The Safety of Sumatriptan and Naratriptan in Pregnancy: What Have We Learned?

Cunnington, Marianne; Ephross, Sara A.; Churchill, Paige

doi:10.1111/j.1526-4610.2009.01529.x

Cited by 51 publications

(38 citation statements)

References 19 publications

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“…2010 had one study of fluoxetine (71), one of metformin (72), and one of glucose kinetics (73). In 2009, studies addressed dydrogesterone to prevent miscarriage in patients with second trimester vaginal bleeding (74), doxylamine/pyridoxine for nausea/vomiting of pregnancy (75), sumatriptan/naratriptan (76), safety of serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) (77), glyburide for gestational diabetes (78), lamotrigine for epilepsy (79), and clonidine (80). The drugs studied in 2008 were sertraline (81), enoxaparin (82), glyburide (83), aspirin in patients whose pregnancy was achieved via IVF (84), and finally midazolam and digoxin (as probe substrates studying CYP3A enzymes and P-glycoprotein) (85).…”

Section: Resultsmentioning

confidence: 99%

Obstetric Pharmacokinetic Dosing Studies are Urgently Needed

McCormack

Best

2014

Front. Pediatr.

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Use of pharmacotherapy during pregnancy is common and increasing. Physiologic changes during pregnancy may significantly alter the overall systemic drug exposure, necessitating dose changes. A search of PubMed for pharmacokinetic clinical trials showed 494 publications during pregnancy out of 35,921 total pharmacokinetic published studies (1.29%), from the late 1960s through August 31, 2013. Closer examination of pharmacokinetic studies in pregnant women published since 2008 (81 studies) revealed that about a third of the trials were for treatment of acute labor and delivery issues, a third included studies of infectious disease treatment during pregnancy, and the remaining third were for varied ante-partum indications. Approximately, two-thirds of these recent studies were primarily funded by government agencies worldwide, one-quarter were supported by private non-profit foundations or combinations of government and private funding, and slightly <10% were supported by pharmaceutical industry. As highlighted in this review, vast gaps exist in pharmacology information and evidence for appropriate dosing of medications in pregnant women. This lack of knowledge and understanding of drug disposition throughout pregnancy place both the mother and the fetus at risk for avoidable therapeutic misadventures – suboptimal efficacy or excess toxicity – with medication use in pregnancy. Increased efforts to perform and support obstetric dosing and pharmacokinetic studies are greatly needed.

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Section: Resultsmentioning

confidence: 99%

Obstetric Pharmacokinetic Dosing Studies are Urgently Needed

McCormack

Best

2014

Front. Pediatr.

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“…23,24 Registry data were also assessed for unusual patterns of defects or trends in birth defect frequency by dose. This paper summarizes the final results of the registry, which closed to enrollment in 2012 after over 16 years (1 January 1996-19 September 2012), updates previously published reports involving fewer pregnancy exposures, 21,22 and provides a summary of the published literature regarding migraine medication use in pregnancy.…”

Section: Introductionmentioning

confidence: 88%

“…7,21,22 However, initial post-marketing surveillance efforts began upon FDA approval of Imitrex in 1992, in response to a request by the FDA for further evaluation of the safety of sumatriptan in pregnancy. In 1993, GlaxoSmithKline (formerly Glaxo) initiated a large post-marketing surveillance study with over 10,000 sites.…”

Section: Introductionmentioning

confidence: 99%

Final Results From the 16‐Year Sumatriptan, Naratriptan, and Treximet Pregnancy Registry

Ephross

Sinclair

2014

Headache

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The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan. This finding is consistent with results from other observational studies using a variety of control groups. Enrollment in the registry was insufficient to permit definitive conclusions of the risks associated with naratriptan or sumatriptan/naproxen sodium tablets, or to assess the risk of individual birth defects in any of the products studied. Low enrollment and high rates of loss to follow up within the registry over an extended period of time led the registry's scientific advisory committee to conclude that continuation of the registry beyond its 16 years would offer little additional power to rule out more moderate increases in the risk of birth defects. Data from the other ongoing surveillance sources constitute an important element of post-marketing surveillance of these medications. The lack of a signal of major teratogenicity with sumatriptan across these several sources of data is encouraging.

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“…These data were obtained from the Sumatriptan and Naratriptan in Pregnancy Registry and may be subject to reporting bias. The authors conclude that the results coupled with lack of epidemiological evidence to support a strong association are reassuring since the reported rates compare favorably with the 3-6% background rate at 5 years of age [49,52 ]. Furthermore a thorough review of triptan use in pregnancy found that the available literature does not support different perinatal or pregnancy outcomes for patients exposed to triptans after conception [51].…”

Section: Antidepressants Amitriptylinementioning

confidence: 76%