The United States Food and Drug Administration (FDA) came out with a statement Wednesday, June 15 2011 warning that the diabetes medication Actos (generic: pioglitazone) increases the risk of bladder cancer by no less than 40% if Actos is used for longer than a year, or with higher dosages of Actos. There have been suspicions for some time now that Actos causes bladder cancer, but the FDA’s recent release makes the claims suggesting a correlation between diabetes drug Actos and cancer even stronger.

Going forward, the Food and Drug Administration (FDA) is requiring modifications to Actos’ drug label in order to portray the recent findings that Actos may significantly increase the risk of bladder cancer. Actos is manufactured by drug-maker Takeda Pharmaceutical North America. This release by the FDA is a major blow to the class of diabetes medications known as thiazolidinediones, which Actos is a part of. Avandia, another diabetes medication in the same class, has also been under fire lately due to reports that Avandia causes increased risk of cardiovascular disease.

As of now, the US FDA is not taking any further action against Actos other than mandatory label changes until further test results return. Actos has already been suspended in France, and officials in Germany have warned physicians not to prescribe Actos to new patients. The Food and Drug Administration (FDA) announced back in September 2010 that Actos was under investigation, and these warnings are a result of those tests.

The data which suggests an increased risk of bladder cancer with Actos comes from an ongoing 10-year study of over 190,000 diabetes patients. The increased risk of bladder cancer specifically comes to those who have taken Actos for more than a year or who have taken larger dosages. A French study showed a 22% increase in risk of bladder cancer to those who had ever taken Actos at all. The French study revealed a 75% increased risk of bladder cancer for those who had taken a cumulative dosage of over 28,000 milligrams of Actos.

Actos Bladder Cancer Lawsuit

If you or a family member took Takeda Pharmaceutical’s drug Actos (pioglitazone) and you have developed bladder cancer, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action in a potential Actos bladder cancer lawsuit against the makers of the drug.

Please fill out our online legal evaluation form to the right or call 1-800-883-9858 and we will contact you within 4-12 hours for a free confidential case review. Contact our law firm immediately so that we may explain the rights and options available to you and your family.

According to a recent release by the Food and Drug Administration (FDA), the epilepsy drug Topamax has been associated with the development of oral cleft birth defects like cleft palate and cleft lip. The study suggests that the increased risk of cleft lip and cleft palate might be as much as 16 times higher than those not taking Topamax while pregnant.

A study conducted by the North American Antiepileptic Drug Pregnancy Registry discovered that approximately 1.4% of infants whose mothers were on Topamax during the first trimester of pregnancy developed oral clefts like cleft palate or cleft lip. Approximately .4% of children developed oral cleft birth defects whose mothers were on different epilepsy drugs. Only .07% of infants whose mothers were not on epilepsy medication during pregnancy developed oral cleft birth defects like cleft lip or cleft palate.

Topamax Information:

• Topamax Cleft Lip and Cleft Palate Lawsuit
• Topamax Recall
• Topamax and Spina Bifida
• Topamax Birth Defect Lawsuits
• Topamax Cleft Lip Lawsuits
• FDA Strengthens Topamax Birth Defects Warning
• FDA: Migraine Drug Topamax Ups Risk for Oral Birth Defects
• FDA Alert: Topamax Oral Clefts Risk in Infants
• Topamax Cleft Palate Lawsuits
• Topamax (Topiramate) – Birth Defects Update

Cleft Lip

A cleft lip often looks like a hole or indentation in the lip which can possibly extend all the way to the nose. A cleft lip can happen on either side of the mouth, or even on both sides. In some cases, cleft lip can be detected via prenatal ultrasound, but more often than not, cleft lip is diagnosed during a physical exam after birth.

An earlier study released in the journal Neurology stated that the rate of children who had developed cleft lip is 11 times higher in those whose mothers took Topamax while they were pregnant. Cleft lip is treatable, but it may require multiple surgeries beginning as early as 3 months after birth. In some cases, treatment for a cleft lip might extend into a patient’s teenage years.

Cleft Palate

A cleft palate forms when certain plates in the skull which are meant to form a hard palate, or the mouth’s roof, don’t form correctly. Cleft palate can cause a hole or gap in the roof of the mouth or between the soft and hard palate, potentially causing a hole in the patient’s jaw.

Usually an infant will only develop either a cleft lip or a cleft palate, but in some cases, both cleft lip and cleft palate can be present at the same time. There are operations which fix cleft palate by refusing the palate and nasal passage. Typically this surgery is supposed to be undergone before an infant is a year old. In some cases of cleft palate, the infant may need a tube to be inserted into their ear prior to the surgery to avoid hearing loss.

Topamax: Oral Cleft Complications

In most cases, oral clefts like cleft lip and cleft palate will develop within the first trimester of pregnancy. The following are some examples of potential complications resulting from oral cleft disorders:

• Trouble feeding
• Small, missing or extra teeth
• Difficulty socializing
• Middle ear infections
• Hearing loss
• Trouble speaking or vocalizing
• Psychological, emotional or behavioral difficulties

Topamax Oral Cleft Birth Defects Lawsuit: Speak to an Attorney

Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Topamax may be linked to causing the development of birth defects in unborn babies, infants, and children when their mothers took antidepressants while pregnant.

Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Topamax cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Topamax during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).

As of yet, the anti-seizure drug Topamax has not been recalled as a whole by the Food and Drug Administration (FDA). In order for there to be a large-scale Topamax recall, there would have to be significant evidence showing that Topamax poses a serious health risk to a majority of its users. At this time, this is not the case for Topamax, although there has been scientific evidence suggesting that a significant portion of patients are at a higher than normal risk of having children with certain birth defects if taking Topamax during pregnancy.

There was, however, a recall of approximately 57,000 bottles of Topamax due to reports of bad odors coming from the medication. This Topamax recall occurred in April of 2011. The Topamax recall was of 57,000 bottles of Topamax 100mg tablets. It was reported that the Topamax recall likely occurred because of some wood preservative getting into the Topamax bottles. Traces of chemical byproduct TBA (2, 4, 6 tribromarnisole) were found in the containers which is a commonly used wood preservative in shipping palates.

Topamax Information:

• Topamax Cleft Lip and Cleft Palate Lawsuit
• Topamax Recall
• Topamax and Spina Bifida
• Topamax Birth Defect Lawsuits
• Topamax Cleft Lip Lawsuits
• FDA Strengthens Topamax Birth Defects Warning
• FDA: Migraine Drug Topamax Ups Risk for Oral Birth Defects
• FDA Alert: Topamax Oral Clefts Risk in Infants
• Topamax Cleft Palate Lawsuits
• Topamax (Topiramate) – Birth Defects Update

Topamax Birth Defects

While there hasn’t been a full Topamax recall yet, recent data and actions by the Food and Drug Administration have suggested that there may be some risks to taking Topamax while pregnant. Topamax was recently changed from being a pregnancy category C drug to a pregnancy category D drug by the Food and Drug Administration (FDA). Topamax had previously been a pregnancy category C drug for the 15 years since its introduction.

A pregnancy category C drug means that the drug might have some potentially dangerous side effects, but there has only been evidence of the side effects during animal trials. Pregnancy category D drugs have shown significant scientific data in human studies that the drug (Topamax in this case) may cause damage to an unborn human fetus.

A recent study, referenced in the Food and Drug Administration’s (FDA) warning stated that approximately 1.4% of infants born to mothers taking Topamax while pregnant develop an oral cleft defect such as cleft lip or cleft palate. This is compared with approximately .4% of infants born to mothers taking other epilepsy medications and only .07% of infants born to mothers not taking any anti-seizure medication.

Topamax Birth Defects Lawsuit: Speak to an Attorney

Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Topamax may be linked to causing the development of birth defects in unborn babies, infants, and children when their mothers took antidepressants while pregnant.

Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Topamax cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Topamax during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).

FDA Alters Topamax’s Status

Topamax is an FDA approved medication for the treatment of seizures. It is also commonly used for ‘off-label’ conditions such as obesity, bipolar disorder, and others. Recently, the FDA released a warning changing Topamax’s status from a pregnancy category C drug to a pregnancy category D drug. As a pregnancy category C drug, Topamax was acknowledged to have some risk, but these risks had only been established in animal tests and that there was not enough data in human studies. Now that Topamax is a pregnancy category D drug, the FDA acknowledges that Topamax has shown evidence in human studies that it can cause damage to a human fetus.

It has been established that Topamax likely increases the risk of oral cleft defects such as cleft palate and cleft lip, and Topamax might also contribute to other birth defects such as heart defects and spina bifida.

Topamax Information:

• Topamax Cleft Lip and Cleft Palate Lawsuit
• Topamax Recall
• Topamax and Spina Bifida
• Topamax Birth Defect Lawsuits
• Topamax Cleft Lip Lawsuits
• FDA Strengthens Topamax Birth Defects Warning
• FDA: Migraine Drug Topamax Ups Risk for Oral Birth Defects
• FDA Alert: Topamax Oral Clefts Risk in Infants
• Topamax Cleft Palate Lawsuits
• Topamax (Topiramate) – Birth Defects Update

Spina Bifida

Spina bifida is a neural tube defect (NTD). Neural tube defects typically develop during pregnancy. A neural tube defect is an opening in the spinal cord or brain that happens early on in human development. The spinal cord or an embryo begins as a flat area, which becomes a tube (neural tube) approximately 28 days after conception. If the neural tube does not close completely, it may develop a neural tube defect (NTD) such as spina bifida. Usually, the neural tube defect (NTD) or spina bifida will have developed before a woman even knows that she is pregnant.

There are two main types of neural tube defects (NTD). The most common type of neural tube defect is called an open neural tube defect (NTD). Open neural tube defects occur when the brain or spinal cord are exposed at the time of birth via a defect in the vertebrae or skull. Spina bifida is an example of an open neural tube defect (NTD). Closed neural tube defects are rarer than open. Closed neural tube defects occur when the defect is covered by skin. Some examples of closed neural tube defects include lipomyelomeningocele, lipomeningocele, and tethered cord.

Topamax Spina Bifida Lawsuit: Speak to an Attorney

Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Topamax may be linked to causing the development of birth defects in unborn babies, infants, and children when their mothers took antidepressants while pregnant.

Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Topamax cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Topamax during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).

A new study warning released by the Food and Drug Administration (FDA) states that taking the epilepsy medication Topamax while pregnant increases the risk of oral cleft birth defects like cleft palate and cleft lip.

The research uncovers data which suggests that the risk of those oral cleft birth defects when taking Topamax during pregnancy increases by as much as 16 times.

If you or a loved one took Topamax during pregnancy and have had a child suffering from a birth defect, you may be entitled to compensation through a Topamax birth defects lawsuit.

Topamax Information:

• Topamax Cleft Lip and Cleft Palate Lawsuit
• Topamax Recall
• Topamax and Spina Bifida
• Topamax Birth Defect Lawsuits
• Topamax Cleft Lip Lawsuits
• FDA Strengthens Topamax Birth Defects Warning
• FDA: Migraine Drug Topamax Ups Risk for Oral Birth Defects
• FDA Alert: Topamax Oral Clefts Risk in Infants
• Topamax Cleft Palate Lawsuits
• Topamax (Topiramate) – Birth Defects Update

Topamax has been approved by the Food and Drug Administration (FDA) to treat seizures associated with epilepsy and to aid in the prevention of migraines. In some cases, however, doctors may prescribe Topamax in an off-label manner to treat things like obesity, bipolar disorder, and alcoholism.

According to Russel Katz, MD, the director of the Division of Neurology Products in the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, “Health care professionals should carefully consider the benefits and risks of Topamax when prescribing it to women of childbearing age. Alternative medications that have a lower risk of birth defects should be considered.”

Utilizing data taken from the North American Antiepileptic Drug Pregnancy Registry, the Food and Drug Administration (FDA) states that 1.4% of children who were exposed to Topamax during pregnancy developed a cleft palate or cleft lip, compared to approximately .4% of those who were exposed to other epilepsy medications during pregnancy. For infants whose mothers don’t take any type of epilepsy medication during pregnancy, the incidence of cleft palate and cleft lip is much lower (.07%).

Similar data has appeared in studies conducted in European countries.

Higher Pregnancy Warning By The FDA

Because of the recently surfaced information about Topamax potentially causing oral cleft birth defects, the Food and Drug Administration (FDA) has declared that Topamax must have a stronger caution on its label. Topamax has been changed from a pregnancy category C drug to a pregnancy category D drug. Pregnancy category C means that there has been data suggesting fetal damage in animal studies but that there is not enough data in human studies. Category D means that there has been adequate data in human studies to suggest that Topamax may cause fetal damage.

Oral cleft birth defects such as cleft palate and cleft lip happen when portions of the lip or palate are not properly fused together during the first trimester of pregnancy. The severity of oral cleft birth defects may range from being minor, like a small notch in the lip, to a large groove that goes into the roof of the mouth and nose which may lead to issues with eating, talking, and even ear infections.

Food and Drug Administration workers suggest that pregnant women and women who are at a childbearing age should consider other treatment options and discuss them with their doctors before taking Topamax. Women who take Topamax should let their doctor know immediately when they are pregnant or considering becoming pregnant.

Topamax Birth Defect Lawsuits: Speak to an Attorney

Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Topamax may be linked to causing the development of birth defects in unborn babies, infants, and children when their mothers took antidepressants while pregnant.

Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Topamax cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Topamax during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).

FDA Diflucan Warning

The FDA has just released a safety warning (August 2011) dealing with the drug Diflucan (fluconazole) and the potential birth defects that Diflucan may cause. The studies conducted by the FDA suggest that Diflucan, typically used to treat yeast infections of the throat, esophagus, mouth, or vagina could possibly be causing birth defects when Diflucan is taken repeatedly by pregnant mothers in their first trimester.

Diflucan is also sometimes used as a preventative treatment for patients who are likely to get a yeast infection. The FDA’s statement said that the findings do not show a higher rate of birth defects from mothers who have a single small (150mg) dosage of Diflucan, rather when the mother takes repeated and larger dosages (400-800mg).

The warning issued by the FDA does, however, affect those taking higher dosages of Diflucan more than once. The frequent usage of higher doses of Diflucan has been associated with a group of rare and dangerous birth defects in the infants of mothers who took Diflucan during most or all of the first trimester of their pregnancy. The risks of Diflucan are less pronounced or not as well known when the mother takes only a single smaller dose of Diflucan while pregnant.

To this point, there have been multiple cases published reporting infants who suffer from birth defects after their mothers took frequent and higher dosages of Diflucan during the majority of the first trimester of their pregnancy.

Because of these reported cases of increasing numbers of birth defects in Diflucan babies, the FDA has seen fit to modify Diflucan’s pregnancy rating. Previously, all Diflucan usage was a pregnancy category C drug. Now, Diflucan, when taken multiple times in larger dosages, is a pregnancy category D drug. This means that there have been reported cases with human data suggesting that Diflucan may cause birth defects. Diflucan taken a single time in a smaller dosage is still considered a pregnancy class C drug.

The FDA’s research also suggests using caution when giving Diflucan to a nursing mother.

Some of the rare birth defects being documented in infants of mothers who took large dosages of Diflucan during the first trimester may include:

• A short, broad head
• Abnormal looking face
• Oral cleft (cleft palate)
• Bowing of the thigh bones
• Thin ribs and long bones
• Muscle weakness and joint deformity
• Congenital (present at birth) heart disease

Diflucan Birth Defects Lawsuit: Speak to an Attorney

Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The drug Diflucan may be linked to causing the development of birth defects of unborn babies, infants, and children when their mothers took them while pregnant.

Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Diflucan cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an Diflucan during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).

Recently, an El Paso woman filed a transvaginal mesh lawsuit against American Medical Systems (AMS) due to issues with her vaginal mesh implant manufactured by American Medical Systems (AMS). She received the AMS vaginal sling in June 2009 in order to fix vaginal tissue.

After the surgery for her pelvic organ prolapse (POP), she endured extreme pain, issues with her urinary system and was required to endure more surgeries to take out the AMS transvaginal mesh. She filed her complaint in Los Angeles Superior Court against American Medical Systems (AMS) and some other unnamed manufacturers. Her lawsuit claims that the transvaginal mesh sling eroded, shrunk and part of the sling protruded into her vagina. Her case claims that American Medical Systems (AMS) did not warn patients adequately of the risks of vaginal mesh complications and side effects. She claimed that American Medical Systems (AMS) should be responsible due to strict liability, negligence, and a breach of an implied and express warranty, as well as fraud, misrepresentation, and a violation of California’s consumer protection laws.

Vaginal Mesh Erosion Lawsuits

• ObTape Lawsuit
• Vaginal Mesh Erosion Warning by the FDA
• Bladder Sling Mesh Erosion Lawsuits
• ObTape Mesh Erosion Lawsuits
• Vaginal Mesh, Bladder Slings and ObTape Lawsuits
• Transvaginal Mesh Lawsuits

Several other American Medical Systems (AMS) transvaginal mesh lawsuits have been filed by women experiencing severe complications after receiving surgery implanting transvaginal mesh products to correct their pelvic organ prolapse (POP). In 2008 the FDA issued a warning saying that in ‘rare cases’ severe side effects and complications may result after implanting transvaginal mesh products. In 2011, the FDA revised their statement to say that it is no longer rare for patients to experience such complications. Some complications from transvaginal mesh products include pain during sex, urinary incontinence, and not fixing the pelvic organ prolapse (POP).

Last year, multiple individuals reached settlements through Mentor ObTape transvaginal mesh lawsuits after experiencing severe complications with the products. The Mentor ObTape is made by a subsidiary of Johnson & Johnson. The lawsuits claimed that the rate of complications with the Mentor ObTape vaginal mesh product may be as high as 18%. The Mentor ObTape vaginal mesh has since been removed from the market.

Recently there have been an increasing number of Bard Avaulta transvaginal mesh lawsuits filed by women experiencing transvaginal mesh complications with those products. The lawsuits claim that Bard Avaulta’s transvaginal mesh products were negligently designed and that the manufacturer did not warn patients about the potential complications and transvaginal mesh side effects.

If you or a loved one received a transvaginal mesh product from American Medical Systems (AMS) or another manufacturer and you are experiencing complications with the device, you may be entitled to financial compensation.

Transvaginal Mesh Lawsuits: Speak to an Attorney

Many patients suffering from transvaginal mesh injuries wish that they had been warned of the risks and potential complications before undergoing the operation. Our product liability law team at the Willis Law Firm is committed to getting you answers and financial compensation for your medical expenses, loss of income, physical pain, and emotional suffering. Transvaginal mesh products currently linked with transvaginal mesh injuries include:

• Bard Avaulta Solo
• Avaulta Plus
• Avaulta Biosynthetic Systems

If you or a loved one is suffering from transvaginal mesh injuries please call the Willis Law Firm. We have female consultants standing by, trained to discuss sensitive issues confidentially. We are currently accepting Transvaginal Mesh Injuries lawsuits nationwide. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).