Actos Lawsuit

August 12th, 2011

Actos is a drug used to treat Type 2 (non-insulin-dependent) diabetes.  However, recent studies show that Actos can lead to serious injuries such as heart attacks, heart failure, and an increased risk of bladder tumors and cancer.  As a result, Actos lawsuits are being filed across the nation.

On August 23, 2010 a study published in Circulation: Cardiovascular Quality and Outcomes, shows that the risk of heart attack and acute heart failure from Actos is as great as Avandia.

Due to a study linking Actos and an increased risk of bladder tumors, France withdrew Actos from the Market in June 2011.  Citing a higher incidence of bladder cancer in Actos users, Germany advised doctors against prescribing the drug.

Based on the correlations found in these studies, the FDA updated the warning label of Actos, announcing a link between the drug and increased incidence of bladder cancer.

If you or someone you know took Actos, and has any type of heart of bladder problems, you should contact an attorney today to discuss your potential Actos lawsuit.

Warning: Nickel Allergies and the Amplatzer Septal Occluder

June 9th, 2011

Amplatzer devices are used to correct an atrial septal defect.  The Amplatzer septal occluder is delivered through a catheter, and the device expands to place a disc on either side of the defect, closing the hole between the left and right atria.

The Amplatzer device is comprised of nitinol, an alloy composed of 55% nickel and 45% titanium.  The dangers of this device stem from a patient’s allergic reaction to the nickel.  Nine percent of the population is allergic to nickel.

If you have nickel allergy and you’re exposed to a nickel-containing item, the allergic reaction (contact dermatitis) usually begins 12-48 hours after exposure. The reaction may persist for as long as 2-4 weeks.

Nickel allergy symptoms include:

  • Rash or bumps on the skin
  • Itching, which may be severe
  • Redness or changes in skin color
  • Dry patches of skin that may resemble a burn
  • Blisters and draining fluid in severe cases

Implantation of the Amplatzer occluder in patients with nickel allergies can result in serious complications.  Some patients even require additional surgery to remove the device.  If you have a nickel allergy, and had an Amplatzer occluder implanted, you could be eligible for an Amplatzer lawsuit.  Contact an experienced Amplatzer attorney today to assist you with your potential case.

Zoloft and PPHN

June 8th, 2011

Persistent pulmonary hypertension of the newborn (PPHN) is a serious complication for infants, causing substantial risk of death.  Recent studies have linked the use of anti-depressants, like Zoloft, to PPHN.

Persistent pulmonary hypertension is a dangerous lung condition that occurs soon after birth. Infants with PPHN have high pressure in their lung blood vessels, reducing the ability to transmit sufficient oxygen into their bloodstream.  Babies with PPHN usually require intubation and mechanical ventilation.

According to a public health advisory issued by the Food & Drug Administration, PPHN is six times more common in babies whose mothers take Zoloft after the 20th week of the pregnancy, compared to babies whose mothers do not take an SSRI-type anti-depressant.

Women who are pregnant or thinking about becoming pregnant should not stop any anti-depressant medication without first consulting their physician.  However, if you are taking Zoloft prenatally, you should talk to your doctor about the risk of Zoloft birth defects.  If you took Zoloft and have a child with PPHN, you may be eligible to file a Zoloft lawsuit.  For further information, contact a Zoloft lawyer today.

Celexa Heart Defects

June 8th, 2011

If you take Celexa early in your pregnancy, you may be doubling your risk that your infant will be born with a heart defect.   According to the American Journal of Obstetrics and Gynecology, fetuses exposed to Celexa during early pregnancy are more than twice as likely to be at risk for heart defects.

The study, performed in Denmark in 2009, reviewed more than 500,000 children born between 1996 and 2003.  According to the study, heart defects are more likely to be associated with anti-depressants such as Celexa.

Use of Celexa during early pregnancy (usually the first trimester) doubles the risk of a particular kind of heart defect.  Celexa heart defects usually affect the piece of tissue that separates the heart – called the septum.

The septum is a wall of tissue that separates the left side of the heart from the right side of the heart. Defects in the septum allow blood to flow from the left side of the heart to the right, reducing the heart’s efficiency.  Most septal hear defects can be surgically corrected.

If you or someone you know took this anti-depressant prenatally and has a child with a Celexa birth defect, you may be eligible for a Celexa lawsuit.  To find out more information, contact an experienced Celexa attorney today for a consultation.

Prozac and Pregnancy

June 8th, 2011

Prozac, if taken during pregnancy, may cause fetal abnormalities and perinatal complications.  Women taking Prozac should consult their medical provider before continuing the drug prenatally.

A California study performed in November 1996 evaluated 228 pregnant women who took Prozac.  The results of the study showed an increased incidence of three or more structural anomalies in babies exposed during the first trimester.  In addition, the use of Prozac showed an increased risk of poor perinatal condition and premature delivery.

Infants exposed to Prozac during the third trimester had higher rates of premature delivery, respiratory difficulty, cyanosis during feeding, and jitteriness, compared to normal infants.  Finally, infants whose mothers took Prozac prenatally had lower birth weights, as well as shorter gestation times.

If you took Prozac prenatally, and have a child with a Prozac birth defect, you may be eligible for a Prozac lawsuit.  For further information, contact an experienced Prozac attorney today to help you evaluate your potential case.

FDA Pregnancy Warnings

May 6th, 2011

The Federal Food & Drug Administration (FDA) has developed a list of pregnancy categories for prescription and over-the-counter drugs.  These warnings assist medical personnel in evaluating the risk of certain medications when taken prenatally.

Category A:  Studies have been done with first-trimester pregnancies and show no risk to the fetus.

Category B:  Animal studies prove the medicine to be safe, but there’s not enough human data yet.

Category C:  Animal studies prove the medicine to be harmful, but there is no human data.  These medications are still used if the benefit to the mother outweighs the risk to the fetus.

Category D:  There is a known risk to the fetus, but the benefit of the medicine to the mother may outweigh the risk in very rare circumstances.   These medications are used only if absolutely necessary.

Category X:  Known risk to the fetus outweighs any benefit to the mother.  Never use these medications during pregnancy.

A drug commonly used for treating migraines and epileptic seizures, Topamax, was recently shown to cause birth defects in children whose mother took the drug prenatally.  As a result of studies showing an 11 times greater risk of oral clefts, the FDA increased the pregnancy warning of Topamax to Category D.  As a result of the insufficient warnings, many people are filing Topamax lawsuits.

Taking Topamax Prenatally

May 6th, 2011

Certain medications are especially dangerous in first trimester (13 weeks).  For instance, the acne medication Accutane and certain antibiotics like tetracycline, can cause serious medical problems for an unborn baby.

Recent studies have shown that taking Topamax, an anti-convulsant used to treat migraine headaches and seizures, can cause serious birth defects.  In fact, women taking Topamax had 11 times more birth defects than average, most of them oral clefts such as cleft lip or cleft palate.  These malformations have led many people to file Topamax lawsuits, suing the manufacturers for insufficient warnings.

For many medications, the risk to the unborn baby must be weighed against the benefit to the mother’s health.  You healthcare provider can discuss alternative forms of treatment, if necessary.  In addition, be sure to tell your doctor all drugs you are taking, to prevent harmful interactions.

Many herbal remedies can be dangerous to your pregnancy as well.  For example, chamomile can increase the risk of miscarriage and fetal malformations.  Many herbs can increase the risk of uterine contractions, so ask your doctor before beginning any homeopathic treatment.

If you or someone you know took Topamax and have a child with a birth defect, you should contact an experienced Topamax attorney today for a free consultation.

FDA Approval Process

April 29th, 2011

How do drugs get approved for use?  Are all drugs thoroughly tested?  How does the public know certain drugs are safe?  What warnings are used to sufficiently notify the public?  These are all good questions to ask before you begin taking any type of prescription or over-the-counter drug.

The development and approval process for drugs is the Center for Drug Evaluation and Research (CDER), a division of the U.S. Food & Drug Administration.  CDER evaluates all new drugs before they are sold, evaluating their efficacy, as well as ensure that their health benefits outweigh their known risks.

Drugs are first tested in laboratories and on animals to evaluate safety.  Next, clinical trials are performed on people to determine whether the drug is safe, and to document any potential side effects.  The pharmaceutical company will send the results of these tests to CDER for evaluation.  If the drug is proven to be safe and effective, it will be approved.

Due to the dangers of clinical trials on pregnant women, many drugs lack information regarding the effects of taking the drug prenatally.  For example, the anti-seizure and migraine drug, Topamax, was recently show to cause serious birth defects in infants whose mothers took the drug while pregnant.  In fact, women taking Topamax had an 11 times higher rate of congenital birth defects.

Due to this new data, the Food & Drug Administration recently increased the pregnancy warning of Topamax to Category D, meaning there is positive evidence of fetal risk.  Though the warning has been updated, many children suffer Topamax birth defects due to this FDA-approved drug.

Thankfully, many parents are filing Topamax lawsuits to ensure that they obtain compensation for the defects caused by the drug.  If you or someone you know took Topamax prenatally, and has a child with a cleft lip or cleft palate, you should contact an experienced Topamax attorney today to assist you with your claim.

Increased Pregnancy Warnings for Topamax

April 27th, 2011

Studies show that 64 percent of pregnant women use at least one prescription drug during pregnancy.  However, with all prenatal drugs, doctors must weigh the potential benefits against the risk of possible fetal harm.  Unfortunately, little information exists because of the ethical issues surrounding clinical trials on pregnant women.

Many women may have taken the anti-convulsant, Topamax, for the prevention of seizures or migraine headaches.  On March 4, 2011, the Food & Drug Administration increased the pregnancy warning of Topamax to Category D, meaning there is positive evidence of fetal risk.  The previous designation was Category C because of lack of human data.

The new label states, “there may be an association between the use of Topamax during pregnancy and congenital malformations.”  A 2008 study published in Neurology found that women who took Topamax prenatally had a higher rate of babies born with cleft lips, cleft palates, or other congenital defects.  In fact, the rate of birth defects in women taking Topamax was 11 times higher than the normal rate.

Due to the insufficient pregnancy warnings, many women are filing Topamax lawsuits to seek compensation for their infant’s birth defects.  If you took Topamax prenatally, you should contact an experienced Topamax attorney today to assist you in evaluating your claim.

Taking Topamax Prenatally

April 22nd, 2011

Many women have concerns about taking medications during pregnancy.  Should you avoid all medications?  Which medications are safe?  What if you’re already taking a drug to treat an ongoing health condition?

Even innocuous over-the-counter medications, such as ibuprofen or aspirin, are not recommended for use during pregnancy.  If you have a health condition that requires regular medication, your doctor can evaluate whether it’s safe for you to remain on the drug.  Before you take any medication – prescription or over the counter – talk to your doctor first.

As a general rule, it’s best to use caution and avoid use of any medications during pregnancy.  Exposure to pharmaceuticals is thought to account for 2-3 percent of birth defects.  Some of the most dangerous drugs include the acne drug Accutane, the sleep aid/morning-sickness drug Thalidomide, and the psoriasis treatment Soriatane.

In addition, the anti-convulsant, Topamax, has recently been shown to cause severe congenital birth defects, such as cleft lip and cleft palate.  Earlier this year, the Food & Drug Administration strengthened warnings regarding Topamax during pregnancy.  If you took Topamax prenatally, and have a child with a birth defect, contact an attorney today to see if you qualify for a Topamax lawsuit.

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