Defective Drugs
Before marketing products to the public, it is imperative that pharmaceutical companies ensure the safety and efficacy of these products. Failure to do so jeopardizes the health of countless unknowing consumers.
As a patient, you trust the opinion of your healthcare provider(s), and rely on drug makers to provide safe and effective products. When pharmaceutical companies put unsafe or untested drugs on the market, this action can affect the health of countless people.
At LaBovick & LaBovick, P.A., our attorneys are experienced and know how to handle pharmaceutical liability claims. We have provided a list of several drugs known or suspected to cause serious health problems. Please be advised that this content is not legal advice, rather it is consumer related drug safety information.
Gadolinium-Induced NSF/NFD
The use of gadolinium as a contrast agent has been linked to the development
of Nephrogenic Systemic Fibrosis and/or Nephrogenic Fibrosing Dermopathy (NSF/NFD).
People with kidney disease or dysfunction are especially susceptible to suffer
serious illness or death from medical treatment involving the use of gadolinium.
The makers of gadolinium-based contrast agents initially failed to provide appropriate warning to doctors and patients regarding the potentially deadly side effects associated with use of the agents. As a result, you may be entitled to receive compensation based on your gadolinium-induced illness, including NSF/NFD.
Additional Information (click to slide open)
Gadolinium’s Use
Patients undergoing magnetic resonance imaging (MRI) or magnetic resonance
angiography (MRA) procedures are given gadolinium as a contrast agent. The
gadolinium, injected into the patient’s veins, accumulates in and around
abnormal tissue, allowing doctors to gather supplementary diagnostic data
during the MRI or MRA procedures. Although the accumulation of gadolinium
around aberrant cell growths or tumors helps doctors treat and diagnose their
patients, its buildup can also lead to serious side effects or even death
under certain circumstance.
Side Effects
Gadolinium’s side effects were initially recognized in 1997. In 2006,
the use of gadolinium as a contrast agent was linked to the development of
Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy (NSF/NFD)
in certain patients. Symptoms of NSF/NFD include:
- Trouble Breathing
- Restricted Movement
- Hardening or Thickening of the Skin
- Organ Paralysis
- Death
Patients with impaired kidney function were proven to suffer the majority
of the adverse side effects from exposure to gadolinium. Because the impaired
kidneys of these patients are unable to remove waste from the bloodstream
sufficiently, toxic reactions to Gadolinium have occurred.
The U.S. Food & Drug Administration (FDA) has approved multiple gadolinium-based
contrast agents for medical use, including:
- Magnevist (Made by Bayer Healthcare)
- MultiHance (Made by Bracco)
- Omniscan (Made by GE Healthcare)
- OptiMARK (Made by Mallinckrodt)
- ProHance (Made by Bracco)
Although the FDA approved these gadolinium-based contrast agents, their makers initially failed to provide patients and doctors with an adequate warning about their potentially deadly side effects -- especially for patients with kidney disease or dysfunction. As a result, in 2007, the FDA ordered these manufacturers to include warning labels in or on the product’s packaging that describes the potential hazards related to their use.
Due to the possible link between gadolinium-based contrast agents and NSF/NFD, patients who have been diagnosed with either of these ailments should contact an attorney immediately. Because doctors and patients were not made fully aware of the potentially deadly side effects of gadolinium-based contrast agents, you may be entitled to receive compensation based on your illness or injuries. Lawsuits are currently being pursued throughout the United States that relate to death and/or illness from gadolinium use.
Yasmin/YAZ Side Effects
In October 2008, the U.S. Food & Drug Administration (FDA) issued a warning
letter to Bayer HealthCare Pharmaceuticals, Inc. (Bayer) concerning the oral
contraceptive YAZ. According to the FDA, Bayer’s advertising and marketing
campaigns of YAZ downplayed the drug’s serious side effects, including
blood clots, stroke, heart attack, deep vein thrombosis, and more.
As a result, claims of YAZ-induced health problems are prevalent, and more than
100 lawsuits have been filed against Bayer in conjunction with using the birth
control.
Additional Information (click to slide open)
Berlex Laboratories first introduced Yasmin, an oral birth control contraceptive, to the market in 2001. When Bayer HealthCare Pharmaceuticals, Inc. (Bayer) bought Berlex Laboratories in 2006, Yasmin became more commonly known and marketed as YAZ.
Due in part to Bayer's successful advertising and marketing campaigns, YAZ achieved more than $600 million in sales by 2007. According to the U.S. Food & Drug Administration (FDA), however, these campaigns downplayed the serious risk factors involved with taking the oral contraceptive. The FDA warned the makers of YAZ in 2003 and 2008 about potentially misleading statements in their advertising regarding the product.
In October 2008, the FDA sent a letter to Bayer citing the numerous ways in which the advertisements of YAZ minimized the risks associated with taking the oral contraceptive, including exaggerating the drug's usefulness.
The FDA asserted that the manufacturer seemed to downplay the serious side effects potentially associated with the use of YAZ in the advertisements. In addition, the ads were found to exaggerate the perceived notion that YAZ could be used to treat severe acne as well as Premenstrual Syndrome (PMS), when in reality it is only approved for the treatment of Premenstrual Dysphoric Disorder (PMDD).
The FDA warning letter prompted 27 states to take legal action against Bayer for deceptively advertising the approved uses of YAZ. As a result, Bayer was forced to change their existing ads, and launch a new advertising campaign that corrected the previously misleading or false pretexts about the oral contraceptive.
Yasmin/YAZ Side Effects
Although these precautions offered clarity to the approved uses of YAZ, they
unfortunately came too late for some women. YAZ users have reportedly experienced
serious side effects from using the oral contraceptive, including:
- Blood Clots
- High Blood Pressure
- Heart Attack
- Stroke
- Deep Vein Thrombosis
- Pulmonary Embolism
- Kidney Damage
- Sudden Death
Although women with risk factors such as high blood pressure, cardiovascular problems, or diabetes are more likely to experience these serious side effects, such symptoms have also occurred in young, healthy women who use YAZ. Drospirenone, a synthetic progestin used in the manufacturing of the contraceptive, is believed to be the cause of these serious health risks.
Due to the understated health risks associated with the use of YAZ, more than 100 lawsuits have been filed against the contraceptive's manufacturer. These suits come from women who sustained injuries including heart attacks, blood clots, strokes, and pulmonary embolisms from taking YAZ. The birth control has also been linked to the death of many young women.
If you or a loved one took YAZ as a result of Bayer's marketing campaign, and suffered from a blood clot, heart attack, stroke, or other serious injuries, please call 1-888-777-3884 or fill out the Contact Us form at the right side of this page. Our Personal Injury attorneys have the experience to protect the rights of those injured as the result of taking defective drugs such as YAZ. Let us fight for you.
Hydroxycut Side Effects
The use of Hydroxycut products is linked to nearly 30 serious injuries, and
at least one (1) death. As a result, the FDA has banned more than a dozen Hydroxycut
products from the market. Health risks include severe liver damage (sometimes
requiring patients to undergo a liver transplant), cardiovascular disorders,
and more.
Additional Information (click to slide open)
The Health Risks of Hydroxycut Products In an effort to lose weight, attain a healthier lifestyle, and build muscle many people used Hydroxycut's dietary supplement products to help achieve these goals. Made by Iovate Health Sciences, Inc. of Oakville, Ontario and distributed in the United States by Iovate Health Sciences U.S.A., Inc. of Blasdell, NY, Hydroxycut's products were marketed as supplements that could facilitate substantial weight loss by burning fat as well as increasing energy. Because of these and other reasons, everyone from body builders to dieters used Hydroxycut unsuspectingly.
However, these dietary supplements proved to have a variety of serious side effects including liver damage and cardiovascular disorders. The U.S. Food & Drug Administration (FDA) received more than 23 reports of injuries stemming from the use of Hydroxycut products. In some cases, the damage was so severe that a liver transplant was necessary. In addition, at least on death can be attributed to use of the dietary supplements. As a result, the FDA issued a recall for more than a dozen Hydroxycut products beginning on May 1, 2009.
Hydroxycut Products Recalled by the FDA
According to the FDA's Web site, the banned Hydroxycut products include:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Caplets
- Hydroxycut Max Liquid Caplets
- Hydroxycut Regular Drink Packets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Natural
The FDA indicates that although serious problems associated with taking Hydroxycut products is rare, "anyone taking Hydroxycut products could be at risk. For this reason, [the] FDA recommends that all people stop using Hydroxycut weight loss products."
The unfortunate reality is that many innocent people have to suffer before a product's dangerous side effects can be determined. The users of Hydroxycut simply wanted to improve their health by using so-called natural, safe, and effective dietary supplements. Instead, many Hydroxycut users may have unknowingly put their health at risk.
Hydroxycut's Serious Health Effects
Hydroxycut-related injuries and/or illnesses include:
- Liver Damage resulting from Hydroxycut use
- Symptoms of Liver Damage include:
- Brown Urine
- Jaundice
- Nausea and Vomiting
- Loss of Appetite
- Excessive Weakness and Fatigue
- Symptoms of Liver Damage include:
- Seizures
- Cardiovascular Disorders
- Muscle Damage leading to Kidney Failure
If you have suffered liver damage or another serious health problem from using Hydroxycut, please contact an experience pharmaceutical lawyer immediately. As a Hydroxycut-related injury victim, you may be entitled to receive compensation for your medical bills, pain and suffering, and more.
Our attorneys have the knowledge and skills to provide injured individuals with the expert legal counsel and guidance they need to win. At LaBovick & LaBovick, P.A., we specialize in protecting the rights of injury victims. To discuss your case, please call 1-888-777-3884 or fill out the Contact Us form at the right of this page.
Spiriva HandiHaler Side Effects
In 2008, the FDA issued a review concerning the safety of Spiriva’s HandiHaler.
This review came after reports that users of the widely prescribed inhaler are
at an increased risk of serious health problems. These include the elevated
risk of stroke or heart attack.
The HandiHaler is prescribed to patients suffering from chronic obstructive pulmonary disease (COPD), one of the most common causes of death in the United States. Although the FDA recommends that patients should not stop using Spiriva without first consulting their physician, the agency also states that there are increased risks associated with the use of Spiriva’s HandiHaler.
Additional Information (click to slide open)
The Potential Side Effects of using Spiriva HandiHaler
The Spiriva HandiHaler, manufactured by German pharmaceutical giant Boehringer
Ingelheim Pharma KG and distributed in the United States by Boehringer Ingelheim
Pharmaceuticals, Inc., of Ridgefield, CT, is currently under review by the
U.S. Food & Drug Administration (FDA). This review, issued by the FDA in 2008,
comes after reports that users of the inhaler have an increased risk of serious
health problems, including stroke or heart attack.
In compliance with the FDA's review, Boehringer disclosed data to the FDA that compares patients using placebo inhalers and patients using the actual HandiHalers. According to these comparisons, patients using the Spiriva HandiHaler suffered more strokes and other serious complications than patients using placebo inhalers.
Jointly marketed in the U.S. by Boehringer and Pfizer, Inc., the Spiriva HandiHaler is used to treat patients with chronic obstructive pulmonary disease (COPD). As one of the most common causes of death in the United States, COPD is a serious disease that affects millions of Americans. It is important to note that the FDA had approved the use of Spiriva's HandiHaler to treat patients with COPD.
Spiriva HandiHaler Use and the Risk of Stroke
A warning regarding the potential risk of stroke in connection with the use
of Spiriva's HandiHaler was released in 2008 by the FDA. According to documents
provided by the inhaler's manufacturer, Boehringer, patients using the HandiHaler
suffered strokes at a rate of two (2) out of 1,000. The FDA, however, urged
Spiriva users not to be alarmed by this data, and to seek the opinion of their
doctor involving their use of the inhaler.
Due to Spiriva's relatively effective treatment of COPD, it is still widely used by patients to treat this disorder. The FDA indicates that although there is a risk of stroke associated with using the inhaler, that patients should not stop using the HandiHaler without first consulting their doctor.
Spiriva HandiHaler Use and the Risk of Heart Attack
A research article published in the Journal of the American Medical Association
entitled "Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular
Events in Patients with Chronic Obstructive Pulmonary Disease" highlights
the potential cardiovascular dangers associated with using the HandiHaler.
The article, written by Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg,
MD discusses the HandiHaler's use by patients and the potential increase in
risk of heart attack, cardiac death, or stroke.
Previous studies show that tiotropium (an agent in the HandiHaler) and ipratropium (an agent in Atrovent) have adverse effects on patients, but that neither are linked to cardiac health. Therefore, it is important to note that Spiriva is not specifically known to affect the heart and/or cardiovascular system. More research must be done before a concrete link is determined between the risk of heart attack or related ailments and the use of the HandiHaler. Nonetheless, the FDA determined that there are increased risks associated with the use of Spiriva's HandiHaler.
Spiriva HandiHaler and Your Health
Before marketing products such as the HandiHaler to the public, it is imperative
that pharmaceutical companies ensure the safety and efficacy of these products.
Failure to do so not only means the potential for a recall, but also that
the lives of countless unknowing consumers are jeopardized. If you or a loved
one suffered a stroke or other ailments in association with the use of Spiriva's
HandiHaler, contact a lawyer immediately.
The attorneys of LaBovick & LaBovick, P.A. have extensive experience and knowledge in the field of pharmaceutical law. Since 1992, our Personal Injury Division lawyers have represented individuals and their families who have been injured or become ill as the result of negligence. Our firm has the expertise, ability, and resources to get the compensation our clients may be entitled to receive. To discuss your case, call Toll Free 1-888-777-3884 or fill out the Contact Us form at the right side of this page.
Although the content on this site is informative, it is not legal advice. Please be advised that the purpose of this site is to provide information about defective drugs and to educate consumers about the potentially lethal side effects they may cause. If you wish to discuss a potential claim regarding a defective drug, please feel free to call 1-888-777-3884 or fill out the Contact Us form at the right side of this page.
Our Personal Injury Division is comprised of experienced and aggressive attorneys
who specialize in the area of defective drug claims. The lawyers of LaBovick
& LaBovick, P.A. have been helping injured victims and their loved ones
get the justice they deserve since 1992. We will work hard to ensure that victims
get the settlement they may be entitled to receive from the responsible party.
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