FDA-approved Medications during Pregnancy



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FDA-approved Medications during Pregnancy

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ulipristal acetate – FDA

www.accessdata.fda.gov

Administered Drugs. 7.3 Effects of ella on Co-Administered Drugs. 8 USE IN
SPECIFIC POPULATIONS. 8.1 Pregnancy. 8.3 Nursing Mothers. 8.4 Pediatric
Use. 8.5 Geriatric Use … If this drug is inadvertently used during pregnancy, the
woman should be apprised of the potential ….. [See FDA- Approved Patient
Labeling].

FDA Drug Safety Communication: FDA restricts use of prescription …

www.fda.gov

Apr 20, 2017 products are FDA-approved only for use in adults. We are also recommending
against the use of codeine and tramadol medicines in breastfeeding mothers due
to possible harm to their infants. As a result, we are requiring several changes to
the labels of all prescription medicines containing these drugs.

Advances in FDA's Safety Program for Marketed Drugs (PDF

www.fda.gov

Advances in FDA's. Safety Program for. Marketed Drugs. Establishing Premarket
Safety Review and Marketed Drug Safety as Equal Priorities at FDA's Center for
Drug Evaluation and Research …. national electronic system for monitoring the
safety of FDA-approved medical …. antipsychotic drugs taken during pregnancy).

Depression: Medicines To Help You rev. 9-09 – FDA

www.fda.gov

medicines for depression. The guide lists all of the FDA-approved products now
… Prozac (Fluoxetine) is the only FDA-approved medicine for children and teens
… Women should talk to their doctors about the risks of taking these drugs during
pregnancy. Common Side Effects. • Nausea. • Tremor (Shaking). • Nervousness.

Generic ER/LA Medication Guide – FDA

www.fda.gov

[Disclaimer: This template displays the important safety messages included in the
medication guides for each ER/LA opioid analgesic drug. … FDA approved
medication guides, including those for the ER/LA opioid analgesics, please visit
… Prolonged use of TRADENAME during pregnancy can cause withdrawal
symptoms …

Guidance – FDA

www.fda.gov

1 This guidance has been prepared by the Office of Drug Safety in the Center for
Drug Evaluation and Research. (CDER) … for the preparation and distribution of
manufacturer-prepared and FDA-approved patient labeling ….. Any risks to the
mother and the fetus or the infant from use of the drug during pregnancy, labor, or
 …

PROVIGIL® (modafinil) Tablets – FDA

www.fda.gov

Pregnancy Registry: There is a registry for women who become pregnant during
treatment with PROVIGIL. The purpose of this registry is to collect information
about the safety of PROVIGIL during pregnancy. Contact the registry as soon as
you learn that you are pregnant, or ask your doctor to contact the registry for you.

Cholesterol – Medicines To Help You rev. 8-09 – FDA

www.fda.gov

medicines. The guide lists all of the FDA-approved products now available to
treat this condition. You will also find some general information to help you use
your medicines wisely. … Sometimes cholesterol can build up in your heart and
cause chest pains. … Do not use these medicines if you are pregnant or nursing.

Coumadin (warfarin sodium) tablets Label – FDA

www.accessdata.fda.gov

Warnings and Precautions, Use in Pregnant Women with Mechanical. Heart
Valves (5.5). 10/2011 ….. COUMADIN is used during pregnancy or if the patient
becomes pregnant while taking this drug, the patient should be apprised of ……
See FDA-approved patient labeling (Medication Guide). Advise patients to: • Tell
their …

Content and Format of Labeling for Human Prescription Drug … – FDA

www.fda.gov

Populations” section of human prescription drug labeling. The Pregnancy and
Lactation. Labeling Rule (PLLR) will require that applicants with PLR labeling
comply with new content and format requirements. The “Pregnancy,” “Labor and
delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations”
 …

Prozac (fluoxetine hydrochloride) capsules label – FDA

www.accessdata.fda.gov

Consider tapering the dose of fluoxetine for pregnant women during the third
trimester (2.7). •. A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and for patients with concurrent disease or on
multiple concomitant medications (2.7). •. Dosing with PROZAC Weekly capsules
 …

Micardis (telmisartan) tablets – FDA

www.accessdata.fda.gov

When used in pregnancy, drugs that act directly on the renin-angiotensin system
can cause injury and even death to the developing fetus. When pregnancy is ……
See FDA-approved Patient Labeling. 17.1 Pregnancy. Inform female patients of
childbearing age about the consequences of exposure to drugs that act on the …

Mepolizumab – FDA

www.accessdata.fda.gov

6 ADVERSE REACTIONS. 6.1 Clinical Trials Experience. 6.2 Immunogenicity. 7
DRUG INTERACTIONS. 8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. 8.2
Lactation. 8.4 Pediatric Use. 8.5 Geriatric Use …… Advise the patient to read the
FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions.

Ambien Label – FDA

www.accessdata.fda.gov

NDA 19908 S027 FDA approved labeling 4.23.08 …. Pregnancy. 17.3.
Administration Instructions. 8.2. Labor and delivery. 17.4. Medication Guide. 8.3.
Nursing mothers. *Sections or subsections omitted from the full prescribing …
Ambien is contraindicated in patients with known hypersensitivity to zolpidem
tartrate or to any.

Label (PDF) – FDA

www.accessdata.fda.gov

6.2 Postmarketing Experience. 7 DRUG INTERACTIONS. 8 USE IN SPECIFIC
POPULATIONS. 8.1 Pregnancy. 8.2 Labor and Delivery. 8.3 Nursing Mothers. 8.4
Pediatric … 17.7 FDA-Approved Patient Labeling. *Sections or …. reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the
 …

BEVYXXA ™ (betrixaban) – FDA

www.accessdata.fda.gov

7. DRUG INTERACTIONS. 7.1 Inhibitors of P-gp. 7.2 Anticoagulants, Antiplatelets
, and Thrombolytics. 8. USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. 8.2
Lactation. 8.4 Pediatric Use …… PATIENT COUNSELING INFORMATION. Advise
the patient to read the FDA-approved patient labeling (Medication Guide). 18.

Singulair (montelukast sodium) tablet label – FDA

www.accessdata.fda.gov

FDA-approved patient labeling. Revised: 03/2012 … 6.2 Post-Marketing
Experience. 7 DRUG INTERACTIONS. 8 USE IN SPECIFIC POPULATIONS. 8.1
Pregnancy. 8.3 Nursing Mothers. 8.4 Pediatric Use … SINGULAIR® is indicated
for the prophylaxis and chronic treatment of asthma in adults and pediatric
patients 12 …

Label (PDF) – FDA

www.accessdata.fda.gov

Doxycycline like other tetracycline-class drugs, can cause fetal harm when
administered to a pregnant woman (5.1, 8.1). •. The use of drugs of the
tetracycline class during tooth development may cause permanent discoloration
of the teeth (5.1, 8.4). See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved.