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Pregnancy warning needed on hydroquinone-containing OTC products

14 Sep 2017

There appears to be a lack of pregnancy warning on hydroquinone-containing over-the-counter (OTC) dermatologic products, highlighting the need for improved labelling, according to a study.

Researchers obtained data from the Food and Drug Administration National Drug Code Directory and Label Repository and identified 112 OTC dermatologic products containing hydroquinone, an ingredient potentially harmful to foetus. Products were grouped into two, based on the presence or absence of pregnancy or general warning. Product characteristics including hydroquinone concentration, presence of external packaging, indication and warning statements were compared between the two groups.

Of the products studied, 21 had a pregnancy warning and three included a general warning against use. External packaging was more common in the warning-present group than in the warning-absent group (62.5 vs 29.5 percent; p=0.004).

Pregnant women deal with the challenge of choosing OTC drugs and personal care products (eg, cosmetics) that should not pose a safety threat to their foetus, researchers said. This underscores the importance of labelling OTC products for use by women of childbearing age, and the labels should communicate caution if a potentially harmful ingredient in the product should be either avoided or used in limited amounts during pregnancy.

There are a number of OTC products commonly used for conditions during pregnancy (eg, constipation, acne, dark spots and melasma), and these products may contain harmful ingredients that are potentially harmful to the foetus (eg, retinoids and hydroquinone). [J Am Acad Dermatol 2014;70:401; Coll Antropol 2008;32:139–141]

“Topical application of harmful ingredients may achieve percutaneous absorption into systemic circulation and reach foetal circulation. However, quantification of blood levels has not been performed for many topical agents to identify potential risk,” researchers noted.

Findings of the present study serve to increase awareness of OTC labelling limitations and call for action to protect pregnant women and their foetus, they added.

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Most Read Articles
Elaine Soliven, 27 Sep 2017
A second dose of kisspeptin-54 improves oocyte yield in women at high risk of ovarian hyperstimulation syndrome (OHSS) during in vitro fertilization (IVF) treatment, according to a recent study.
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Pearl Toh spoke with Dr Teh Ming Ming, senior consultant at the Department of Endocrinology, Singapore General Hospital (SGH), on the major challenges of diagnosing and managing diabetes in primary care, in conjunction with the World Diabetes Day on 14 November. Awareness of the symptoms of diabetes is important, and patients should be empowered to manage their conditions.
Rachel Soon, Yesterday

Pharmacists can and should utilize their positions within communities to provide access to an extended range of healthcare services, says an expert.

01 Aug 2017
New drug applications approved by US FDA as of 1 - 15 June 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.