February 13, 2012

Topamax used for weight loss - Is it worth the risk?

Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor's ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.

Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.

Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.

Why would any doctor prescribe Topamax for weight loss?

Continue reading "Topamax used for weight loss - Is it worth the risk?" »

February 12, 2012

Topamax used for weight loss - Is it worth the risk?

Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor's ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.

Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.

Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.

Why would any doctor prescribe Topamax for weight loss?

Continue reading "Topamax used for weight loss - Is it worth the risk?" »

January 10, 2012

Migraine Headache Rx Dangers

There’s nothing quite like a migraine headache. The sufferer just wants to lie down in a dark place and hope the pulsing throbbing pain on one side of his or her head subsides soon. Sometimes migraines come with vomiting, nausea and sensitivity to light and sound. Sometimes auras or distracting dots and numbness alert the sufferer to the imminent headache.

Migraine headaches are debilitating to the point of not doing chores or driving a car or going to work. Migraine headaches typically last from 4 to 72 hours.

Medications used to quell migraines fall into two categories:

• Pain-relieving medications - Drugs are taken during migraine attacks and are designed to stop symptoms that have already begun.
• Preventive medications - Drugs taken regularly, often on a daily basis, to reduce the severity or frequency of migraines.

Pain relieving medications include over the counter medications like Motrin, Advil, and Tylenol. Some prescription drugs are Axert, Zomig, Relpax, Migergot, and Cafergot.

Preventive medications don't eliminate headaches entirely, and some cause serious side effects like the anti-seizure drug Topamax. FDA approved the use of Topamax to prevent migraine headaches, but not to relieve the pain of migraines. Anti-seizure drugs may cause side effects like nausea and vomiting, diarrhea, cramps, hair loss, and dizziness.

Continue reading "Migraine Headache Rx Dangers " »

September 30, 2011

Topamax and Birth Defects to be Discussed at Mass Torts Made Perfect Seminar

Put it on your calendars, Anapol Schwartz attorney James Ronca will be speaking on “Topamax: What You Need to Know, The Science and the Litigation” from 10:45 am to 11:15 am at the semi-annual Mass Torts Made Perfect Seminar in Las Vegas, Nevada on October 13, 2011. The acclaimed national event for Pharmaceutical and Medical Device Mass Torts will celebrate its 10th anniversary at The Bellagio Hotel and Casino in Las Vegas.

Mr. Ronca is a vital part of Anapol Schwartz Dangerous Drug and Medical Device team and is intimately involved with Topamax litigation along with partner Sol Weiss, who is co-liaison counsel to the coordinated litigation. You can register for the event online here or by calling (800) 320-2227. The cost of registration is $1,395 for lawyers and $995 for paralegals or administrators for firms; a $300 discount is obtainable for all affiliates of The National Trial Lawyers.

Mass torts can be separated from other kinds of personal injury cases by numerous key attributes. For one, they employ large amounts of claims that correspond to one product. Secondly, regardless of the large number of individuals involved, there is a similar nature to the facts and legal implications of the cases. Thirdly, there is interconnectedness between all the separate cases. Such is the case with Topamax, a drug used to treat epileptic seizures and other disorders that has also been linked to causing birth defects. If you’ve been injured by Topamax or another dangerous drug, call 1-866-735-2792 to contact the Pennsylvania dangerous drug attorneys at Anapol Schwartz today.

April 18, 2011

Topamax Birth Defect: Information You Need to Know

In a previous blog post, we discussed the recent FDA announcement regarding new data linking Topamax and birth defects. We also explained cleft palate and cleft lip birth defects, which are collectively referred to as oral clefts, and how data suggests they are Topamax-caused birth defects. Topamax is used as anti-seizure medication for those who have epilepsy.

The severity of the Topamax oral birth defects can vary; ranging from a small notch on the infant’s lip to a groove running into the roof of their nose and mouth. Babies who are born with the cleft palate or cleft lip birth defect can have difficulty eating, talking, and may also have ear infections. Cleft palate treatment is available in which surgery is performed to close an infant’s lip and palate. After the cleft palate repair, most children do well.

According to the new data from the North American Antiepileptic Drug (AED) Pregnancy Registry, infants who are born to women taking Topamax had a 1.4 percent occurrence of oral clefts, which is significantly larger than the 0.38 percent – 0.55 percent occurrence in infants who were exposed to other antiepileptic drugs. Infants born to women who were not taking antiepileptic drugs only had an occurrence rate of 0.07 percent.

Based upon the new data, the FDA advises healthcare professionals to consider the risks and benefits of Topamax before prescribing it to women of childbearing age. They should also consider prescribing alternative medications with a lower risk of birth defects. The FDA has stated Topamax and its topiramate generic versions will have an updated, stronger warning on its prescribing information.

At Anapol Schwartz, our Topamax birth defect attorneys have a national reputation for successfully handling our clients' pharmaceutical liability claims. We are continuing to investigate Topamax and its effects on a woman’s first trimester of pregnancy. If you believe you have a valid Topamax lawsuit, please contact our law firm for a free consultation. Call 1-866-735-2792 today.

March 25, 2011

How to Repair Oral Clefts Caused by Topamax

Recently, the U.S. Food and Drug Administration announced new data which suggests that Topamax increases the chance a baby will be born with oral cleft birth defects, cleft lip and/or cleft palate, if their mother took the antiepileptic drug during her pregnancy. These risks are much less for babies whose mothers were taking other antiepileptic medication or were not taking medication at all while pregnant.

Oral clefts have many serious side effects, and infants born with these oral birth defects often have difficulty eating and gaining weight, which results in poor growth. Children can also suffer recurring ear infections and may have speech problems as a result of the defects.

Surgery is required to repair an oral cleft defect. When an infant is between six and 12-weeks-old, cleft lip repair is done. During the procedure, the baby will be given general anesthesia while a surgeon cuts and shapes the tissues and also sews together the lip. For cleft palate repair, the operation is usually done when a child is older, between nine and 12 months in order for the palate to be allowed to change as they grow. During this process, a surgeon will remove tissue from the roof of the child’s mouth to cover the soft palate while they are under general anesthesia. Often, an additional surgery will be needed to completely close the palate, and depending on their severity of their cleft and their surgery wound, another operation may be required to fix the scarring. In both operations, a surgeon may need to also repair the tip of the baby’s nose, which is called rhinoplasty.

As with any surgery that uses anesthesia, there are risks, which can include an adverse reaction to medication, difficulty breathing, bleeding, and infections. Cleft palate repair operations may also cause the bones in the middle of a baby’s face to grow incorrectly, as well as change the connection between their mouth and nose. Typically, most children heal with few complications.

After the oral cleft surgery, a baby will need to remain in the hospital for five to seven days. A complete recovery can take up to four weeks. The surgery wound will need to be very clean while it heals, and must not have any pressure put on it. In addition, any stretching of the healing area is prohibited for three to four weeks. Until the oral cleft wound is healed, the child will need to be on a liquid diet, and may need to wear an arm splint or cuff to control their arm movement. During this time it is crucial they do not put their hands in their mouth. Following an oral cleft operation, a child may need to see a dentist as their teeth may need to be corrected as they grow in, and may also need to see a speech therapist if there are muscle problems in their palate.

Surgically repairing oral cleft defects can be an expensive and traumatic process for your child and your family. If your child has suffered due to Topamax, call the Topamax cleft palate attorneys at Anapol Schwartz. We can help you determine whether you have a valid claim against the drug manufacturer. Call 866-735-2792 today.

March 12, 2011

Learning More about the Connection between Cleft Lip and Topamax

Cleft lip is an oral birth defect that is caused by the failure of the maxillary and medial nasal processes to properly fuse together during fetal development. Cleft lip can range in severity; from a small notch on a baby’s lip or to a complete split in a baby’s lip that goes all the way to the base of their nose. It can be one-sided or two-sided. In most cases of cleft lip, cleft palate is also present. Cleft palate is a birth defect that occurs when the two plates of the skull, which form the hard palate (the roof of a person’s mouth), are not completely joined together. Typically the soft palate is also affected. Cleft palate may also cause a gap in a baby’s jaw or a hole in the roof of their mouth. Often, the uvula is split. Cleft palate can affect one or both sides of a baby’s mouth and sometimes goes the full length of the palate. Together, these oral birth defects are referred to as oral clefts.

There are many serious side effects of cleft lips and cleft palates. Often these defects can cause a baby’s teeth to grow in misaligned, and it can also affect the shape of their nose. Other problems an infant may experience due to their oral cleft include difficulty eating, an inability to properly gain weight, poor growth, speech difficulties, recurrent ear infections, and more.

Recently, the U.S. Food and Drug Administration announced an oral birth defect warning after new data was released regarding a link between cleft lip and cleft palate and Topamax usage. According to the data, babies who are born to women who took Topamax during their pregnancy had a 1.4 percent occurrence rate of oral clefts. This rate is much more than the occurrence rate in babies who were exposed to other antiepileptic drugs, which was found to be between 0.38 and 0.55 percent. Babies who were born to women who did not take any antiepileptic drugs during pregnancy only had an occurrence rate of 0.07 percent. Typically, about 1 out of every 2,500 babies is affected by one or both of these oral birth defects.

According to the FDA, at least 4.3 million patients in the U.S. filled prescriptions for Topamax and its generic versions from January 2007 through December 2010. Many Topamax lawsuits are expected to be filed because of the antiepileptic drug’s extensive use.

Wondering whether you have a valid Topamax lawsuit against the drug manufacturer or negligent healthcare professional who failed to warn you regarding the drug’s dangers? Contact the Topamax lawyers at Anapol Schwartz. We can help you decide whether your claim is meritorious. Call 866-735-2792 to learn more.

March 11, 2011

Topamax Oral Clefts: Do I Need a Topamax Lawyer?

On March 4, the U.S. Food and Drug Administration announced new data that suggests that Topamax (topiramate), a medication used to treat certain types of seizures in individuals who have epilepsy, increases the risk that an infant will be born with the birth defects cleft palate and cleft lip when a mother takes the drug during their pregnancy.

Topamax is an antiepileptic medication the FDA approved to be used either alone or in addition to other medication to treat epilepsy. It has also been approved by the FDA to prevent migraine headaches, but not to ease migraine headache pain when they occur. Additionally, Topamax has been used by some for “off-label” or unapproved uses for other medical conditions, which the FDA says may not be regarded as serious.

According to the new data, a link between Topamax and oral clefts has been found. Babies who were born to mothers who took Topamax during their pregnancy had a significantly higher occurrence rate of oral clefts than babies born to mothers who took other antiepileptic medication or no medication whatsoever during their pregnancy.

Cleft palate and cleft lip, commonly referred to collectively as oral clefts, occur when parts of a fetus’ palate or lip do not fuse together properly during the early part of the first trimester of their mother’s pregnancy. This time is particularly dangerous as most women do not know they are pregnant during their first trimester, which makes the potential fetal risk of Topamax oral clefts all the more hazardous if a woman of childbearing age does not know they should consult a healthcare professional regarding the drug. Oral clefts are serious birth defects that have severe side effects, including difficulty eating, poor growth, speech problems, recurrent ear infections, and more.

How prevalent is Topamax usage? The FDA reports that about 32.3 million prescriptions for the drug and its generic forms were dispensed between January 2007 and December 2010, and roughly 4.3 million patients filled prescriptions for the drug from pharmacies in the United States. Due to its widespread use, many Topamax lawsuits are expected to be filed.

Do you need a Topamax lawyer? If your baby was born with an oral cleft and you were taking Topamax or another drug during the pregnancy, you may have a viable Topamax lawsuit. If a healthcare professional failed to adequately warn you of the risks of Topamax and did not inform you of alternative medications, the healthcare professional may be held legally responsible for your baby’s birth defect. To learn how the Topamax lawyers at Anapol Schwartz can help you, call 866-735-2792 today.

March 9, 2011

Topamax Cleft Palate: FDA Announces Heightened Risk

Recently, the U.S. Food and Drug Administration (FDA) announced new data suggesting that Topamax (topiramate) and its generic versions increase the risk for an infant to be born with the birth defects cleft palate and cleft lip if their mother used the medication during pregnancy. However, it is important to note that women who are currently taking Topamax or any of its generic forms should not stop doing so unless directed by a healthcare professional, even if they are pregnant. Ceasing a 25 mg, 100 mg, or 200 mg dosage of Topamax can cause severe health problems.

Topamax is used in treatment for certain kinds of seizures in people who have epilepsy. The drug is also approved to be used to prevent migraine headaches. The FDA reports the drug has been used for unapproved uses for other conditions which may not be considered to be serious.

Collectively referred to as oral clefts, cleft palate and cleft lip are birth defects that occur when parts of a fetus’ lip or palate do not fuse together completely in the early part of the first trimester of a woman’s pregnancy. Most women are not aware that they are pregnant during the first trimester, thus making the potential risk of Topamax cleft palate all the more hazardous.

As more news and information about Topamax birth defects becomes available, the Topamax oral cleft defect lawyers at Anapol Schwartz will keep our readers updated. Be sure to check back with our blog this month as we discuss this dangerous drug and Topamax birth defects. If you have any questions regarding whether you have a Topamax lawsuit, call our injury attorneys today at 1-866-735-2792 for a free consultation.