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Prescription Drug Claims

Just as with other commercial products, drugs marketed to the public may be defectively designed, manufactured or marketed to the public in a manner that exposes consumers to unreasonable risks. If you have reason to believe that you have been injured by the use of any pharmaceutical drug, you should consult with your doctor immediately and consider contacting an attorney. Some of the more noteworthy drugs that have been the subject of serious safety concerns are the following:

Accutane (isotretinoin)
Actos (pioglitazone)
Avandia (rosiglitazone)
Celexa (citalopram) use causing abnormal heart rhythms
Gilenya (fingolimod)
Lexapro (Escitalopram) and Celexa (citalopram) use by children
Neurontin (gabapentin)
Oral Osteoporosis Drugs (bisphosphonates)
Ortho Evra Birth Control Patch
Pradaxa (dabigatran)
Risperdal (risperidone)
SSRI birth defects
Topamax (topiramate)

Accutane (isotretinoin) – Accutane is a drug prescribed for the treatment of a specific type of severe acne (severe recalcitrant nodular acne) that is not responsive to other therapies. On November 23, 2004, the Food and Drug Administration (FDA) announced that it was strengthening the risk minimization action plan for Accutane and its generic equivalents with the goal of reducing the risk of birth defects associated with fetal exposure to the drug. On November 18, 2004, FDA researcher Dr. David Graham testified before Congress that Accutane should be scrutinized to determine whether the drug should continue to be marketed in the United States.  The iPledge Program was introduced by the FDA in 2005 to try to ensure that female patients receiving the drug do not become pregnant.  If you took this drug during your pregnancy and there were any complications in your pregnancy causing harm to your unborn child, or if your child was born with a birth defect, you should consult with an attorney. 

Actos (pioglitazone) – Actos is a diabetes medication.  On June 15, 2011, the FDA announced that use of the drug for more than a year may be associated with an increased risk of bladder cancer.  The warning was based on a review of the interim results of 10 year study that will be completed in late 2012.  The 5 year results from the study reflected an increased risk of bladder cancer among patients with the longest exposure to the drug and to the highest cumulative doses.  The FDA also acknowledged a a French study purporting to show a link between the use of the drug and higher bladder cancer rates, resulting in the suspension of the drug’s distribution in France and the decision not to commence use of  the drug with new patients in Germany.  If you were diagnosed with bladder cancer after using Actos, you should consult with an attorney.

Avandia (rosiglitazone) -- Avandia, also marketed under the names Avandamet and Avandaryl, is a diabetes medication.   On September 17, 2010, the FDA announced that it was significantly restricting the use of the drug to patients with Type 2 diabetes who cannot control their diabetes on other medications. The new restrictions were in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.  The FDA has now limited the use of Avandia and other rosiglitazone medicines to patients already being successfully treated with these medicines, and patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact). Healthcare providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines and the drug is no longer available through retail pharmacies.  If you suffered a heart attack or stroke after taking Avandia, Avandamet or Avandaryl, you should consult with an attorney.

Celexa (citalopram) use causing abnormal heart rhythms – Celexa is a selective serotonin reuptake inhibitor (“SSRI”) is an antidepressant.  In August 2011, the FDA issued a drug safety communication indicating that the drug should not be used at doses greater than 40 mg. a day could cause dangerously abnormal electrical heart activity.  If you or a loved one were taking Celexa and suffered injuries resulting from an abnormal heart rhythm, you should consult with an attorney.

Gilenya (fingolimod) – Gilenya is a drug used for relapsing forms of multiple sclerosis (MS) in adults.  On May 14, 2012, the FDA reported that it had completed its investigation of a report of a patient who died after taking the first dose of the drug.  Although the FDA could not conclusively link the drug to any deaths, the agency remained concerned about the cardiovascular effects of the drug after the first dose.  For this reason, the FDA now advises against its use by patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications.  If you or a loved one suffered injury as a result of a cardiovascular event after using Gilenya, you should consult with an attorney.

Lexapro (Escitalopram) and Celexa (citalopram) use by children – Escitalopram and citalopram are both selective serotonin reuptake inhibitors (“SSRI”s) approved by the FDA for the treatment of major depressive disorder.  In 2009, the federal government joined in a lawsuit against the manufacturer, Forest Laboratories, alleging that the drugs were illegally marketed for use by children at a time when the drugs were not approved for such use by the FDA (Lexapro was approved for use for acute and maintenance treatment of Major Depressive Disorder in adolescents, 12 - 17 years of age, on March 19, 2009).  The company subsequently agreed to settle the civil case and to plead guilty to criminal charges relating to the promotion of Celexa for use by children.  If your child took Celexa or Lexapro between 2002 and 2009 and was under 18 at the time that he or she took it, and if you believe your child suffered any adverse consequences as a result of his or her use of the drug, you should consult an attorney.

Neurontin (gabapentin) – Gapapentin was approved by the FDA in 1994 for use to help control partial seziures.  In 2002, an indication was added for treating neuropathic pain resulting from shingles.  However, the drug was allegedly marketed agressively for certain off-label uses and was frequently prescribed for certain psychiatric conditions, such as bipolar disorder.  The FDA black box warning for the drug now states: “antiepileptic drugs (AEDs), including Neurontin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.”  In 2010, in the first reported settlement of a Neurontin-related suicide claim, the manufacturer Pfizer agreed to pay approximately $400,000 to the family of a man who committed suicide in 2002.  If you know of a loved one who committed suicide following use of the drug, you should consult with an attorney.

Oral Osteoporosis Drugs (bisphosphonates) -- Bisphosphonates, sold under various brand names including Fosamax, Actonel, Boniva, Atelvia, Didronel and Skelid, are commonly used to treat or help prevent osteoporosis and for certain bone diseases such as Paget’s disease.  On March 10, 2010, the FDA issued a safety announcement to address public concerns about a possible increased risk of subtrochanteric femur fractures – fractures in the bone just below the hip -- for users of bisphosphonates.  The FDA indicated that the data it had reviewed did not show a clear connection at that time. On September 14, 2010, the FDA issued another advisory noting that a task force formed by the American Society of Bone and Mineral Research had recommended product labels alerting doctors and patients to this potential risk with long-term use of bisphosphonates.  On October 3, 2010, the FDA issued another advisory acknowledging that “although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.”

On July 21, 2011 the FDA issued a drug safety communication indicating that it was conducting an ongoing review of data to determine whether the use of bisphosphonates was associated with an increased risk of esophageal cancer.  The FDA indicated that the largest studies that the FDA had reviewed at that time were two epidemiologic studies using one patient database (the U.K. General Practice Research Database or GPRD). One study found no increase in the risk of esophageal cancer. The second study found a doubling of the risk of esophageal cancer among patients who had 10 or more prescriptions of the drugs, or who had taken the drugs over 3 years. The FDA reported that other external researchers investigating this issue, using different patient databases, have reported no increase in risk, or a reduced risk. 

If you have used bisphosphonates and experienced either of these medical conditions – a subtrochanteric femur fracture or esophageal cancer – you should consult with an attorney.

Ortho Evra Birth Control Patch – This popular birth control patch was approved by the FDA in 2001.  The patch’s manufacturer has been sued in numerous courts, with the lawsuits commonly alleging that the patch posed an increases risk of adverse advents such as blood clots, pulmonary emboli and deep vain thrombosis, causing, among other things, strokes and heart attacks.  Many of the current cases have been consolidated in an action currently being conducted in the Northern District of Ohio.   If you were a user of the Ortho Evra patch and suffered any of the medical events discussed above, you should consult with an attorney.

Pradaxa (dabigatran) – Pradaxa is an oral anticoagulant (blood thinner) used to prevent strokes in persons suffering from atrial fibrillation due to causes unrelated to malfunctioning heart valves.  Based on data from seven clinical trials, Cleveland Clinic researchers have determined that patients in the study who were using Pradaxa had a 33% higher risk of heart attack or severe symptoms of heart disease than patients taking warfarin (Coumadin).  The FDA is also investigating a large number of reports of serious bleeding allegedly linked to the drug.  If you have used Pradaxa and subsequently suffered a heart attack or other severe symptom of heart disease, or suffered a permanent injury as a result of internal bleeding, you should consult with an attorney.

Risperdal (risperidone) – Risperdal is an antipsychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder and irritability associated with autistic disorder.  However, the FDA does not recommend the use of the drug for elderly patients with dementia-related psychosis, as drug trials revealed a risk of death in drug treated patients of between 1.6 and 1.7 times the risk of death in placebo treated patients.  Most of the deaths appeared to be either cardiovascular or infectious in nature. Elderly users of the drug who subsequently experienced these sorts of medical events should consult with an attorney. 

SSRI birth defects – A class of antidepressants referred to as selective serotonin reuptake inhibitors (“SSRI”s), includes a variety of widely prescribed drugs, such as Zoloft, Lustral and Serlain (sertraline), Paxil (paroxetine), Prozac (fluoxetine), Effexor (venlafaxine), Wellbutrin (bupropion), Lexapro (ecitalopram), Celexa (citalopram) and Symbyax (fluoxetine and olanzapine).  In 2005, the labeling for Paxil was changed to reflect findings in a study that exposure to the drug in the first trimester of pregnancy may increase the risk of fetal birth defects.  In 2006, the FDA issued a public advisory warning that a study had found that babies born to mothers taking SSRIs after their 20th week of pregnancy were six times more likely to be born with a potentially life threatening lung problem, persistent pulmonary hypertension (“PPHN”). According to  a 2011 FDA advisory, there have been more recent studies with conflicting results, with one study reflecting an elevated risk of PPHN for babies born to mothers using SSRIs during the first trimester of pregnancy, and other studies finding no elevated risk.  Another recent study found that newborn babies were more likely to have seizures if their mothers used an SSRI during pregnancy.  If you took an SSRI during your pregnancy and your child was born with a birth defect, you should consult with an attorney.

Topamax (topiramate) – Topiramate is a drug used for the treatment of epileptic seizures and migraine headaches. On March 4, 2011, the FDA issued a safety alert about the increased risk of the development of cleft lip and/or cleft palate in babies born to women treated with Topamax during pregnancy.  If you were taking Topamax during your pregnancy and you child suffers from either of these birth defects, you should consult an attorney.


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Law Offices of Sands White & Sands, PA
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