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Depression Drugs Could Be Dangerous for Expecting Moms
Have you taken a prescribed drug to help combat depression during pregnancy?
It is fairly common for expecting mothers to experience some form of depression. Babyzone.com reports that 10 to 20% of women show signs of depression during pregnancy, with 20% of those being serious cases.
Many doctors routinely prescribe drugs called Serotonin Reuptake Inhibitors (SSRIs) to treat depression in pregnant women.These drugs include Prozac, Paxil, Zoloft, Celexa, Effexor, and Cymbalta, among many others.
Reports stemming back to 2006 in the New England Journal of Medicine have made note of the potential complications for newborns whose mothers have taken these drugs in the final trimester of their pregnancy. According to ACOG, some of the less serious complications can include: jitteriness, mild respiratory distress, excessively rapid respiration, weak cry, poor muscle tone, and admission to the neonatal intensive care unit.
One of the most concerning complications from this drug interaction is Persistent Pulmonary Hypertension (PPHN) in newborns. This disorder severely restricts arteries, causing a lack of oxygen to the bloodstream. This lack of oxygen can cause strain to all of the newborn’s organs, including the brain.
PPHN is normally discovered within the first few hours after birth. Although it is treatable, PPHN can still cause serious and potentially deadly problems, including breathing difficulties, seizures, and developmental disorders.
If you are currently taking an SSRI during pregnancy, consult with your doctor to determine the steps necessary to keep both your baby and yourself as healthy as possible.
If you think that your child may have been affected by the use of an SSRI, please contact Gersowitz Libo & Korek, P.C. at 800-529-9997 or email info@lawyertime.com for a free consultation.
How Safe are Off-Label Prescriptions?
Drug Used to Treat Post-Traumatic Stress Disorder for Soldiers May Be Deadly
Seroquel, an anti-psychotic drug approved by the Food and Drug Administration (FDA) to treat schizophrenia, bi-polar disorders, and depression, has been on the market for years. Over the past few years, AstraZeneca, the manufacturer for Seroquel, began marketing this drug to help treat post-traumatic stress disorder (PTSD), insomnia and other conditions not approved by the FDA.
Studies were recently conducted on the side effects of Seoquel. Vanderbuilt University published a study noting that sudden heart failure may be a new side effect. The FDA and AstraZeneca are both reviewing this study to determine its accuracy.
In October of 2009, AstraZeneca paid out $520 million dollars as part of settlement agreements for two federal investigations over clinical trials and off-label promotion, and two whistle-blower lawsuits over aggressive sales and marketing. Details of the federal investigations and whistle-blower lawsuits were not made public. This $520 million barely made a dent in this multi-billion dollar drug, with sales since 2004 totaling over $17 billion.
One of Seroquel’s most recent uses has been for treatment of post-traumatic stress disorder in American soldiers, claiming the drug helps alleviate symptoms of insomnia and restlessness. Thousands of soldiers have been treated for this disorder with Seroquel over the last nine years.
The Associated Press reported on one soldier, Andrew White, who was prescribed the drug after a nine month tour in Iraq after showing signs for PTSD. As his nightmares continued, his dosages of Seroquel were increased over time, and he was taking more than double the maximum dose prescribed to those using it for schizophrenia.
Not long after started this increased dosage, White died in his sleep. There have been atleast a half-dozen deaths among soldiers taking this drug to treat PTSD, but that number is likely grossly understated.
This story raises a much bigger issue. Psychiatrists are allowed to prescribe this drug off-label, which means they can prescribe this drug for unapproved indication. Off-label prescriptions tend to be common place in today’s pharmaceutical-driven society, especially since the FDA procedures to approve a drug are costly and time-consuming.
There is generally substantial literature to support off-label usage, which is what doctors will use to determine whether to prescribe these drugs. Doctors have the ability to issue any drug for an unapproved reason, as long as they use their professional judgment to deem it safe and effective for the condition they are prescribing it for.
Isn’t it time that the FDA crack down on the off-label use of drugs as the risks seem to outweigh any potential benefit?
For more information on the Seroquel case, read the Associated Press article: http://www.google.com/hostednews/ap/article/ALeqM5iPPHBQ6w28w4kTXzANGm6kCzPN1gD9HTRUQ80
For more information on Off-Label Prescriptions, read this article by the American College of Physicians: http://www.annals.org/content/145/4/305.full?etoc
If you or anyone you know has been adversely affected by using Seroquel, contact Gersowitz Libo & Korek, P.C. at 800-529-9997
Spotlight on Potentially Dangerous Prescription Drugs – Avandia
Prescription drugs with unhealthy, dangerous, and potentially deadly side-effects are a persistent cause of debilitating injury to Americans. The Food and Drug Administration (FDA) is the lead governmental agency tasked with overseeing issues of drug safety, and in instances of immediate danger it is empowered to issue recall orders for products deemed harmful. In February 2010, following years of scientific studies, the FDA was formally petitioned for a ban and recall of the prescription drug Avandia.
Avandia by GlaxoSmithKline
Avandia is a commonly prescribed drug that is intended to assist those with Type-2 Diabetes gain control of their blood glucose levels. It was first released by GlaxoSmithKline in 1999, and is known generically as thiazoliodinedione. Initial data regarding side-effects from the use of Avandia noted the potential for the following fatal side-effects:
- Heart attack [interruption of blood supply to the heart]
- Congestive heart failure [insufficient or failed cardiac output]
- Stroke [interruption of blood supply to the brain]
- Pulmonary embolism [blood clotting within the lungs]
Additional side-effects, of an immediately non-fatal though damaging nature, are:
- Bone fractures, particularly in the extremities
- Pulmonary hypertension [excessive blood pressure within the lungs]
Several patient factors were found to contribute to elevated risk, including history of heart attack, heart disease, liver disorders, stroke, congestive heart failure, diabetes-related vision problems, and/or high blood pressure/hypertension. Increased incidence of hypoglycemia (dangerously low blood sugar) was noted in Avandia patients that were also taking birth control pills, diuretics, asthma medications, steroids, anti-convulsant drugs, and/or thyroid medications.
Historic FDA Warnings Regarding Avandia
Reports of these side-effects have provoked numerous lawsuits, as well as action by the FDA to warn consumers of the potential for harm resulting from the use of Avandia. In 2007, the FDA issued a national alert to health professionals and the public at large warning of these side-effects. The FDA also required GlaxoSmithKline to include so-called ‘black box’ warnings on Avandia labels. Black box warnings are the most serious advisories required by the FDA, and are reserved for warnings about the potential for immediately fatal drug side-effects.
Clinical Evidence of Fatal Side-Effects Resulting from the Use of Avandia
In September 2007, the Cleveland Clinic released the long-awaited results of their study of the side-effects of Avandia, which noted the following conclusions regarding Avandia patients:
- 43% increased likelihood of heart attack
- 50% increased likelihood of congestive heart failure
- 64% increased likelihood of sudden cardiac death
Compensation for Patients Who Have Suffered from Avandia Side-Effects and Complications
Avandia is currently under review by the FDA for a potential recall announcement. Despite the fact that a recall has not yet been announced, the evidence for both fatal and non-fatal side-effects resulting from the use of Avandia is abundant.
If you or your loved ones have been injured as a result of taking Avandia, you may be entitled to compensation. Contact Gersowitz Libo & Korek, P.C. for a free consultation in order to explore your full legal rights. We are experienced litigators in the field of drug injury & liability, and our team of skilled attorneys has the experience, knowledge, and determination to ensure that you receive the full recompense that you are legally entitled to.