Yourlawyer.com (Lamictal Birth Defects News) http://www.yourlawyer.com/topics/overview/Lamictal-Lawsuit-Side-Effects-Birth-Defects-Cleft-Lip-Cleft-Palate Tue, 02 Sep 2014 00:16:17 -0400 Tue, 02 Sep 2014 00:16:17 -0400 pixel-app en Lamictal May Cause Meningitis, FDA Warns http://www.yourlawyer.com/articles/title/lamictal-may-cause-meningitis-fda-warns Thu, 12 Aug 2010 00:00:00 -0400 http://www.yourlawyer.com/articles/title/lamictal-may-cause-meningitis-fda-warns Lamictal (lamotrigine), a treatment for seizures and bipolar disorder marketed by GlaxoSmithKline, can cause aseptic meningitis, the US Food & Drug Administration (FDA) warned today. The agency said it is working with Glaxo to update the Warnings and Precautions section of the prescribing information and the patient medication guide for Lamictal to include this risk.

Meningitis is an inflammation of the protective membranes (the meninges) that cover the brain and spinal cord. Aseptic meningitis is generally diagnosed when tests of a patient with signs and symptoms of meningitis do not detect bacteria. Causes of aseptic meningitis include viruses and other non-bacterial infections, toxic agents, some vaccines, malignancy, and certain medications, including Lamictal.

Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly initiated. The FDA is advising any patient taking Lamictal to contact their healthcare provider if they experience any of these symptoms.

According to an FDA alert issued today, a review of adverse event reports submitted to the agency from December 1994 (when the drug was approved) through November 2009 revealed that 40 cases of aseptic meningitis were reported in pediatric and adult patients taking Lamictal. Thirty-five of the 40 patients required hospitalization. There was one reported death, although the death was not thought to be the result of aseptic meningitis.

In the 40 cases, headache, fever, nausea, vomiting, nuchal rigidity, rash, photophobia and myalgias were noted. According to the FDA, symptoms occurred 1 to 42 days after starting Lamictal (mean of 16 days). In the majority of cases, symptoms resolved after Lamictal was discontinued. Fifteen cases reported a rapid return of symptoms following re-initiation of Lamictal, with symptoms reoccurring within 30 minutes to 24 hours following re-initiation of Lamictal (mean of 5 hours). In these rechallenge cases, symptoms were frequently more severe after re-exposure, the FDA said.

According to the FDA, some of the patients treated with Lamictal who developed aseptic meningitis had underlying diagnoses of systemic lupus erythematosus or other autoimmune diseases. In addition, some patients also had new onset of signs and symptoms of involvement of other organs (predominantly hepatic and renal involvement), which may suggest that some of the cases of Lamictal-associated meningitis were part of a hypersensitivity or generalized drug reaction.

Healthcare professionals should be aware that Lamictal can cause aseptic meningitis, the FDA said. If meningitis is suspected, patients should also be evaluated for other causes of meningitis and treated as indicated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.

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Epilepsy Drugs to Carry Suicide Warnings http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-carry-suicide-warnings Wed, 17 Dec 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-carry-suicide-warnings Epilepsy drugs must now carry warnings about their suicide risks, the Food & Drug Administration (FDA) has announced.  The drugs subject to the new warning include those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.  Epilepsy drugs on the list are:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)

Any available generic versions of these drugs will also carry the new epilepsy drugs, the FDA said.

The FDA said its actions were based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo, the agency said.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The FDA added that the biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

In addition to the suicide warning, the FDA is also requiring the drugs' manufacturers to submit f a Risk Evaluation and Mitigation Strategy for each medication , including a Medication Guide for patients. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

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Epilepsy Drugs Targeted for Black Box Suicide Warning http://www.yourlawyer.com/articles/title/epilepsy-drugs-targeted-for-black-box-suicide-warning Tue, 08 Jul 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/title/epilepsy-drugs-targeted-for-black-box-suicide-warning epilepsy drugs to add a black box warning to their labels about their association with suicidal thoughts and behavior. The Food & Drug Administration (FDA) is set to ask an outside advisory panel for its recommendations on the proposed black box at a meeting this Thursday.   

In total, 11 epilepsy drugs could get the new black box warning - the FDA's strongest safety notice. They include:

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

According to the FDA, three of the 11 drugs studied showed no clear signal of suicidal problems.  However, the agency is still leaning towards including the warning on all the drugs, as sample sizes in some of the studies might have been too small to accurately assess suicide risks.  One of the issues the agency will ask the panel to address at Thursday's meeting is whether all of the drugs, or just some of them, should be subjected to the black box.

The FDA is not bound to follow the recommendations of its advisory panels, but it usually does so.

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New Suicide Warning for Epilepsy Drugs http://www.yourlawyer.com/articles/title/new-suicide-warning-for-epilepsy-drugs Thu, 12 Jun 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/title/new-suicide-warning-for-epilepsy-drugs epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior.  The analysis was released this week and confirmed earlier findings.  "The effect appears consistent among the group of 11 drugs" that were reviewed, according to a summary from statistical reviewers at the Food and Drug Administration (FDA).  In the review dated May 23, the FDA staff said that there were about two more cases of suicidal thoughts and behavior per every 1,000 patients given the drugs versus those given a placebo.  In January, the FDA released similar findings, according to FDA spokeswoman Sandy Walsh.

The epilepsy drugs include Pfizer Inc.'s Lyrica, GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax, and Abbott Laboratories Inc.'s Depakote.  FDA officials said that they are working with the drug makers to add information about the suicidal behavior risk to the prescribing instructions for these drugs.  Also, a panel of outside advisers to the FDA is scheduled to discuss the issue next month, on July 10.

The FDA staff reviewed 199 trials involving about 44,000 patients who were given either an epilepsy drug or a placebo.  Some of the epilepsy medicines are also approved for depression, migraines, and other conditions.  As a result, four patients given drug treatment committed suicide, compared with zero suicides in the group who received the placebo, according to the FDA staff review.  Generally, approximately 0.4 percent of drug-treated patients reported suicidal thoughts or actions, compared with 0.2 percent of placebo patients.  

In January, the FDA warned that all patients taking epilepsy drugs should be closely monitored for changes in behavior that could indicate either suicidal thoughts or behaviors or depression.  Kara Russell, spokeswoman at Johnson & Johnson's Ortho-McNeil Neurologics Inc. unit—the group that makes Topamax—said the company was reviewing the FDA's report and confirmed that language about possible suicide behaviors or attempts "has existed in our labeling since the beginning."  UCB SA spokeswoman, Andrea Levin, said prescribing instructions for its epilepsy drug, Keppra, already included data on suicidal behavior reported in clinical trials.  Levin advised that UCB SA would comply if the FDA asked for changes.

A Glaxo analysis of Lamictal found a trend for suicidal thoughts and behavior that was similar to that found in the FDA analysis, according to company spokeswoman, Holly Russell. Glaxo is currently working with regulators to update the drug label, she said.  Abbott spokeswoman Laureen Cassidy said the company would work with the FDA to implement any changes requested for the class of drugs.

Epilepsy is a neurological condition that, from time-to-time produces brief disturbances in normal electrical brain functions.  When someone has epilepsy, normal electrical brain patterning may be interrupted by intermittent bursts of electrical energy that are much more intense than usual.  These interruptions and bursts may affect a person's consciousness, bodily movements, or sensations for a short time and are called epileptic seizures and are why epilepsy is sometimes called a seizure disorder.  The bursts may occur as partial seizures affecting just one area of the brain or can be generalized, affecting nerve cells throughout the brain.

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Epilepsy Drugs to Get Suicide Warnings, FDA Confirms http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-get-suicide-warnings-fda-confirms Fri, 06 Jun 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-get-suicide-warnings-fda-confirms US regulators are very close to finalizing new suicide warnings for 11 epilepsy drugs, The Wall Street Journal reported today.  This past January, the Food & Drug Administration (FDA) issued an Early Communication announcing a safety review of the epilepsy drugs after a study showed they increased patients' risk of suicidal thoughts and behavior.

The 11 epilepsy drugs slated for a new suicide warning are:

In addition to treating epilepsy, the anti-seizure medications are used for a variety of other illnesses, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005.  In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades.   The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills. 

 According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers.  The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.  For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

In an interview with The Wall Street Journal, Russell Katz, director the FDA's neuropharmacological drug division confirmed the suicide warnings are coming.  "We are working on the labeling changes that we want to get to the companies," he said.  An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide on July 10, but the Journal speculated the new warnings could come even sooner than that.

At least one drug maker, Pfizer Inc., is less than pleased at this development.  Pfizer disputed the FDA's analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York.  Pfizer especially disputes the inclusion of Lyrica - one of the company's biggest growth drivers -on the FDA's warning list.  Pfizer said that Lyrica accounted for only 6.3% of the total 142 suicidal events cited by the FDA analysis.  But the FDA is sticking to its guns, and the new suicide warning will apply to all 11 epilepsy drugs.

Most other epilepsy drug makers are resigned to the label changes, according to the Journal.  GlaxoSmithKline, the maker of Lamictal, approached the FDA this year to volunteer changes regarding possible suicidal-behavior risks.  Other drug makers may have chosen not to challenge the FDA on suicide warnings because their medications are no longer as lucrative as they once were, as patents on many epilepsy drugs have, or are close to, expiring.

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Epilepsy Drugs Double Suicide Risks, FDA Warns http://www.yourlawyer.com/articles/title/epilepsy-drugs-double-suicide-risks-fda-warns Sat, 02 Feb 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/title/epilepsy-drugs-double-suicide-risks-fda-warns Epilepsy drugs have been linked to a increased risk of suicidal thoughts and behavior, the Food & Drug Administration (FDA) warned this week.  According  to an FDA analysis, people taking antiepileptic drugs are twice as likely to experience suicidal thoughts or behavior than those taking placebo.

The FDA began investigating if epilepsy drugs pose any suicide risk in 2005.  In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The  antiepileptic medications studied by the FDA  included:

•    Carbamazepine(marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
•    Felbamate (marketed as Felbatol)
•    Gabapentin (marketed as Neurontin)
•    Lamotrigine (marketed as Lamictal)
•    Levetiracetam (marketed as Keppra)
•    Oxcarbazepine (marketed as Trileptal)
•    Pregabalin (marketed as Lyrica)
•    Tiagabine (marketed as Gabitril)
•    Topiramate (marketed as Topamax)
•    Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
•    Zonisamide (marketed as Zonegran)

The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.  According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers.  The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. There was no clear pattern of risk across age groups.

Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.  According to the FDA for every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.  Even though the FDA only looked at 11 epilepsy medications, the agency said the suicide warning applied to all epilepsy drugs.

Millions of people  take epilepsy drugs. Such anti-seizure medications are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.
 

Doctors and other healthcare providers where advised by the FDA to balance the risk for suicidal thoughts and behavior with the clinical need for the drug  and to be  aware of the possibility of the emergence or worsening of depression, suicidality, or any unusual changes in behavior.  Healthcare providers where told to inform patients, their families, and caregivers of the potential for an increase in the risk of suicidality so they are aware and able to notify their healthcare provider of any unusual behavioral changes.

Because skipping epilepsy medication can result in seizures, the FDA said  that patients should ask a doctor before making medication changes.  The FDA said patients and their families should pay close attention to any day-to-day changes in mood, behavior and actions.  These changes can happen very quickly so it is important to be mindful of any sudden differences.  Patients and their families should be aware of common warning signs that might be a signal for risk of suicide, inlcuidng  talking or thinking about wanting to hurt themselves or end their lives; withdrawing from friends and family; Becoming depressed or having  depression get worse; becoming preoccupied with death and dying; and giving away prized possessions. If these or any new and worrisome behaviors occur, patients or their families should contact the responsible healthcare professional immediately.

The FDA said it would be working with manufacturers of marketed epilepsyc drugs to include this new information about suicide risks in the labeling for these products. The agency anticipates that labeling changes will be applied broadly to the entire class of drugs. The  FDA is also planning to discuss the suicide data at an upcoming advisory committee meeting.

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Glaxo bipolar drug may be tied to defect http://www.yourlawyer.com/articles/title/glaxo-bipolar-drug-may-be-tied-to-defect Fri, 29 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/glaxo-bipolar-drug-may-be-tied-to-defect 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.

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Glaxo Bipolar Drug May Be Tied to Defects http://www.yourlawyer.com/articles/title/glaxo-bipolar-drug-may-be-tied-to-defects Fri, 29 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/glaxo-bipolar-drug-may-be-tied-to-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.
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First-Trimester Exposure to Lamictal May Cause Oral Cleft http://www.yourlawyer.com/articles/title/first-trimester-exposure-to-lamictal-may-cause-oral-cleft Fri, 29 Sep 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/first-trimester-exposure-to-lamictal-may-cause-oral-cleft
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.]]>
Company notes association between anti-epileptic drug, cleft palate in babies http://www.yourlawyer.com/articles/title/company-notes-association-between-anti-epileptic-drug-cleft-palate-in-babies Wed, 09 Aug 2006 00:00:00 -0400 http://www.yourlawyer.com/articles/title/company-notes-association-between-anti-epileptic-drug-cleft-palate-in-babies
In the general population, oral clefts are among the most common major birth defects, occurring at rates of 0.5 to 2.16 per 1,000 births, according to GlaxoSmithKline. The pregnancy registry showed three cases of cleft palate and two cases of cleft lip in infants born to 564 users of the drug, a rate of 8.9 per 1,000.

Patients taking the drug should notify their doctors if they become pregnant or intend to become pregnant during therapy with Lamictal, the statement says.

"Although pregnant women and their unborn children may face significant health risks from uncontrolled epilepsy, Lamictal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."

But stopping or starting the drug should only be done after consulting with a doctor, the statement says.

"Sudden discontinuation of anti-eplieptic therapy may lead to breakthrough seizures with serious consequences for both the mother and the fetus and should be avoided."

Peter Schram, a spokesman for the drug company, said other discontinuation symptoms can include rashes, dizziness, headaches, nausea and blurred vision.

The drug has been marketed in Canada since 1995 for the treatment of epilepsy. It acts on sodium channels to stabilize the membrane of neurons in the brain and to prevent the excessive release of chemicals that carry electrical impulses between neurons, said GlaxoSmithKline.

Health Canada spokesman Chris Williams noted that some other anti-epileptic drugs on the market in Canada currently contain warnings about birth defects, and some don't.

"However, the product monographs of all anti-epileptic drugs carry the general statement that the drug should only be used in pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus," he said.

The company has sent its new safety information to health-care professionals.
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Lamictal Side Effects Lawsuits | Side Effects: Birth Defects, Cleft Lip, Cleft Palate http://www.yourlawyer.com/topics/overview/Lamictal-Lawsuit-Side-Effects-Birth-Defects-Cleft-Lip-Cleft-Palate Wed, 09 Aug 2006 00:00:00 -0400 http://www.yourlawyer.com/topics/overview/Lamictal-Lawsuit-Side-Effects-Birth-Defects-Cleft-Lip-Cleft-Palate Lamictal Lawsuit | Side Effects : Birth Defects, Cleft Lip, Cleft Palate

Lamictal Lawsuit | Lawsuits, Lawyer, Attorney | Side Effects: Birth Defects, Cleft Lip, Cleft Palate

Lamictal Birth Defects Reported to the FDA

In September 2011, AdverseEvents, Inc. reported that its analysis of the FDA's Adverse Event Reporting System (AERS) indicated that Lamictal was more dangerous to unborn babies than previously thought. The analysis indicated that moving Lamictal from its current FDA pregnancy risk class, Category C (“no known human risk”), to Category D (“positive evidence of human fetal risk") could be warranted.

In conducting its analysis, AdverseEvents used a proprietary process called RxFilter to analyze the FDA’s AERS database for treatment-related birth defects, stillbirths and congenital abnormalities potentially associated with 18 anti-epilepsy medications, including Lamictal, that are commonly prescribed during pregnancy. The time period covered by the AdverseEvents analysis was January 1, 2004 to March 31, 2011.

Lamictal Birth Defects Reported : Babies exposed to Lamictal during the first three months of pregnancy might have a higher chance of being born with a cleft lip or cleft palate

According to AdverseEvents, an average birth defect rate comparison between Lamictal and top Category D drugs yielded a surprising result; no meaningful differences were found. "These results indicate that regulatory bodies may want to consider category shifts for some of the most widely used antiepilepsy medications. Prospective studies, however, are needed to establish the exact incidence of these adverse events and to determine appropriate changes in category labeling, if any. This analysis warrants the attention of all healthcare providers and patients associated with epilepsy medications," a statement from AdverseEvents said.

On September 29, 2006, the FDA notified healthcare professionals and patients of new information from the North American Antiepileptic Drug Pregnancy Registry signifying that babies exposed to Lamictal, designated to treat seizures and bipolar disorder, during the first three months of pregnancy might have a higher chance of being born with a cleft lip or cleft palate. Women who are pregnant and are taking Lamictal or who are thinking about taking this medication are strongly urged to not start or stop taking the medication without first talking to their physician. More research is needed to be sure about the possibility of the increased chance of cleft lip or cleft palate developing in babies of pregnant women who take Lamictal.

On August 8, 2006 drug manufacturer GlaxoSmithKline warned pregnant women of the potential association between the drug Lamictal (generic: lamotrigine) and cleft palate or cleft lip in newborns. Lamictal gained FDA (Food & Drug Association) approval in 1994 and was approved by Health Canada in 1995. Lamictal is prescribed to combat epilepsy.

GlaxoSmithKline in conjunction with Health Canada stated that new statistics from a pregnancy registry recommend a correlation between taking Lamictal during the first trimester of pregnancy, and increased risk of cleft lip and/or palate in the baby. Based upon data from the public oral clefts is one of the most ordinary major birth defects, occurring at rates of 0.5 to 2.16 per 1,000 births. Data from the pregnancy registry illustrated three cases of cleft palate and two cases of cleft lip in infants born to 564 users Lamictal, a rate of 8.9 per 1,000.

Current patients taking Lamictal have been instructed to alert their doctors if they become pregnant or intend to become pregnant. Immediate stoppage of anti-eplieptic therapy may lead to breakthrough seizures with can cause serious risks for both the mother and the fetus and should be avoided. Peter Schram, a spokesman for GlaxoSmithKline, said other discontinuation symptoms could include rashes, dizziness, headaches, nausea and blurred vision.

Legal Help For Victims Affected By Lamictal

If you or a loved one has taken Lamictal while pregnant and you infant was born with a birth defect, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).

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