Yourlawyer.com (Birth Defects 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.

Study Reveals Fertility Treatments Induce Gene Mutations in Males

Thu, 28 Aug 2008 00:00:00 -0700

Chinese researchers are reporting that the use of in vitro fertilization (IVF) or another assisted fertility technique called that is called intracytoplasmic sperm injection (ICSI) to conceive appears to increase the odds of Y-chromosome defects or "microdeletions" in male offspring. Although this study was small, it "at least sounds an alarm about the genetic safety of assisted reproductive technology," the investigators conclude.

This means that the chromosomal defects, or deletions, could result in defective sperm production and possibly also hypospadias. Hypospadia is a relatively common congenital malformation of the male sex organs in which the urinary outlet, or urethra, does not open through the glans of the penis, but rather, develops on the underside of the penis. This defect makes it difficult for the patient to urinate normally and to control one’s stream of urine. Generally, hypospadia occurs because of a hormonal imbalance or deficiency that takes place at a critical point in fetal development prior to birth. Early corrective surgery is generally called for before the child reaches the age of three.

Prior research has linked assisted reproductive technologies such as IVF and ICSI with low birth weight, pre-term delivery, cerebral palsy, and major birth defects. Because of this, some researchers believe that such therapies may prompt gene mutations. In this new study, Dr. He-Feng Huang, from Zhejiang University, and colleagues worked to find answers to this issue by testing for genetic mutations in 19 male infants who were conceived through IVF, 18 who were conceived through ICSI, and 60 baby boys were were conceived naturally. In addition, the fathers of the infant boys were also tested. Because the researchers were hoping to isolate the impact of the fertility treatment, they only studied those infants whose parents had a normal genetic background.

Huang and his colleagues found Y-chromosome microdeletions in one infant conceived with IVF, representing 5.3 percent of the population tested. Microdeletions were also found in three baby boys conceived with ICSI, which represented 16.7 percent of the population tested. By contrast, no Y-chromosome deletions were seen in the control group. The report also indicated that one of the four infants with microdeletions had hypospadias.

The investigators noted that this study is not the first to link ICSI with hypospadias; however, the mechanism has been unclear in the earlier studies. The new findings suggest that the association may be mediated through Y-chromosome microdeletions.

ICSI has long been the main method used to overcome male infertility and its use is on the rise. With ICSI, a single sperm is injected directly into a single egg. If successful fertilization occurs, the embryo is then placed into the female—in IVF treatment—to undergo development as usual. Fertilization rates—which are not the same as pregnancy rates—are relatively high when ICSI is employed with approximately 75%-80% of all eggs manipulated through ICSI becoming fertilized.

Larger studies "should be conducted to confirm our preliminary results," the researchers conclude.

Study finds more risks to unborn in epilepsy drug Depakote

Fri, 04 May 2007 00:00:00 -0700

One in four women who took the widely used epilepsy drug valproate while pregnant gave birth to children who were mentally retarded, double the rate among women who took other epilepsy medicines, researchers said .

The report, presented at the annual meeting of the American Academy of Neurology in Boston, was the latest to document the potential dangers of valproate to the unborn.

Last summer, researchers reported that 1 in 5 women who took the drug, sold as Depakote by Abbott Laboratories, had pregnancies that resulted in fetal death or birth defects, including malformed hearts and genitals, cleft palates and artery deformities.

Dr. Jacqueline French, a professor of neurology at the University of Pennsylvania, who was not involved in the study, said the latest findings were of great concern and that women of childbearing age should be informed of the risks, which are not included on the drug's warning label.

"It is time to have a different kind of conversation with our patients," French said.

An estimated 2.7 million Americans have epilepsy, a disorder in which clusters of nerve cells in the brain signal abnormally, causing seizures. Valproate has long been the preferred drug for treating generalized epilepsy, which affects up to one-half of patients.

The drug is also used to treat migraine headaches and some psychiatric conditions, including bipolar disorder. Abbott reported Depakote sales of $1.2 billion last year in the United States.

The latest study, led by Dr. Kimford J. Meador of the University of Florida in Gainesville, compared the IQs of 185 2-year-olds whose mothers had taken one of four epilepsy drugs while pregnant.

In addition to valproate, the drugs were carbamazepine, sold as Tegretol, lamotrigine (Lamictal) and phenytoin (Dilantin).

IQs were determined using the Bayley Scale for infant and toddler development. Researchers said a score of 100 was average and below 70 was mentally impaired.

Children whose mothers had taken valproate had an average IQ of 81, compared to an average of 96 for children in the carbamazepine group, 94 for the lamotrigine group and 95 for the phenytoin group.

Twenty-four percent of children whose mothers took valproate had IQs below 70, compared to 13% for carbamazepine, 11% for lamotrigine and 12% for phenytoin.

In the general population, an average of 2% of children have IQs below 70.

Meador said the research, funded by the National Institutes of Health, did not support a conclusion that all four drugs might cause mental retardation because the study was small and lacked a control group.

"The big thing is the difference between valproate and the other drugs," he said.

Abbott said in a statement that all epilepsy drugs posed serious risks, and Depakote's label made clear that the drug should not be a first-choice treatment for women of childbearing age.

Abbott said it was important to follow the progress of children in the study to see if they displayed cognitive impairments at age 6, when the study was scheduled to end.

The Food and Drug Administration had no comment on the study.

Women who must rely on valproate because they don't respond to other drugs should take the lowest possible dose if they become pregnant, Meador said. He stressed that pregnant women should not stop their epilepsy medication because a seizure could be dangerous for them and their fetuses.

French called for a mandatory informed consent process in which women of childbearing age would have to sign a document saying they were informed of the dangers before receiving prescriptions for valproate.

Epilepsy Drug Can Increase Risk for Newborns, Study Says

Fri, 04 May 2007 00:00:00 -0700

Doctors reported yesterday that expectant mothers with epilepsy who took a commonly prescribed drug to control seizures were at increased risk of having a child with mental deficits.

Toddlers who had been exposed in the womb to the drug Depakote, from Abbott Laboratories, scored seven to eight points lower on I.Q. tests at age 2 than those whose mothers had been taking other epilepsy drugs while pregnant, the study found. They were twice as likely to score in the range associated with mental retardation, according to the authors, who presented the findings at the annual meeting of the American Academy of Neurology in Boston.

Other researchers said the findings should be considered preliminary because I.Q. measures were less reliable in 2-year-olds than in older children; the study will continue, tracking children through age 6.

The report is consistent with several recent studies finding that Depakote is more likely than other so-called anticonvulsant drugs to increase the risk of mental deficits and other birth defects, like neural tube problems. An estimated 24 million American women have taken these drugs which include Tegretol from Novartis, Lamictal from GlaxoSmithKline and Dilantin from Parke Davis for an array of problems, including epilepsy, bipolar disorder and migraine headaches, according to an analysis by the Epilepsy Foundation.

“Depakote looks worse than the other drugs in all of these recent studies,” said Dr. Kimford J. Meador, a professor of neurology at the University of Florida and the lead author of the new study. “In all, it is compelling evidence that this drug should not be used as a first-line choice for treatment in pregnant women.”

Laureen Cassidy, a spokeswoman for Abbott, said that for many women, “Depakote may be the only effective seizure control medication, and that decision should be made thoughtfully between physician and patient to fully evaluate the risk vs. benefit of treatment.”

The drug’s label now states that Depakote “has been associated with birth defects in children of women who have taken it while pregnant.”

Untreated seizures can endanger the life of a fetus and the expectant mother. And some 90 percent of women with epilepsy give birth to healthy, developmentally normal children even though many are taking medication, experts say.

The researchers followed 185 children through age 2, using standard I.Q. measures. The mothers in the study, while pregnant, took either Depakote, Lamictal, Tegretol or Dilantin. After controlling for the mothers’ I.Q. scores, the researchers found that 2-year-olds exposed to Depakote scored significantly lower on standard intelligence measures than the others.

“It’s fair to say that there has been concern about these drugs, and particularly Depakote, for the past two or three years, but we’ll know the complete story about its effect on cognitive development when we look at older children,” said Dr. Lewis Holmes, a professor of pediatrics at Harvard Medical School.

DuPont Settles Birth Defect Lawsuits

Fri, 04 May 2007 00:00:00 -0700

The DuPont Co. has agreed to pay $9 million to settle two lawsuits alleging that the fungicide Benlate caused birth defects in children, according to court records and a federal regulatory filing.

In a Wednesday filing with the Securities and Exchange Commission, DuPont said it had reached a tentative settlement of lawsuits filed in 1997 on behalf of children in Britain and New Zealand born without eyes or with abnormally small eyes, defects also noted in the offspring of laboratory rats exposed to Benlate.

The plaintiffs alleged that the birth defects were the result of the children being exposed in the womb to Benlate.

According to DuPont, the settlement involves not only the six families named as plaintiffs in the lawsuits, but 26 other claimants.

The settlement comes after the Delaware Supreme Court last year upheld a lower court ruling granting DuPont summary judgment in a third lawsuit after rejecting opinions offered by two expert witnesses for the plaintiffs as inadmissible.

"If the settlement is approved by the court and finalized, it will resolve all birth defects claims known by DuPont to exist," the Wilmington-based chemical company said in its SEC filing.

DuPont spokeswoman Michelle Reardon said the company would not comment beyond the SEC filing. A Wilmington attorney representing DuPont in the litigation, did not immediately return a telephone call Friday.

In December, a Superior Court judge granted a request by attorneys in the case to stay the proceedings so that they could discuss a resolution short of going to trial. On April 5, Jacobs sent the judge a letter notifying him of the tentative settlement.

Also last month, six Hawaii plant nursery operators who claimed that contaminated Benlate damaged their crops settled their lawsuit against DuPont. That settlement was reached one day before a federal judge in Honolulu was set to start jury selection for a trial in which the growers were seeking as much as $30 million.

DuPont, which began manufacturing Benlate in the 1950s, decided to halt production in 2001 in the face of mounting crop damage claims. The company has paid more than $1 billion in settlements and legal fees on claims of damage from Benlate.

Glaxo Bipolar Drug May Be Tied to Defects

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.

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.

Glaxo bipolar drug may be tied to defect

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

Prescription Drugs Birth Defect Injury Lawyer

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

Birth Defects

Birth defects affect nearly one in every 33 babies born in the United States each year. Birth defects are the primary cause of infant deaths, accounting for more than 20%. Babies born with birth defects have a larger chance of illness and long-term disability than babies without birth defects. Birth defects occur while a baby is developing in the mother’s body. Birth defects can be discovered up to one year of birth, with the majority of birth defects detected within the first 3 months of pregnancy. The severity of birth defects can range from mild, where a surgery can correct the birth defect or to serious, leading to death.

Types of Birth Defects
Birth defects can affect almost any part of a baby’s body. Approximately 1 out of every 100 to 200 babies born each year are diagnosed with a heart defect. Brain and spine defects are other regular birth defects. These birth defects affect an estimated 1 of 1,000 pregnancies. Brain and spine birth defects are less frequent than heart defects, but they often cause many fetal and infant deaths. Birth defects of the lip and roof of the mouth are also common. These types of birth defects, are known as orofacial clefts, and consist of cleft lip, cleft palate, and combined cleft lip and cleft palate. Cleft lip is more common than cleft palate.

Hypospadias is a birth defect that is considered non-life threatening. Babies with hypospadias, the opening of the urethra (where urine comes out) is not at the tip of the penis but on the underside. Treatment depends on how far away from the tip the opening is and can involve complex surgery. This defect is rarely as serious, but it can cause great concern and sometimes has high medical costs. It seldom causes death.

What Causes Birth Defects
Close to 3% of babies born each year in the United States suffer from birth defects. Women over the age of 35 years have a greater chance of having a child with Down syndrome than women who are younger. Certain prescription drugs taking during pregnancy can increase the chance of birth defects. The following are some drugs that can cause birth defects: Accutane, Crestor, Cytotec, Lamictal, Lexapro, Paxil, Soriatane, and Terbutaline. Lastly some women have a higher chance of delivering a baby with a birth defect because someone in their family had a similar birth defect.

If you or a loved one has taken a prescription medicine and given birth to a child with a birth defect, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.