Yourlawyer.com (Cleft Palates News)

Smoking During Pregnancy Ups Birth Defect Risks, May Lead to Fussy Babies

Wed, 05 Nov 2008 00:00:00 -0800

A mother's cigarette smoking during pregnancy not only increases the chances that her infant will be born with a cleft lip or palate, but can also have an effect on a baby's behavior, according to two new studies published in "The Journal of Pediatrics". An accompanying editorial said that the studies' findings indicate that smoking has become a major pediatric health problem.

In the first study, researchers from the March of Dimes and institutes in Norway, Holland, and Texas studied serum samples collected between 2003 and 2005 from pregnant women enrolled in the California Expanded AFP (alpha fetoprotein) program. The researchers measured the levels of cotinine, a metabolite of nicotine, to determine whether the mothers smoked during pregnancy.

The study found that women who smoked during pregnancy were nearly 2.5 times more likely to have babies with oral clefts. Babies with cleft palate or lip require significant medical care–often four surgeries by age two–and may have speech, hearing, and feeding problems

In the second study, researchers at Brown University studied the effects of cigarette smoke exposure on infant behavior. The researchers studied 56 otherwise healthy infants and used questionnaires and cotinine measurements to determine cigarette smoke exposure.

The study found that 28 babies who had been exposed to cigarette smoke were more irritable and difficult to sooth than the 28 babies who were not exposed. The researchers said their study highlighted the importance of cessation programs for smoking mothers, as well as programs to help new mothers manage a baby who is difficult to soothe.

In an accompanying editorial, Dr. Cynthia Bearer of the University of Maryland and Matthew Stefanak of the Mahoning County District Board of Health in Ohio, wrote that smoking should now be considered a major pediatric health problem. Citing the fact that 90 percent of smokers start smoking by the age of 18, the editorial advocated prevention as the best solution, and stressed the need to stop smoking before it starts.

The editorial stated that the graphic portrayal of the damaging effects of tobacco use on health and physical attractiveness may be effective in deterring teens from smoking. Because parents who actively disapprove of smoking can help their children avoid the harmful effects of cigarette smoke exposure, the writers of the editorial encouraged parents to take an active role in smoking prevention.

Glaxo bipolar drug may be tied to defect

Fri, 29 Sep 2006 00:00:00 -0700

Federal health officials cautioned women Friday that use of a GlaxoSmithKline drug during the first three months of pregnancy shows possible links to birth defects.

Newly reported data suggest a connection between the drug Lamictal, used to treat bipolar disorder and epilepsy, and lip defects in infants, according to a safety alert posted on the Food and Drug Administration's Web site.

In a registry of 564 pregnant women who took the drug during the first trimester, five gave birth to babies with a cleft lip or cleft palate, which is a gap in the upper lip or roof of the mouth. The agency advises women taking Lamictal who are pregnant or thinking of becoming pregnant to speak with their doctor.

While FDA says more data are needed before verifying the connection, it notes that similar registries have not recorded such a high occurrence of the defect.

GlaxoSmithKline said it first learned of the registry's findings in December 2005 and immediately notified the FDA. In June this year the British drug maker sent a letter explaining the findings to doctors.

"What the North American registry found hasn't been replicated by other pregnancy registries," said Holly Russell, GlaxoSmithKline's director of product communications. "It's FDA's position as well as our own that without confirming data the important thing is to continue to monitor data from ongoing pregnancy registries and other sources."

GlaxoSmithKline's revenues for Lamictal in fiscal 2005 were $1.34 million.

The drug maker announced last week that FDA approved Lamictal for an additional prescribed use in epilepsy patients who suffer "grand mal" seizures. The drug was previously approved to treat four other types of epileptic seizures, as well as adults with bipolar I disorder.

Glaxo Bipolar Drug May Be Tied to Defects

Fri, 29 Sep 2006 00:00:00 -0700

First-Trimester Exposure to Lamictal May Cause Oral Cleft

Fri, 29 Sep 2006 00:00:00 -0700

The US Food and Drug Administration (FDA) has notified healthcare professionals regarding new preliminary information from the North American Antiepileptic Drug Pregnancy Registry (NAAED), advising that fetal exposure to the oral antiepileptic drug (AED) lamotrigine (Lamictal, GlaxoSmithKline) during the first trimester of pregnancy may be linked to an increased risk for cleft lip or palate in newborns.

Because more research is required to confirm this risk, women who are pregnant or thinking of becoming pregnant are urged not to start or discontinue lamotrigine therapy prior to physician consultation, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

Oral clefts reported in the NAAED registry were few (5 cases in 564 women: 2 with isolated cleft lip and 3 with isolated left palate); overall prevalence was 8.9 per 1000 live births.

According to the FDA, the cases were not part of a syndrome that included other birth defects, and other pregnancy registries of similar size have not replicated this observation. The prevalence of nonsyndromic oral cleft among infants of nonepileptic mothers not treated with lamotrigine in the United States, Australia, and Europe ranges from 0.5 to 2.16 per 1000 live births.

Also, a comparison of the risk associated with lamotrigine cannot be compared with that of other new AEDs because of the small number of registry-enrolled patients.

Pregnant women who have received or require continuing treatment with lamotrigine during pregnancy may be registered by contacting the NAAED Pregnancy Registry at 1-888-233-2334. Patients may also register in a manufacturer-sponsored registry, which is aimed at obtaining additional data regarding this potential association, by calling 1-800-336-2176.

The FDA notes that because of the risk for medication errors based on the name similarities between lamotrigine (Lamictal) and several other drugs with similar names (eg, Lamaism, lamivudine, Ludiomil, labetalol, and Lomotil), prescribers and pharmacists are advised to ensure that “Lamictal” is written clearly on the script, and patients are encouraged to check the appearance of their medication.

Lamotrigine is indicated as adjunctive therapy for partial seizures, generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in patients aged 2 years and older.

It is also indicated as maintenance therapy to delay the time to occurrence of mood episodes in patients with bipolar I disorder receiving standard acute therapy; and for conversion to monotherapy in adults with partial seizures currently receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED.

Lamotrigine-related adverse events may be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Cleft Palate Birth Defect Injury Lawyer

Fri, 29 Sep 2006 00:00:00 -0700

Cleft Palates

A cleft palate is an opening in the roof of the mouth in which the two sides of the palate do not join together, as an unborn baby develops. A cleft palate can occur on one side (unilateral cleft palate), or on both sides (bilateral cleft palate). Cleft palates are one of the most common birth defects in the United States. Approximately, one in 600 newborns are born with cleft palates.

Cleft palates are congenital defects, or birth defects, that occur early in pregnancy. The majority of clefts tend to be due to a combination of genetics and environmental reasons. The risks of recurrence of a cleft condition is dependent upon numerous factors, including the number of affected persons in the family, the closeness of affected relatives, the race and sex of all affected persons, and the severity of the clefts.

The palate is made of bone and muscle and is enclosed by a thin, wet skin that forms the red covering inside the mouth. Its purpose is to split your nose from your mouth. The palate has a very symbolic role during speech, when you talk it prevents air from blowing out of your nose instead of your mouth. The palate is also very vital when eating. It prevents food and liquids from going up into the nose. During swallowing, the tongue presses up against the palate and pushes the chewed food to the back of the throat where it then goes down into the stomach.

Causes of Cleft Palates
Cleft palates can occur in conjunction with other syndromes or birth defects. There are numerous causes for these birth defects, including mutant genes inherited from one or both parents, drugs, viruses, and/or other toxins that may cause abnormalities in a developing fetus.

Symptoms of Cleft Palates

Separation of the palate
Nasal distortion
Ear infections
Inability to gain weight
Nasal regurgitations
Growth retardation
Misaligned teeth
Feeding problems
Poor speech

Legal Rights For Cleft Palate Defects
If you or a loved one has give birth and your child has been diagnosed with a cleft palate, please fill out the form to the right for a free case evaluation by a qualified birth defect attorney.