Update: First AndroGel Bellwether Ends in Mistrial
June 19, 2017 – The first attempt to hold AbbVie Inc. responsible for the side effects alleged from AndroGel has ended in a mistrial after the lead plaintiff’s attorney suffered from heart problems. Court documents indicate that the man was hospitalized with heart complications on June 10 and underwent an unspecified procedure, but has since been released and is now recovering back home.
What is Low Testosterone?
Low testosterone (also called ‘Low T’), is a common medical condition known as hypogonadism. Low T occurs when a man’s testosterone levels have fallen below about 300 ng/dL. T levels between 300 ng/dL and 1000 ng/dL are considered to be normal. The brain and testes work together to keep testosterone within this range. When T levels dip below this range, the brain signals the testes to make more. When there is enough testosterone, the brain tells the testes to make less.
AndroGel Stroke Risk
Although AbbVie, Inc., the company that makes AndroGel, knew – or should have known – that certain users may face a risk of stroke from AndroGel, information has been withheld from the public and medical communities. In 2009, a study funded by the National Institutes of Health (NIH) involving 200 older men with a history of heart disease was halted prematurely due to a spike in heart attacks among testosterone users.
Concerns about the AndroGel stroke risk were further increased in November 2013, when a study published in the Journal of the American Medical Association (JAMA) determined that men who underwent a coronary angiography had a 29% higher rate of stroke, heart attack, and sudden death when they were treated with AndroGel or other TRT supplements.
Then in January 2014, a study published in PLOS ONE found that testosterone boosters like AndroGel double the risk of heart attack in men over 65. For younger men with a history of heart disease, the researchers found that the heart attack risk may be nearly tripled.
Yet despite mounting evidence about the risk of AndroGel stroke and heart attack, AbbVie placed its desire for profits ahead of public safety by continuing to aggressively market the product without providing accurate and adequate warnings.
How Do Strokes Occur?
A stroke or ‘brain attack’ occurs when a blood clot blocks an artery, or a blood vessel breaks, interrupting blood flow to a region of the brain. When either of these things happen, brain cells die and brain damage ensues. When brain cells die, abilities controlled by that part of the brain are lost. These abilities typically include speech, movement and memory. How a patient is affected depends on where the stroke occurs in the brain and how much of the organ has been damaged.
For example, a patient who has suffered a small stroke may experience only minor complications such as weakness in the arms or legs. Larger strokes, however, may cause patients to become paralyzed on 1 side or lose their ability to speak. Some people recover completely from strokes, but more than 2/3 of survivors will have some form of lifelong disability.
How is a Stroke Diagnosed?
Medical History and Physical Exam – The doctor will ask the patient or one of their family members about their personal risk factors. Examples may include high blood pressure, cigarette smoking, heart disease, or use of testosterone replacement therapy (TRT) supplements like AndroGel. The doctor will also ask about when onset of the initial symptoms began. During the physical examination, the doctor will perform tests to determine the patient’s mental alertness, coordination and balance. The doctor will then check for numbness in the face, arms, and legs; confusion, trouble speaking and vision problems. He or she will look for symptoms of carotid artery disease, a common cause of ischemic stroke.
The following procedures may be ordered to confirm the diagnosis of an AndroGel Stroke:
- Brain Computed Tomography (CT Scan) – Test that uses x-rays to take detailed pictures of the brain. CT scans are often performed immediately after a stroke is diagnosed. These tests can reveal bleeding in the brain or damage to brain cells resulting from an AndroGel stroke. CT scans can also identify other conditions in the brain that may be causing symptoms.
- Magnetic Resonance Imaging (MRI) – Uses magnets and radio waves to form pictures of the body’s organs. MRIs can reveal abnormalities in brain tissue and damage to brain cells caused by a stroke.
- Computed Tomography Arteriogram (CTA) & Magnetic Resonance Arteriogram (MRA) – Tests used to show the large blood vessels in the brain. CTAs & MRAs can give the medical team additional data about the location of a blood clot and blood flow in the brain.
- Carotid Ultrasound – Test that uses sound waves to make pictures of the carotid arteries. These arteries supply oxygenated (red) blood to your brain. Ultrasound tests can reveal whether plaque has narrowed or obstructed the carotid arteries.
- Carotid Angiography – Test that uses dye and x-ray pictures to show the carotid arteries. For this test, a catheter is inserted into an artery (usually in the groin), then moved up into a carotid artery. The doctor then injects a contrast dye which helps make the artery visible on x-ray photos.
- Electrocardiogram (EKG) – Test that measures the electrical activity of the heart. EKGs reveal how fast the heart is beating and its rhythm. The test also monitors the strength and timing of electrical signals as they pass through the heart. An EKG can help diagnose heart problems that may have caused the stroke.
- Echocardiography (Echo Test) – Uses sound waves to make pictures of the heart. Echo tests provide data about the size and shape of the heart, and how well its chambers and valves are working. This test can also reveal blood clots inside the heart and problems with the aorta.
- Blood Tests – A blood glucose test can determine the amount of sugar in the patient’s bloodstream. Low blood glucose levels may cause symptoms that mimic those of a stroke. A platelet count measures the number of platelets in the blood. Blood platelets are cell fragments that assist in the clotting process. Abnormal platelet levels may be an indicator of a bleeding disorder (not enough clotting) or a thrombotic disorder (too much clotting).
How Can AndroGel Cause a Stroke?
In November 2013, a study published in the Journal of the American Medical Association (JAMA) looked at 8,709 older men who were assessed for heart problems, and found that those who used prescription testosterone boosters were 30% more likely to experience a severe cardiovascular episode – a stroke, heart attack or death.
“Our findings raise some uncertainty regarding the potential safety of testosterone use in men,” said the researchers. While testosterone users should not quit taking the supplements without talking to their doctor first, the study’s authors added, “it is important to inform patients that long-term risks are unknown and there is a possibility that testosterone therapy might be harmful.”
The JAMA study is at least the 2nd major study to be published in recent years suggesting there may be severe health risks associated with Low T treatments. In 2010, a clinical trial was halted prematurely after a number of test subjects who had been treated with testosterone began having heart attacks and strokes.
Today, nearly 3% of American men over the age of 40 take prescription testosterone supplements. Driven in large part by direct-to-consumer marketing campaigns, annual prescriptions for testosterone boosters increased 5-fold from 2000 to 2011. The market for these products is now a nearly $2 billion annual industry.
Most men probably never paid attention when the surge of women on hormone replacement therapy came to an abrupt halt in the early 2000s, after studies linked the drugs to increased rates of breast cancer and stroke. Now, a growing number of scientists are concerned that the massive popularity of testosterone replacement therapy (TRT) – which is basically a type of hormone replacement for men – may also have similar health consequences.
In the JAMA study, the 14% of men who began taking testosterone supplements after undergoing angiography were typically younger and healthier than the 86% who were not on TRT. However, when all the test subjects were followed for an average of 3 years, those who used testosterone boosters were nearly 30% more likely than those who did not to have a stroke, heart attack or die from any cause.
In the 3 year period they were followed, more than one-quarter of the testosterone users had a stroke, heart attack or died. Among non-users, less than 20% experienced one of those outcomes. Notably, among patients who were treated with testosterone supplements, those who entered the study with unobstructed coronary arteries were just as likely to suffer one of those outcomes as were those with pre-existing coronary artery disease (CAD).
“In light of the high volume of prescriptions and aggressive marketing by testosterone manufacturers, prescribers and patients should be wary,” warned physician and epidemiologist Anne R. Cappola. “There is mounting evidence of significant cardiovascular risk,” which highlights the need for additional studies into the TRT phenomenon.
Recent medical advances have produced a whole new range of options to draw from when tailoring treatment for stroke victims. In the acute phase, AndroGel strokes can be treated with prescription medications that help limit brain damage. So-called “clot-busters” are most effective when administered within 3 hours of a thrombotic or an embolic stroke. There also are number of new treatment options coming in the near future: Clinical trials are now underway on several medications that can potentially protect brain tissues after a stroke. Additionally, preliminary studies with devices that chill the brain have determined that inducing hypothermia may reduce the damage caused by a stroke.
Physicians also have the benefit of drugs that can prevent strokes in high-risk patients, especially those who have had transient ischemic attacks (TIAs), also known as mini-strokes. These include anticoagulants like heparin or warfarin, as well as antiplatelet agents such as aspirin, dipyridamole and clopidogrel.
Interventional operations can help individuals with conditions that are either caused by or lead to strokes. In years past, surgeons clipped aneurysms to stop bleeding. However, in recent years, a number of techniques have been developed including introducing coils into the aneurysms, which can prevent bleeding without the risks that come with brain surgery.
Treatment of Ischemic Stroke
Ischemic stroke treatment is designed to dissolve and remove blood clots that are preventing blood from reaching the brain. The most common ischemic stroke treatments include:
- Intravenous Tissue Plasminogen Activator (tPA) – First line of treatment against ischemic stroke. tPAs are injected into the blood and designed to seek out clots that are causing a stroke. Once there, the medication breaks the clot up until blood flow has been restored.
- Intra-Arterial Thrombolysis – Stroke treatment that can be administered for up to six hours after the onset of initial symptoms. Intra-Arterial Thrombolysis consists of tPA being injected directly into the clot that caused the stroke. To accomplish this, a catheter is inserted into 1 of the blood vessels in the leg, and is guided to the brain with a video system. Once the clot is located, the catheter passes into it, and the injection is administered. The tPA then dissolves the clot until blood can flow to the area of the brain where the stroke occurred. Unfortunately, because this treatment requires highly specialized equipment and advanced technical expertise, its availability is limited to a few hospitals around the country.
- Mechanical Embolus Retrieval in Cerebral Ischemia (MERCI retriever) – New approach that removes or breaks up clots that have migrated into a small blood vessel. This is done by passing a device from a blood vessel in the leg all the way into the brain where the clot is lodged. MERCI then captures the clot and retrieves it from the body, restoring blood flow to the affected area.
Hemorrhagic Stroke Treatment
The treatment of hemorrhagic strokes are intended to stop internal bleeding, and to remove blood that might cause swelling or pressure on the brain. The 2 most common causes of hemorrhagic stroke and their treatments include:
- Ruptured Aneurysm – Aneurysms are weak areas in the wall of a blood vessel that protrude out until they break. In most cases, aneurysms rupture due to high blood pressure. Broken aneurysms require brain surgery to fix the damaged blood vessels.
- Abnormal Brain Blood Vessels – Vessels connected to one another in such a way that causes them to bleed into the brain. When this occurs, surgery is required to remove the abnormal blood vessels.
The brain is an amazing organ. When blood flow to part of the brain is blocked, alternate pathways can be made to reroute blood to the damaged region. The brain also has the ability to make compensations. When needed, 1 area can take over functions that were previously controlled by another area.
Fortunately, AndroGel users who have minor strokes may be able to recover from most disabilities. Others who suffer massive strokes may be left with permanent disabilities, but still may be able to lead productive lives afterward.
Stroke rehabilitation should begin as soon as possible after a patient returns from the hospital. The 1st priority is to stabilize the condition and eliminate any potentially life-threatening complications. Doctors will take steps to prevent another stroke and limit any long-term side effects. Once these steps have been taken, stroke recovery can begin. The sooner the patient starts the rehabilitation process, the more likely they are to regain lost abilities and skills.
Stroke Recovery Steps
In most patients, stroke recovery takes place in phases, over a period of months and years. However, each stroke is different and the extent of damage varies greatly from patient to patient. Below are the general phases stroke patients go through during the recovery process:
- Treatment – Should begin when a stroke patient is first admitted to the hospital. Doctors will diagnose the specific type of stroke, and provide the recommended treatment. This may consist of clot-busting medications, tissue plasminogen activator (tPA), blood thinners, or surgery to fix a broken blood vessel. Treatment is centered around preventing another stroke and limiting brain damage.
- Recovery – After a stroke, a certain amount of spontaneous recovery occurs in most patients. Abilities that were briefly lost will return again. This process typically takes place over the first few weeks, and then begins to taper off. Despite what doctors predict, the vast majority of stroke victims regain more than expected. Doctors are required to give the worst case scenario.
- Rehabilitation – Typically begins while the patient is still in the hospital. A recovery team will work with the patient to try to bring back lost abilities. This can be extremely frustrating for the patient, as they realize their new limitations after a stroke. In most cases, this is when anger and depression sets in. However, stroke patients should keep in mind that with proper therapy, most skills can be relearned.
- Returning Home – This is an exciting time, but adjustments may have to be made, some temporary and some permanent. For the patient, simple tasks such as tying shoes or putting on their clothes can be a challenge. Velcro shoes and drawstring pants can be worn to make this process easier. Other problems may not be as easy to solve. It takes time and courage, but family, friends and medical experts will be there to ease the transition.
Do I Have an AndroGel Stroke Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AndroGel Lawsuits. We are handling individual litigation nationwide and currently accepting new stroke cases in all 50 states.
Again, if you had a stroke after taking AndroGel, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.