1. Contact:
Jim Ronca
Michael Monheit ReseaRCh and ReCent studies:
Clomid
Greg Spizer
Michael Schafle
Anita Pitock
Email:
jronca@anapolschwartz.com
Toll Free: (866) 735-2792
Contents
Read more information online at: What is Clomid? 2
www.anapolschwartz.com
Have there been any studies with Clomid and birth defects? 2
© 2011 All Rights Reserved. What are Clomid side effects? 2
Who should not take Clomid? 3
MEdiCAl diSClAiMER: This PdF
is not designed to and does not provide What are Clomid birth defect risks? 4
medical advice, professional diagnosis, References 5
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2. While fertility drugs can assist in the miracle of birth, they also have side effects for the patient and potential
birth defect risks for the baby. Here are some questions and answers to consider.
What is Clomid? data was used from the National Birth defects Prevention
Study, a population-based, multi-site case-control study of
Clomid is an orally administered non-steroidal fertility treat- major birth defects. Women from ten uS regions with deliver-
ment used to induce ovulation in women who have difficulty ies affected by at least one of >30 birth defects (cases) and
conceiving. Clomid is the brand made by Sanofi Aventis. Syn- mothers of live born infants without a major birth defect (con-
onyms include clomifene and clomiphene citrate. Serophene is trols) who delivered october 1997–december 2005 were inter-
another brand name. viewed. The exposure of interest was reported in clomiphene
citrate use in the period from two months before conception
through the first month of pregnancy. Women who conceived
What is the phaRmaCodynamiCs using assisted reproductive technology were excluded. Thirty-
of Clomid? six birth defect categories with at least three exposed cases
were studied.
Clomid is an orally administered, non steroidal, ovulatory stim-
ulant that acts as a selective estrogen receptor modulator. its in conclusion, several associations between clomiphene citrate
usage can lead to multiple ovulations and increases the risk use and birth defects were observed. However, because of the
of multiple births. There may be an increased risk of ovarian small number of cases, inconsistency of some findings with pre-
cancer and weight gain. vious reports, associations should be interpreted cautiously.
have theRe been any studies With What aRe Clomid side effeCts?
Clomid and biRth defeCts?
Enlarged ovaries, hot flashes, and abdominal or pelvic pain
are some of the most common side effects seen with Clomid.
There was a Center for disease Control and Prevention study
Side effects that are less common and occur in less than 1% of
for the use of clomiphene citrate and birth defects called the
patients may include constipation, diarrhea, and fatigue. Al-
National Birth defects Prevention Study, 1997–2005. Clomi-
though most Clomid side effects are considered minor, certain
phene citrate (CC) is the first line drug for subfertility treat-
side effects should be reported to your healthcare provider im-
ment. Studies assessing the association between CC and birth
mediately, including signs of an allergic reaction, changes in
defects have been inconclusive.
vision, or severe abdominal pain.
RESEARCH ANd RECENT STudiES: CloMid
Copyright © 2004–2011 All rights reserved. Anapol Schwartz.
Read more information online at www.anapolschwartz.com.
2

3. Who should not take Clomid? in What pRegnanCy dRug
CategoRy is Clomid?
you should not take Clomid if you have:
• Thyroid or adrenal problems Clomid is in Category X which means studies in animals or hu-
• A brain tumor mans have demonstrated fetal abnormalities and/or there is
positive evidence of human fetal risk based on adverse reac-
• ovarian cysts
tion data from investigational or marketing experience, and the
• Polycystic ovarian syndrome (PCoS) risks involved in use of the drug in pregnant women clearly
• Fibroids outweigh potential benefits.
• depression
• liver disease, including liver failure if Clomid is so Risky, hoW do
• Abnormal menstrual bleeding or abnormal periods Women tRying to get pRegnant
• Allergies to foods, dyes, or preservatives
not take Clomid While they aRe
or if you are: pRegnant?
• pregnant or may be pregnant
To avoid inadvertent Clomid administration during early preg-
• breastfeeding
nancy, appropriate tests should be utilized during each treat-
lastly, don’t forget to tell your doctor about all the medicines ment cycle to determine whether ovulation occurs. Women
you may be taking, including prescription drugs, vitamins, over- should be evaluated carefully to exclude pregnancy, ovarian
the-counter medications, and dietary and herbal supplements. enlargement, or ovarian cyst formation between each treat-
ment cycle. The next course of Clomid therapy should be de-
layed until these conditions have been excluded.
RESEARCH ANd RECENT STudiES: CloMid
Copyright © 2004–2011 All rights reserved. Anapol Schwartz.
Read more information online at www.anapolschwartz.com.
3

4. What aRe Clomid biRth The appearance of Clomid on this list does not mean that the
FdA has concluded that the drug has the listed risk. it means
defeCt Risks? that FdA has identified a potential safety issue, but does
not mean that FdA has identified a causal relationship between
if Clomid is taken during pregnancy, the risks of the following
the drug and the listed risk. if after further evaluation the FdA
birth defects increase:
determines that the drug is associated with the risk, it may take
• Congenital heart lesions a variety of actions including requiring changes to the labeling
• down’s syndrome of the drug, requiring development of a Risk Evaluation and
• Club foot Mitigation Strategy (REMS), or gathering additional data to
• Cleft lip and/or cleft palate better characterize the risk.
• undescended testes in males
• Blindness What aRe the visual pRoblems
• Spina bifida assoCiated With Clomid?
• Hernia
Blurring or other visual symptoms such as spots or flashes may
• Malformations
sometimes occur during the use of Clomid. These symptoms
• lifelong disability increase per incidence or duration and usually disappear within
• death a few days or weeks after Clomid is discontinued. These vi-
sual symptoms may make driving a car or operating machinery
more hazardous than usual.
have theRe been any Calls to
aCtion by the fda RegaRding
Clomid?
The Potential Signals of Serious Risks/New Safety information
identified from the Adverse Event Reporting System (AERS) be-
tween october and december 2008 notes the following:
CloMiPHENE CiTRATE (CloMid)
Visual Disorders
FdA is evaluating this issue to determine if the labeling,
which includes visual disorders in the Warnings and Adverse
Reactions sections, is adequate.
RESEARCH ANd RECENT STudiES: CloMid
Copyright © 2004–2011 All rights reserved. Anapol Schwartz.
Read more information online at www.anapolschwartz.com.
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5. should i file a laWsuit? RefeRenCes
it’s quite possible that you should and here’s why: your baby Pharmacodynamics
may require expensive procedures that health insurance will Reefhuis J, Honein MA, Schieve lA, Rasmussen SA; National Birth defects
most likely not cover or not cover in their entirety. There will be Prevention Study. use of clomiphene citrate and birth defects, National Birth
ongoing therapy, costly care giving, and numerous prescription defects Prevention Study, 1997–2005. Hum Reprod. 2011 Feb;26 (2):451–7.
drugs. if employed or self employed, you may need to take time Epub 2010; Nov 26. PubMed PMid: 21112952
off work. you, your family, and your baby’s pain and suffering Additional results: Clomiphene citrate use was reported by 1.4% of control
will be all consuming. A lawsuit can help pay for medical bills mothers (94/6500). Among 36 case-groups assessed, increased adjusted
odds ratios (aoR) were found [all: aoR, 95% confidence interval (Ci)] for
and expenses.
anencephaly (2.3, 1.1–4.7), dandy-Walker malformation (4.4, 1.7–11.6),
septal heart defects (1.6, 1.1–2.2), muscular ventricular septal defect (4.9,
When is the best time to file a birth defect lawsuit? 1.4–16.8), coarctation of aorta (1.8, 1.1–3.0), esophageal atresia (2.3, 1.3–
4.0), cloacal exstrophy (5.4, 1.6–19.3), craniosynostosis (1.9, 1.2–3.0) and
The sooner the better—it takes time to compile information
omphalocele (2.2, 1.1–4.5).
and hospital records. Every state has what is called statute of
drug information online
limitations and places limits on how long the injured party can
Potential Signals of Serious Risks/New Safety information identified from
wait to file a lawsuit. The last thing you want to do is lose that
the Adverse Event Reporting System (AERS) FdA—Guidance, Compliance,
opportunity to file. Regulatory information, Surveillance, Adverse drug Effects
Pregnancy eMed-TV
What is the statute of limitations to file a lawsuit?
Side effects, precautions, warnings
in Pennsylvania, New Jersey, and West Virginia, a personal in-
jury lawsuit must be filed within two years of the date when
the injury occurred.
How much does it cost to file a lawsuit?
Clients pay no out-of-pocket expense and only pay if and when
their settlement is received. A settlement affords you compen-
sation for mounting medical bills, caregivers, loss of income (if
still working), and pain and suffering.
Who is Anapol Schwartz?
Anapol Schwartz upholds traditions of excellence in medical
malpractice, pharmaceutical, toxic tort, class actions, products
liability, and automobile accident litigation. law offices are lo-
cated in Pennsylvania, New Jersey, West Virginia, Arizona, and
of Counsel in ohio.
RESEARCH ANd RECENT STudiES: CloMid
Copyright © 2004–2011 All rights reserved. Anapol Schwartz.
Read more information online at www.anapolschwartz.com.
5