What is Lexapro?

Escitalopram, more commonly known by its brand name “Lexapro,” is one of many medications prescribed for the treatment of major depressive disorder (MDD). Lexapro belongs to a category of antidepressants called SSRIs (selective serotonin reuptake inhibitors), along with the popular medications Zoloft, Prozac, Celexa, and Paxil. SSRIs are believed to affect moods by restoring chemical imbalances in the brain involving serotonin. At this point in time, over eighteen million adults in the US have been prescribed Lexapro; in some cases Lexapro is prescribed to adolescent patients too. Recently the safety of using SSRI medications like Lexapro during pregnancy has been called into question, and many researchers believe that doing so can result in severe side effects in the form of congenital defects to the developing fetus.

Can I take Lexapro During Pregnancy?

The United States Food and Drug Administration currently puts prescription drugs into various categories based on their perceived risk to the mother and developing child. The Pregnancy categories range from “A” (no harm to mother or fetus) to Catgory “X” (should not ever be taken during pregnancy). Lexapro and other SSRI antidepressants are in Category “C,” meaning that animal testing suggests harm to fetus, but adequate clinical research does not yet exist for humans. This means that currently, despite reliable postulation that Lexapro taken during pregnancy can cause side effects to a fetus, it can still be prescribed to pregnant women.

Types of Lexapro Pregnancy Side Effects

Selective Serotonin Reuptake Inhibitors are linked to an increased risk of many different harrowing birth defects including, but not limited to the following:

• Congenital Heart Defects
• Persistent Pulmonary Hypertension
• Abdominal Defect
• Cranial Skull Defects
• Neural Tube Defects
• Club Foot/Bilateral Club Feet

Lexapro Pregnancy Side Effect Lawsuits

Many of the side effects that can potentially occur when a woman takes Lexapro during any part of her pregnancy necessitate intensive and expensive neonatal care. Some require invasive surgical treatments, and a lifetime of careful monitoring by specialized medical professionals. Furthermore, having a child born with any, or a combination of these birth defects creates extreme emotional distress. Many female patients are not adequately warned of Lexapro Pregnancy Side Effects prior to conceiving a child. As a result hundreds of lawsuits have been filed against the pharmaceutical companies that make SSRI medications, like Lexapro.

Took Lexapro During Pregnancy – Talk to a Lexapro Lawyer

Did you take an SSRI antidepressant like Lexapro at any time during a pregnancy? Was your child born with any of the adverse side effects mentioned above? If you answered yes to these questions, you may be eligible for a Lexapro Pregnancy Side Effect Lawsuit. Call the Willis Law Firm today to have your potential claim evaluated confidentially and free of charge by a Top Trial Lawyer with the Highest Peer Rating Licensed to Practice in both Texas and New York. The Willis Law Firm is currently accepting antidepressant pregnancy side effects cases nationwide; call us today.

What is Lexapro?

Lexapro, generic name Escitalopram, is a type of prescription antidepressant medication distributed by Forest Laboratories, Inc. Lexapro is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) that work by restoring chemical balances in the brain that are believed to affect mood. Other popular SSRI prescriptions include Paxil, Zoloft, Prozac, and Celexa. To date, Lexapro has been prescribed to somewhere over 18 million adults in the United States for the treatment of depression, anxiety, and several other conditions. Sometimes Lexapro is used in the treatment of adolescents as well.

Lexapro Birth Defects

Although Lexpro is used for the treatment of mood disorders, it has recently been the subject of several research projects which seek to establish a link between Lexapro taken during pregnancy and the following adverse birth effects. Lexapro (and other SSRI) use during the 1st trimester of pregnancy is associated with following increased risks of congenital defects: Omphalocele (6X), Anal atresia and limb reduction defects (4X), and Septal defects (2X). Other reported birth defects and congenital heart defects to children born to women that took Lexapro (and other associated SSRIs) during fetal development include, but are not limited to the following:

• Atrial or Ventricular Septal Defects (Holes in the Heart Wall)
• Heart Valve Defects
• Neural Tube Defects (including Spina Bifida)
• Persistent Pulmonary Hypertension (PPHN)
• Hypoplastic Left Heart Syndrome (HLHS)
• Autism Spectrum Disorder
• Transposition of Great Arteries (TGA)
• Coarctation of the Aorta (CoA)
• Tetrology of Fallot (TOF)
• Pulmonary Valve Stenosis (PVS)
• Club Foot/Bilateral Club Feet
• Double Outlet Right Ventricle (DORV)
• Abdominal Defects (including Omphalocele)
• Cranial Skull Defects (Craniosynostosis)
• Ebsteins Anomaly
• Patent Ductus Arteriosus (PDA)
• Total Anomalous Pulmonary Venous Return (TAPVR)

Many of these conditions require surgery or hospitalization for treatment, while others require a lifetime of monitoring and care. The costs to a family dealing with any one or combination of these conditions includes not only financial costs, but also emotional and physical costs as well. For this reason, a Lexapro Pregnancy lawsuit is often a good method when seeking financial compensation for these types of suffering.

Lexapro Pregnancy Lawsuit – Talk to a Lawyer

If your child was born with serious birth defects and the mother was taking Lexapro (or any other SSRI antidepressants, anti-psychotic or seizure and/or epilepsy medications) throughout any part or all of the pregnancy, call this Willis Law Firm for a Free & Confidential Antidepressant Lawsuit Assesment. You and your child may have grounds for a Lexapro lawsuit that could result in monetary compensation for their injuries. Call today to get information about filing a Lexapro Pregnancy Lawsuit, and help hold manufacturers responsible for the damages caused by their dangerous drugs.

Combined oral contraceptive pills, commonly referred to as “the pill” are one of the most frequently chosen birth control methods, with more than 100 million women using some variety of this method worldwide. Using this type of birth control method does carry with it some additional health risks, including several types of potentially harmful blood clots. However, it has recently been discovered that Yaz, a specific type of COC that uses a synthetic progestin called drospirenone carries with it 2-3 times the risk of developing blood clots when compared against other types of birth control pills. In the wake of this information, many women have filed lawsuits against Bayer, the company that manufactures Yaz, due to misleading claims by the company regarding the safety and usefulness of its product.

Types of Yaz Blood Clots

Bayer’s Yaz has been linked to more than one type of blood clot. While all combined oral contraceptive pills can increase the risk of blood clots, Yaz has been shown to multiply these risks 2-3 times. Also, many young women with no prior existing risk of blood clots have experiences debilitation in relation to blood clots after taking Yaz. The following medical complications have been reported as occurring following the prescription of Yaz:

Venous Thrombosis: blood clot that forms inside of a vein.

Deep Vein Thrombosis (DVT): type of blood clot that forms in the veins furthest from the body’s surface and can break off and travel throughout the body.

Pulmonary Embolism: when a blood clot forms in a deep vein and travels back to the lungs; very serious and potentially fatal if not treated quickly.

Ischemic Stroke: a type of stroke that occurs when the blood flow to the brain is interrupted by a blood clot; can occur as a “thrombotic stroke” or an “embolic stroke.”

Yaz FDA Warning

After the release of two misleading television advertisements for Yaz, the United States Food and Drug Administration sent a formal warning letter to Bayer regarding its deceptive statements. In the commercials, it was alleged that Yaz was not only effective in preventing pregnancy, but also for the treatment of PMS as well as acne. In reality, Yaz was never medically proven to treat either. It was shown to be helpful in treating a more severe type of disorder called Premenstrual Dysphoric Disorder (PMDD), but was never evaluated as a treatment for PMS. The FDA found these commercials to be highly misleading and demanded that Bayer cease to air them. In response, Bayer actually spent $20 million airing new commercials which retracted these statements.

File a Yaz Blood Clot Lawsuit: Speak to an Attorney

If you or a loved one has suffered from blood clots or other injuries related to the prescription of Yaz, call the attorneys at the Willis Law Firm today for a case review free of charge and free of obligation. You may be eligible for financial compensation through filing a Yaz blood clot lawsuit. Currently our firm is accepting Yaz cases on a national level, and you will never be billed any legal fees unless we make a successful recovery for you. Call us today.

Pradaxa Lawsuit – Pradaxa Internal Bleeding Lawsuits

Recently many individuals have begun to file Pradaxa Internal Bleeding Lawsuits because they are suffering negative effects from the drugs. Studies have been published which show that within Pradaxa’s first year on the market there were more than 260 reported deaths attributed to Pradaxa Internal Bleeding. Speak to a Board Certified Personal Injury Trial Lawyer today by contacting the Willis Law Firm to discuss the legal options available to you and your family.

Pradaxa Lawsuit – Pradaxa Cerebral Hemorrhaging Lawsuits

A Pradaxa Cerebral Hemorrhage occurs when the bursting of an artery in the brain causes blood to pool and put stress on the surrounding brain tissue. It is a very dangerous condition which may lead to death. Research shows that popular anticoagulant medication Pradaxa may cause cerebral hemorrhaging among its patients. If you or a family member has suffered from a cerebral hemorrhage that you believe may be caused by Pradaxa, you may be entitled to financial compensation from the makers of the drug. Please contact the Willis Law Firm to review your potential Pradaxa Lawsuit.

Pradaxa Attorney: Discuss Filing a Pradaxa Lawsuit

If you, or a loved one, were prescribed Pradaxa and have suffered any of the following: acute coronary syndrome, heart disease, uncontrolled bleeding, internal bleeding, bleeding in the brain, cerebral hemorrhaging, stroke, or death, you may be entitled to monetary compensation. Call the Willis Law Firm today to have your potential Pradaxa Lawsuit evaluated free of charge. All Pradaxa cases are handled via a contingency fee basis, so the client will not be charged an attorney or legal case expense unless a recovery is made. Speak to a Board Certified Personal Injury Trial Lawyer today by contacting the Willis Law Firm to discuss the legal options available to you and your family.

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For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

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Studies indicate Yaz may increase your risk of a Stroke

Although there are many factors that can potentially increase a person’s risk of suffering a stroke, the popular birth control pill Yaz has been linked to a higher risks of this and other serious complications. Sometimes referred to as a “brain attack,” a stroke is what happens when the flow of blood to the brain is obstructed. The type of the stroke and the amount of time that the blood flow is blocked are the two major factors that affect the damage caused by a stroke. Birth control pills in general elevate the risk of a woman developing blood clots (which can lead to a stroke), but a new type of oral contraceptive that includes drospirenone has been shown to multiply this risk 2-3 times when compared with other birth control pills. Bayer’s Yaz is one of these types of pills.

Link Between Yaz and Increased Risks

Taking any oral contraceptive can increase the risk of developing a stroke, and these risks are usually highest in women who are above the age of thirty five and smoke. However, taking a birth control pill that includes drospirenone, a synthetic progestin, increases these risks by about 2-3 times as much. Bayer, the pharmaceutical company that manufactures and produces Yaz, denies any of these risks and continues to maintain that its product is as safe and effective as other birth controls. However, Yaz and other oral contraceptives that include drospirenone are currently the subject of an ongoing FDA investigation due to conflicting findings between various studies.

Yaz Lawsuits

Whether Yaz results in a stroke or another medical complication, the results can be devastating. Yaz side effects can result in permanent disability, and some are even potentially fatal. Many women who have had their lives changed by the injuries they suffered after taking Yaz respond by filing a Yaz lawsuit against Bayer. These lawsuits allege that Bayer was aware of these higher risks and failed in its responsibility to alert consumers. Some of the Yaz lawsuits even claim that Bayer concealed existing evidence that suggested its product carried higher risks.

File a Yaz Stroke Lawsuit Today: Speak to a Lawyer

If you have suffered a stroke or other medical complication while taking the prescription oral contraceptive Yaz, you may have a legal right to financial compensation through a Yaz lawsuit. Call the Willis Law Firm today, and we will provide you with an initial Yaz consultation completely free of charge or obligation. Our talented team of legal professionals is currently accepting birth control side effects cases on a contingency fee basis in all 50 states regarding the following oral contraceptives:

Yaz (generic names Gianvi and Loryna)

Yasmin (generic names Ocella, Syeda, and Zarah)

Yaz has become the subject of thousands of lawsuits after the release of medical studies suggesting that it might double or even triple the risk of developing blood clots. Originally marketed as a “safer” type of birth control that also cured PMS and acne, new evidence is suggesting exactly the opposite. One woman, interviewed by ABC news said that she had initially switched to Yaz hoping that it would help with her PMS symptoms. However, within three months of beginning to take Yaz, the otherwise healthy woman suffered a massive double pulmonary embolism. En route to the hospital, her heart stopped beating. Fortunately she was revived, but the woman stayed in a coma for nearly 2 weeks. When she awoke, the woman was blind, and she remains blind to this day. This woman filed a lawsuit against Bayer, the company responsible for Yaz, because she believes that the drug was responsible for the blood clot that created the injuries she suffers from today.

Yaz FDA Warning

To date, four independent studies have been conducted that suggests that oral contraceptive pills that contain drospirenone, an ingredient present in Yaz, increase the risk of developing blood clots. These studies vary in the rate of increase, but range from an increase of 1.5 to 3 times chance of blood clot when compared against older pills that do not contain drospirenone. Blood clots can result in complications ranging from difficulty breathing, strokes, and can even be potentially fatal. Upon being presented with the data from these four independent studies regarding Yaz and blood clots, the United States Food and Drug Administration decided to open up its own investigation with its own study. The results have not yet been released.

Yaz Side Effects Lawsuit

When many women discover that the medical complications they are suffering are due to being prescribed Yaz, they decide to file a Yaz side effects lawsuit. These lawsuits are filed on the basis that Bayer should have been aware of the potentially increased risk of developing blood clots and advised the public and medical professionals regarding these increase risks. However, it has actually been alleged that Bayer was aware of these risks and tried to conceal related information. Two studies funded and performed by Bayer found no additional risk of blood clots, while four studies performed by independent teams did find an increased risk of blood clots.

File a Yaz Lawsuit: Speak to an Attorney

Did you suffer a blood clot or other injury while taking the oral contraceptive Yaz? If so, you may be eligible for financial damages through filing a Yaz Lawsuit. Call the Willis Law Firm today in order to have your potential claim evaluated for free by a talented and aggressive legal team led by a top Texas Trial Lawyer with the highest peer review rating. We are currently accepting Yaz, Yasmin, and Ocella cases in all fifty states; call for your free case review today.

What is Cleft Palate?

Cleft palate is one of the most common birth defects. The definition of a ‘cleft’ is an opening or splitting of the upper lip, roof of the mouth (palate) or both of these defects. Cleft palate happens when the facial structures are developing during pregnancy and they don’t entirely close.

Cleft palate often occurs as an isolated birth defect, without other birth defects. However, there are often other birth defects found along with cleft palate. Recent research, including a study conducted by the National Birth Defects Prevention Study claim that certain birth defects like cleft palate may be caused by the prenatal use of antidepressants like Effexor when taken during the early stages of pregnancy.

Cleft palate typically leaves behind a certain level of scarring, depending on when the defect is discovered and corrected.

Cleft Palate Symptoms

Common cleft lip/palate symptoms and problems include:

• Chronic ear infections
• Problems speaking
• Eating issues
• Poorly shaped nose
• Crooked teeth
• Low weight

The cleft in a baby is typically identifiable immediately at the time of birth. Cleft palate may affect either or both portions of the face. Cleft palate may only be small or it may go all the way from the lip through the upper gum and palate into the lower portion of the infant’s nose.

Sometimes the cleft appears in the muscles of the soft portion of the palate at the rear of the mouth covered by the lining of the mouth. Due to its hidden nature, a cleft in the soft portion of the palate might not be diagnosed at birth.

Other symptoms may include:

• Trouble feeding
• Nasal regurgitation
• Excessive gassiness

About Effexor

Effexor (Venlafaxine) was introduced to the market in 1994. It is considered a Serotonin-norepinephrine reuptake inhibitor (SNRI). Effexor is typically used to treat major anxiety disorders and depression. There is not a lot of information presently available about the side effects and complications of Effexor other than that it is a Pregnancy Category C drug, as noted by the Food and Drug Administration. Class C category drugs have shown adverse effects in clinical trials with animals, but there is presently not enough evidence from human trials. This could mean that there simply have not been any human tests, or that the tests have not shown adequate evidence.

Effexor Cleft Palate 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 Effexor 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 Effexor 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 Effexor 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).

What is Anencephaly?

Anencephaly is a congenital (present at birth) birth defect which involves missing a large portion of the brain and skull. Anencephaly is considered a neural tube defect and is one of the most common neural tube defects. Neural tube defects (NTDs) are defects present at birth which damage the tissue which becomes the spinal cord and the brain.

Anencephaly typically happens in the early stages of development of the fetus. Anencephaly occurs when the higher portion of the neural tube does not close correctly. The exact cause of anencephaly is unknown, but recent research suggests that it is more common with the use of certain antidepressants such as Effexor taken early in pregnancy. Another potential cause is a low intake of folic acid by the pregnant mother.

Anencephaly currently happens in approximately 1 of every 10,000 births in the United States. The exact number of cases is not known because many fetuses with anencephaly result in miscarriages. Having one child with anencephaly may result in an increased risk of having more children with the birth defect.

Symptoms of Anencephaly

Some common symptoms of anencephaly in newborn infants may include some or all of the following:

• Lack of portions of the skull
• Lack of portions of the brain (cerebral hemispheres and cerebellum)
• Abnormalities of facial features
• Heart defects

About Effexor

Effexor (Venlafaxine) was introduced to the market in 1994. It is considered a Serotonin-norepinephrine reuptake inhibitor (SNRI). Effexor is typically used to treat major anxiety disorders and depression. There is not a lot of information presently available about the side effects and complications of Effexor other than that it is a Pregnancy Category C drug, as noted by the Food and Drug Administration. Class C category drugs have shown adverse effects in clinical trials with animals, but there is presently not enough evidence from human trials. This could mean that there simply have not been any human tests, or that the tests have not shown adequate evidence.

Effexor Anencephaly 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 Effexor 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 Effexor 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 Effexor 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).

Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, Amturnide® and all Aliskiren Based Products Alert

On Decemeber 20, 2011 Novartis announced that the above drugs may cause serious and potentially life threatening side effects particularly for patients with Type 2 diabetes when taken with ACE & ARB drugs, including stroke, kidney damage, high potassium, low blood pressure and possible death. (See below)

Patient Safety Alert – December 20, 2011

Novartis has suspended promotion of Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, Amturnide®, Aliskiren® after terminating a study in patients with Type 2 diabetes and renal impairment who are also at high risk of cardiovascular and renal events after researchers saw an increased number of adverse events including non-fatal stroke, kidney complications, hyperkalemia and hypotension. An increased number of adverse events potentially caused by the drugs were found in a drug trial that was terminated according to Novartis and other sources on December 20, 2011. These adverse events increased when the drugs were given in combination with the heart/cardiovascular treatment ACE (angiotensin converting enzyme) and ARB (angiotensin receptor blocker) drugs. Patients with Type 2 diabetes are particularly at risk. Variations of the drug in combination with others may include HCT (hydrochlorothiazide) valsartan and/or amlodipine.

Potential side effects include:

• Stroke
• Heart Attack / Cardiac Injury
• Renal Failure
• Kidney Damage
• Kidney Failure
• Hyperkalemia (high potassium / irregular heart beat)
• Hypotension (low blood pressure)

NOTE: Novartis indicates that patients should not cease taking these drugs without consulting with their health care professional. If any drug reaction, side effect or injury occurs, seek medical treatment immediately. If you have any questions about these drugs and you medical care or possible health effects, then talk to you Doctor. If you are having serious or life threatening complications, call for medical attention immediately.

Tekturna Lawsuit, Valturna Lawsuit and Aliskiren Lawsuits

If you or a loved one have taken Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, or Amturnide® and suffered a stroke, heart attack, kidney damage, kidney failure, been diagnosed with high potassium or low blood pressure, then call our law firm to discuss a possible lawsuit, or claim for monetary damages for the injuries you have suffered. Talk to a Board Certified Personal Injury Trial Lawyer with over 25 years of personal injury trial experience. Call for a Free and Confidential Case Consultation regarding your injuries and losses.

Talk to a Lawyer – Toll Free 1-800-883-9858 or Click Here

Novartis Press Release

Novartis announces termination of ALTITUDE study with Rasilez®/Tekturna® in high-risk patients with diabetes and renal impairment.

• ALTITUDE study involved patients with type 2 diabetes and renal impairment who are at high risk of cardiovascular and renal events
• Committee overseeing study identified higher adverse events when Rasilez/Tekturna was added to an ACE or ARB drug in this patient population
• Patient safety is the highest priority and Novartis is in dialogue with health authorities worldwide. Patients should contact their health care provider if they have any concerns
• Assessment of results of the ALTITUDE study and the potential implications for Rasilez/Tekturna-based products* is ongoing

Basel, December 20, 2011 – Novartis announced that following the seventh interim review of data from the ALTITUDE study with Rasilez®/Tekturna® (aliskiren), a decision to terminate the trial has been taken on the recommendation of the independent Data Monitoring Committee (DMC) overseeing the trial. The DMC concluded that patients were unlikely to benefit from treatment added on top of standard anti-hypertensives, and identified higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial. Specifically, in the trial arm in which Rasilez/Tekturna was added to the standard of care there was an increased incidence after 18-24 months of non-fatal stroke, renal complications, hyperkalemia and hypotension in this high-risk study population. The placebo-controlled Phase III ALTITUDE study is the first trial to investigate Rasilez/Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. These patients are known to be at high risk of cardiovascular and renal events. In the study, Rasilez/Tekturna was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Novartis is in ongoing discussions with health authorities worldwide about the implications of the findings from ALTITUDE for patients. As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB.

“Patient safety is the highest priority for Novartis, and we are in a dialogue with health authorities worldwide,” said David Epstein, Division Head of Novartis Pharmaceuticals. Novartis is recommending that ALTITUDE investigators remove Rasilez/Tekturna-based products from their patients’ treatment regimen and review their high blood pressure medication. Novartis is also reviewing the findings with DMCs of other clinical studies involving Rasilez/Tekturna-based products and combination therapies. 2/3

Patients in ALTITUDE should contact their study site for guidance on medication and should not stop treatment until they have seen their physician in view of the importance of controlling high blood pressure. Any patients using Rasilez/Tekturna or other aliskiren combination products who may have questions about their medication should consult their healthcare provider. For more information visit www.novartis.com.

Total sales of Rasilez/Tekturna-based products for the first nine months of 2011 were USD 449 million (1% of Novartis Group sales) and are likely to be negatively impacted by the study results going forward. Product profitability in 2011 was negative. A further update of the actual financial implications will be communicated when the regulatory dialogue has been concluded.

About Aliskiren

Aliskiren was approved in 2007 in the EU and US under the brand-names Rasilez and Tekturna respectively, for the treatment of hypertension (high blood pressure) either as monotherapy or in combination with other medications. The efficacy and safety of Rasilez/Tekturna have been investigated in more than 57,000 patients who have been treated with this medicine in clinical studies.

Rasilez/Tekturna-based products include:

• Rasilez®/Tekturna®
• Rasilez HCT®/Tekturna HCT®, a single-pill combination of Rasilez/Tekturna and hydrochlorothiazide (HCT)
• Valturna®, a single-pill combination of Rasilez/Tekturna and valsartan, available in the US only
• Rasilamlo®/Tekamlo®, a single-pill combination of Rasilez/Tekturna and amlodipine
• Rasitrio®/Amturnide®, a triple combination of Rasilez/Tekturna, amlodipine and hydrochlorothiazide (HCT)

About ALTITUDE

ALTITUDE was a multinational study in 8,606 patients from 36 countries evaluating the potential benefits of Rasilez/Tekturna to reduce the risk of cardiovascular and renal events in this patient population. ALTITUDE was the first randomized, double-blind, placebo-controlled study to investigate Rasilez/Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. These patients are known to be at high risk of cardiovascular and renal events. In the study, Rasilez/Tekturna was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).

Talk to a Lawyer – Toll Free 1-800-883-9858 or Click Here

Tekturna® Dear Doctor Letter by Novartis

Date: December 20, 2011 9:15:42 AM CST
Subject: Urgent message about Aliskiren Speaker Programs
Novartis Pharmaceuticals Corporation

Dear Doctor:
Novartis is writing to inform you that as a precautionary measure, in the best interest of patients, we have temporarily ceased promotion of Tekturna and all aliskiren-based products for use in combination with an ACE or ARB. This includes ceasing promotion of Valturna.

We have subsequently suspended all branded and unbranded promotional educational programs supporting Tekturna, Tekturna HCT, Tekamlo, Amturnide and Valturna.

Healthcare professionals should not combine an Aliskiren containing product with an ACE or an ARB. Therefore healthcare professionals should switch patients who are on Tekturna or any aliskiren-based products, in combination with an ACE or an ARB, to an alternative anti-hypertension regimen. This includes switching all patients on Valturna to an alternative therapy. This change should take place as soon as medically feasible, consistent with patient safety and the prescribing physician’s clinical judgment.

These actions are being taken following an interim review of data from the ALTITUDE clinical trial. This was the first study to investigate Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. In the study, Tekturna was given in addition to optimal cardiovascular treatment including an ACE inhibitor or ARB.

Novartis was informed that the independent Data Monitoring Committee (DMC) overseeing ALTITUDE had recommended stopping the trial because Tekturna was unlikely to show any benefit, and potential safety concerns had been identified in these high-risk patients. Specifically, Tekturna was associated with an increased risk of non-fatal stroke, renal complications, hyperkalemia, and hypotension.

In view of the unexpected study findings, a decision was taken to terminate the ALTITUDE study. Patient safety is the highest priority for Novartis and we are in dialogue with health authorities worldwide. We are now assessing the results of the ALTITUDE study and the potential implications for aliskiren-based products.

Sincerely,
Marjorie Gatlin
Head, Cardiovascular/Metabolism & Inflammation Medical Unit
Novartis Pharmaceuticals Corporation

Tekturna® and Valturna® Lawsuit

If you or a loved one have taken Tekturna®, TekturnaHCT®, Valturna®, Tekamlo®, or Amturnide® and suffered a stroke, heart attack, kidney damage, kidney failure, been diagnosed with high potassium or low blood pressure, then call our law firm to discuss a possible lawsuit or claim for monetary damages for the injuries you have suffered. Talk to a Board Certified Personal Injury Trial Lawyer with over 25 years of personal injury trial experience. Call for a Free and Confidential Case Consultation regarding your injuries and losses.

Contact a Tekturna® and Valturna® Injury Lawyer

A recent study was published about the potential dangers of taking prescription drug Effexor during pregnancy. The study was conducted by the National Birth Defects Prevention Study (NBDPS) and was supported by funding from the United States Center for Disease Control (CDC). The need for this study was determined by the fact that so many pregnant mothers take antidepressants like Effexor during pregnancy and there was not much available information about Effexor at the time.

About Effexor

Effexor (Venlafaxine) was introduced to the market in 1994. It is considered a Serotonin-norepinephrine reuptake inhibitor (SNRI). Effexor is typically used to treat major anxiety disorders and depression. There is not a lot of information presently available about the side effects and complications of Effexor other than that it is a Pregnancy Category C drug, as noted by the Food and Drug Administration. Class C category drugs have shown adverse effects in clinical trials with animals, but there is presently not enough evidence from human trials. This could mean that there simply have not been any human tests, or that the tests have not shown adequate evidence.

Effexor Birth Defects

• Effexor Coarctation of the Aorta Lawsuit
• Effexor Atrial Septal Defect Lawsuit
• Effexor Ventricular Septal Defect Lawsuit
• Spina Bifida Lawsuit
• Anencephaly Lawsuit
• Cleft Palate Lawsuit
• Effexor Gastroschisis Lawsuit

Congenital Birth Defects

Congenital (present at birth) defects are a major problem in the United States, with 1 in every 33 babies being born with some type of birth defect. These birth defects greatly increase the risk of lifelong disabilities or even premature mortality.

The purpose of the National Birth Defects Prevention Study (NBDPS) was to determine if the use of Effexor during pregnancy is associated with any specific birth defect or class of birth defects. The study is an on-going, case-control study of major birth defects. Currently they are collecting data from California, Utah, Texas, Iowa, Arkansas, Georgia, North Carolina, New Jersey, Massachusetts, and New York.

The data gathered from the National Birth Defects Prevention Study (NBDPS) suggests that there are associations between prenatal use of Effexor and certain birth defects. They declared that some of the observations might be chance findings and they suggest that more studies be conducted on the risk of Effexor and birth defects.

Effexor 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 Effexor 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 Effexor 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 Effexor 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).