Topamax Birth Defects

The US Food and Drug Administration (FDA) has issued a warning about the risk of Topamax side effects including a risk of Topamax birth defects in children exposed to Topamax prior to birth. These Topamax oral birth defects include a risk of cleft lip and cleft palate. Because of the risk of Topamax cleft palate or cleft lip, the FDA has requested that Topamax carry a stronger warning and announced it will change Topamax from Pregnancy Category C to Pregnancy Category D.

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Topamax And Pregnancy

Topamax, known generically as topiramate, is approved by the FDA to treat certain types of seizures and to prevent migraine headaches. Based on new research, the FDA suggests that health care professionals strongly weigh the benefits and risks of topiramate when prescribing it to women who are of childbearing age, and Topamax will now be classified as a Pregnancy Category D drug. Part of the problem is that oral clefts occur when parts of the lip or palate do not completely fuse in the first trimester of pregnancy—before some women even know they are pregnant.

Topamax Cleft Palate and Cleft Lip

In making its announcement, the FDA cited research from the North American Antiepileptic Drug (AED) Pregnancy Registry, which suggested an increased risk of oral clefts—including cleft lip and cleft palate—in infants who were exposed to Topamax and its generic counterparts during the first trimester. According to the data, infants who were exposed to topiramate experienced a 1.4 percent prevalence of oral clefts, whereas infants who were exposed to other antiepileptic medications had 0.38 - 0.55 percent prevalence. Infants who are not exposed to any antiepileptic medications had a 0.07 percent prevalence of oral cleft.

Following an analysis of this data, the FDA has determined that Topamax will be moved from Pregnancy Category C to Pregnancy Category D. Pregnancy Category D means that there is evidence of human fetal risk based on human data but the benefits of the drug in some pregnant women may still outweigh the risks.

Topamax Side Effects

In addition to the risk of Topamax cleft palate or cleft lip, there are a number of other potential Topamax side effects. Some of these include:

Constipation or diarrhea
Dizziness
Headache
Nausea, stomach pain or upset stomach
Flu-like symptoms, runny nose, sore throat
Loss of appetite

More severe Topamax side effects may include:

Severe allergic reactions such as rash; hives; itching; difficulty breathing; tightness in the chest, swelling of the mouth, face, lips, or tongue
Blood in the urine
Blurred vision, double vision or other vision changes, eye pain
Bone pain, chest pain, muscle or joint pain, severe stomach, side or back pain
Confusion, decreased coordination
New or worsening mood changes: anxiety, depression, hostility
Menstrual changes, cramps
Red, swollen, peeling or blistered skin
Irregular heartbeat, loss of consciousness
Rapid, shallow breathing
Severe or persistent loss of appetite, significant weight loss
Suicidal thoughts or actions
Tremors
Trouble walking
Unexplained fever
Unusual bruising or bleeding
Unusual eye movements
Unusual tiredness

You should seek medical attention immediately if you experience any severe Topamax side effects.

Topamax (Topiramate) Label Change for Cleft Lip & Cleft Palate

The patient medication guide and the prescribing information for Topamax will be updated to provide patients with the new information regarding Topamax birth defects--particularly Topamax cleft lip and topamax cleft palate.

Oral cleft defects, which include cleft lip and cleft palate, can lead to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Women who are pregnant or planning on becoming pregnant and taking Topamax or topiramate should speak with their doctors to discuss their treatment options.

Topamax is sold by Johnson & Johnson but is also available in generic versions. Johnson & Johnson said it is working with the FDA to update the label.

Topamax Recall

In April 2011, Johnson & Johnson recalled two lots of Topamax after receiving complaints about an uncharacteristic odor from the medication. According to The Wall Street Journal (04/14/11), the Topamax recall affects approximately 57,000 bottles of 100 milligram Topamax tablets, shipped in October and December 2010. The odor that resulted in the Topamax recall was linked to temporary gastrointestinal symptoms but no reports of serious health effects.

The problem is reportedly linked to chemically-treated wooden pallets. The company is investigating whether other products were affected by the same problem, believed caused by TBA, a chemical used to treat wooden pallets.

Topamax Cleft Palate & Topamax Cleft Lip Legal Help

If you or a loved one has suffered damages in this case as a result of taking Topamax or topiramate, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

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Last updated on Oct-4-11

TOPAMAX ARTICLES AND INTERVIEWS

FDA Advisory Panel Discusses Topamax Side Effects

Washington, DC: On September 23, 2011, an advisory panel for the US Food and Drug Administration (FDA) met to discuss Topamax side effects and side effects of other medications in children. The focus of the meeting was safety reviews of Topamax side effects in children. Results of the advisory committee meeting about topiramate side effects are not yet available, although the FDA did issue background material prior to the meeting [READ MORE]

Concerns about Topamax Side Effects Raised

Houston, TX: While concerns have been raised about the risk of Topamax side effects, especially the risk of Topamax side effects in children, a recent study has failed to find similar risks in newer antiepileptic medications. That could mean that newer drugs may be safer to use during pregnancy than Topamax, although researchers reportedly did not find evidence of a risk of major birth defects in infants exposed to Topamax. The US Food and Drug Administration (FDA), however, has issued a warning about the risks associated with exposing a fetus to Topamax [READ MORE]

Johnson & Johnson Eyes New Oversight Panel in Light of Topamax Side Effects

Trenton, NJ: Johnson & Johnson, which has dealt with a number of recalls and heavy criticism over Topamax side effects and other products with quality control issues in recent years, reportedly plans to create a new oversight panel [READ MORE]