Cleft lip is one of the most common birth defects, occurring in about one in 594 babies born every year in the United States, and in roughly half of these cases, babies with a cleft lip will also have a cleft palate. Unfortunately, babies born to women who take certain pharmaceutical drugs while pregnant may have a significantly increased risk of developing cleft lip and other serious congenital malformations. If your child was born with cleft lip and you believe a potentially dangerous pharmaceutical drug to be the cause, our consumer advocates at the Consumer Justice Foundation can help. We are committed to helping consumers who have been harmed by allegedly defective medications, and can help put you in touch with a qualified attorney who has experience handling birth defect claims.
Cleft lip is a craniofacial birth defect characterized by the malformation of a child’s upper lip that occurs while the baby is still in the womb. A baby’s face and skull develop during the first few months of pregnancy, and it is during this period that a child may be vulnerable to craniofacial birth defects like cleft lip. Clefting, such as the kind that is seen in cleft lip and another oral defect called cleft palate, occurs when there isn’t enough tissue in the mouth or lip area during fetal development, and the tissue that is available fails to join together properly.
A cleft lip is a split or separation of the two sides of a baby’s upper lip, which is easily diagnosed with a physical examination of the mouth and nose after birth, since the malformation creates such an obvious physical change. The cleft appears as a narrow opening or gap in the skin of the upper lip, and can range in severity from a small notch to a severe crevice in the child’s lip. In serious cases of cleft lip, the opening may even extend up into the nose, involving the bones of the upper jaw and/or the upper gum. Cleft lip can occur on one or both sides of the upper lip, and can occur with or without cleft palate.
The only way to permanently correct a cleft lip and repair the complications associated with the birth defect is for the child to undergo reconstructive surgery to close the separation in the upper lip. Because of the variety of medical problems and oral health issues that are associated with cleft lip, treating this birth defect typically requires a team of doctors and other specialists, including a plastic surgeon, speech pathologist, oral surgeon, orthodontist, dentist, audiologist, speech therapist, and others. A cleft lip may require multiple surgeries, depending on the extent of damage to the lip, and there are a number of lifelong complications associated with cleft lip birth defects, including:
One of the potential causes of a cleft lip birth defect is associated with any medications a mother may have taken during pregnancy. Some dangerous pharmaceutical drugs can interfere with the development of a fetus, particularly during the early stages of pregnancy, resulting in major birth defects like cleft lip. Among the medications that may cause cleft lip birth defects are certain anticonvulsant and antidepressant drugs, as well as some other prescription medicines, including the following:
July 2012 – Twenty-seven mothers file product liability lawsuits against Abbott Laboratories, alleging that Depakote use in pregnancy caused their children to be born with birth defects.
January 2014 – A product liability lawsuit brought against Abbott Laboratories in an Illinois court alleges that the drug manufacturer failed to provide adequate warnings about the alleged risk of birth defects from Depakote use in pregnancy.
March 2014 – A Pennsylvania jury awards $3 million to the family of a five-year-old boy born with a cleft lip birth defect after being exposed to Topamax during pregnancy.
April 2014 – Johnson & Johnson’s Janssen unit settles 76 Topamax birth defect lawsuits filed over congenital malformations allegedly caused by the anticonvulsant drug, including cleft lip and cleft palate.
July 2014 – Thirteen Zoloft lawsuits are brought against Pfizer on behalf of children who suffered birth defects after being exposed to the SSRI antidepressant in utero.
March 2015 – A judge upholds an $11 million jury award delivered in a Topamax lawsuit filed by the family of a boy born with a cleft lip birth defect, despite an appeal by Janssen Pharmaceuticals.
April 2015 – A couple from Montana files the first product liability lawsuit over cleft lip birth defects from Zofran, alleging that their daughter’s exposure to the anti-nausea drug in utero caused her to be born with a cleft lip and cleft palate.
May 2015 – An Arkansas couple files a Zofran lawsuit against GlaxoSmithKline, alleging that the company’s anti-nausea drug caused their son to be born with a cleft lip birth defect.
June 2015 – A Philadelphia jury recommends making changes to the Zoloft warning label to reflect the potential risk of birth defects associated with Zoloft use in pregnancy.
December 2005 – The FDA issues a public health advisory warning about the potential for Paxil use during pregnancy to cause serious birth defects in unborn babies.
July 2006 – The FDA adds a black box warning to the Depakote label highlighting the potential for babies exposed to the anticonvulsant drug in utero to develop serious birth defects.
December 2009 – A drug safety communication issued by the FDA warns that women who take Depakote while pregnant may have an increased risk of giving birth to babies with serious birth defects, including craniofacial malformations like cleft lip.
March 2011 – A warning issued by the FDA updates warnings on the Topamax label to include information about the potential for the anticonvulsant drug to cause certain types of birth defects, including cleft lip and cleft palate, when used by pregnant women.
January 2012 – The FDA lists Celexa, Paxil, Effexor, Prozac, Lexapro, Zoloft and Wellbutrin among its Top 10 medications that should not be taken by pregnant women.
Data from the North American Antiepileptic Drug Pregnancy Registry (NAAED) indicates that the rate of major birth defects (like craniofacial malformations) in babies born to epileptic women taking Depakote is nearly four times higher than the rate in babies born to epileptic women taking another anticonvulsant drug.
August 2006 – Approximately 20.3% of pregnant women who took Depakote suffered serious adverse outcomes related to the birth of their children, compared to only 1% to 10.7% of pregnant women who took similar medications, according to research published in the journal Neurology.
June 2007 – According to a study published in the New England Journal of Medicine, babies whose mothers take Zoloft while pregnant may be more likely to develop birth defects like cleft lip and cleft palate.
July 2009 – Women who take Depakote while pregnant may have a nearly three-times increased risk of giving birth to babies with major malformations, like craniofacial birth defects, according to research published in the journal Reproductive Toxicology.
July 2010 – Depakote and other valproate-based anticonvulsant medications are more than twice as likely to cause major congenital malformations when taken during pregnancy, compared to Tegretol and Lamictal, according to a report from the UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy.
November 2011 – A study funded by the U.S. Centers for Disease Control and Prevention (CDC) finds that women prescribed Zofran during the first 12 weeks of pregnancy are 2.37 times more likely to give birth to babies with oral cleft birth defects like cleft lip and cleft palate.
July 2012 – Research published in the American Journal of Obstetrics & Gynecology indicates that women who use Topamax during the first trimester of pregnancy may be more likely to give birth to babies with oral cleft birth defects, including cleft lip with or without cleft palate.
August 2012 – The American Headache Society finds an increased risk of oral clefts and other major birth defects among babies whose mothers take Topamax during pregnancy, compared to babies whose mothers take other anticonvulsant drugs during pregnancy.
December 2013 – The journal BioMed Research International publishes a study involving 96,968 births in Western Australia, indicating that expectant mothers who take Zofran during the first trimester of pregnancy have a 20% increased risk of giving birth to babies with major birth defects.
June 2014 – An article published by the Toronto Star highlights 20 incidents where babies exposed to Zofran in utero were born with mouth deformities and other congenital malformations.
Cleft lip is a serious birth defect, which could be caused by a child’s exposure to potentially dangerous pharmaceutical drugs during pregnancy. Unfortunately, like many other congenital malformations, cleft lip occurs during the early stages of pregnancy, before many women are even aware they are pregnant, and can have a significant impact on the affected child’s quality of life in the future. The families of children born with cleft lip birth defects after being exposed to certain medications in utero are pursuing legal claims against the drug manufacturing companies, accusing them of:
Babies born with cleft lip birth defects sometimes suffer long-term complications of the malformation, including chronic ear infections, difficulty speaking, hearing loss and significant dental problems. If you or a loved one has suffered a cleft lip birth defect, which you believe to be associated with a defective drug, contact a qualified birth defect attorney for legal help. You may have grounds to file a product liability lawsuit against the drug manufacturing company, in order to pursue the financial compensation you deserve for your injuries, medical expenses, and pain and suffering.