in pregnant women and their babies. The study is being funded by
Health Canada, the Canadian Institutes of Health Research and the Ontario Ministry of the
Environment, which is contributing an additional $200,000. The study, known as the Maternal-
Infant Research on Environmental Chemicals (MIREC), is recruiting about 2,000 women during
the first trimester of pregnancy and following them through the birth of their child and up to eight
weeks after birth. MIREC is a collaborative effort among Health Canada scientists, the Sainte-
Justine Hospital in Montreal, and clinical researchers from Vancouver, Calgary, Winnipeg,
Sudbury, Ottawa, Kingston, Hamilton, Toronto and Halifax.

Thalidomide resurfaces as treatment for multiple myeloma: drug derivative may prolong life of
people battling incurable type of bone marrow cancer
CBC.ca, 2007; November 23
A study published in the New England Journal of Medicine has found that a derivative of
thalidomide may prolong life in people with a type of bone marrow cancer called multiple
myeloma - if taken with a steroid. Lenalidomide, in combination with the steroid dexamethasone,
can slow the progress of incurable bone marrow cancer and extend the lives of patients with the
condition by an average of 10 months. The research was funded by Celgene, the manufacturer of
thalidomide, which this week announced a $2.9-billion buyout of Pharmion, a biopharmaceutical
manufacturer that has been working with Celgene in marketing thalidomide as a cancer treatment.
Between 1957 and 1962, thalidomide was prescribed to treat morning sickness in pregnant
women. Worldwide, 10,000 people were born with missing or shrunken limbs, and came to be
known as "thalidomide babies." In Canada alone, it's estimated that about 100 babies were born
with severe deformities after their mothers took the drug during their pregnancies. The drug was
pulled from Canadian pharmacies in 1962. In the case of multiple myeloma, lenalidomide is
welcome news. Midway through the study, the clinical trial was halted to allow those participants
on placebos to be administered the drug. Dr. Darrell White, a hematologist with the Queen
Elizabeth II Health Sciences Centre in Halifax and one of the Canadian investigators in the study,
told CBC News that multiple myeloma patients typically have relapses as their treatments
become ineffective over time. "So for these patients with this incurable malignancy, this means
they have another effective treatment that they can move onto," he said. While the U.S. FDA
approved lenalidomide and dexamethasone in 2006, the drug is not yet approved for use in
Canada. Health Canada is currently reviewing an application from the manufacturer. If it is
approved, it will cost thousands of dollars a month and will be tightly controlled due to serious
and potentially toxic side effects.
In Depth Health: Thalidomide
CBC.ca, 2007; November 22
On their website, the CBC examines the drug Thalidomide. The history of Thalidomide’s use in
Canada, the deformities it caused in babies and the new indications for the drug are discussed.

FDA Official says legislation could foster lactation studies
FDA Week, 2007; December 7
An FDA official says legislation that allows the FDA to require drug makers to study mothers
who nurse as part of the drug approval process would foster more lactation research. Currently,
there is little scientific information on the extent to which drugs seep into breast milk or whether
they affect infants. Karen Feibus, medical team leader at FDA's Maternal Health Team, says the
FDA has no mechanism to force companies to submit lactation clinical trial data as part of new
drug or supplemental applications. Companies are often reluctant to do the studies because of
ethical concerns and potential lawsuits in the event children are hurt during clinical research.
"It would be wonderful" to have legislation, she says. "This sort of data would help practitioners
make good risk/benefit decisions for their patients." Recently passed FDA legislation may give
the agency expanded powers to request lactation studies if a serious drug safety signal arises, but
the signal would have to be well-defined. Feibus spoke at a Pediatric Advisory Committee
meeting last week that discussed issues surrounding the enrollment of lactating mothers and their
infants in clinical trials. The agency is proposing revisions to its 2005 draft guidance on clinical
lactation studies. The FDA asked the panel about the use of data from clinical lactation studies,
the timing of study enrollment for mother/infant pairs, labeling, and ethical issues related to
studying breastfeeding mother/infant pairs. The FDA expects to issue final lactation guidance by
the middle of next year.

FDA slightly eases access to birth defect-causing acne drug
Associated Press Newswires, 2007; December 5
The FDA announced that they have now implemented the changes to the iPledge program which
will ease access to Accutane, the acne medication which can cause severe birth defects. Women
of childbearing age who don't fill a prescription within seven days of a pregnancy test will be
allowed to get another test and then fill the prescription - with the exception of the initial
prescription. Until now, women who didn't act within seven days were frozen out of the program
for the next 23 days. These women will have to fill the prescription within seven days of a
pregnancy test rather than within seven days of first seeing their doctor.
Anti-depressants make babies smaller
AAP Bulletins, 2007; December 1
Melbourne researchers tracked 34 women taking antidepressant medication during their
pregnancy and the same number of women who did not. The babies born to women on
antidepressants are smaller and more likely to suffer tremor and irritability, but the symptoms
were not long lasting. According to lead researcher Dr. Megan Galbally, the symptoms were
minor and were gone within a month. They did not find any major complications such a
deformations and the level of symptoms seemed to correlate to the amount of medication taken
by the mothers. Dr. Galbally believes that antidepressant medication should be prescribed to
pregnant women on a case-by-case basis and women should discuss this issue with their doctors.
Questions pile up on birth drug trial
The Sydney Morning Herald, 2007; November 20
As part of a drug trial at Wagga Wagg Base Hospital in NSW, a number of women were
administered the drug misoprostol (marketed as Cytotec) to induce labour - regardless of the
safety warning against its use in pregnant women. One woman has settled a claim over a child
born with cerebral palsy and others may now sue. Cytotec is known to cause strong uterine
contractions which, if used in pregnant women, can cause catastrophic results. The case raises
many questions, but with the hospital and the relevant area health service ducking for cover, there
are as yet no answers.

Source: http://www.pregmedic.org/files/newsletter/CaseMed_2007_12_en.pdf