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Dangerous Drugs With Some Very Serious Side Effects, Several Lawsuits and Late FDA Warnings

 


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Each day many seriously ill patients struggle to manage their serious health conditions. As a result of the intense need for help with these problems, many new products, ideas for rehabilitation and innovative treatment techniques continue to evolve. Some of these innovations in the form of new medicines lead to problems, some of which we discuss below:

Ketek

Ketek hit the markets in 2004. The drug was a massive success, for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae and for the treatment of other wide variety of bacterial infections. But it wasn't long before serious problems arose. Reports began to surface that linked the use of Ketek, which helped patients treat extreme cases of bacterial infections, with the development of liver failure. In May 2006, the FDA recommended that a black box warning be added to the Ketek label, stating that “severe, life-threatening, and in some cases fatal" liver toxicity has been reported in patients taking the drug. Ketek has been linked to 12 cases of liver failure and four people died from liver complications linked to the drug and lawsuits began to arise as a result and on behalf of seriously injured patients. In some cases, liver damage worsened rapidly and happened after just a few doses of Ketek.

Trasylol

Trasylol was used to reduce blood loss of patients undergoing heart surgery, as it was designed to slow or prevent bleeding. However, after an elaborate study showed that patients who used Trasylol for this purpose faced an increased the risk for serious kidney or heart complications. Ultimately, in September 2007, the FDA issued a statement indicating that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. In a further statement, the FDA outlined that the Health Practitioners who use Trasylol should monitor their patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain. Trasylol use should be limited only to those situations where the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.

Heparin

Heparin is has been used to prevent clotting around the wound created when patients receive Dialysis and also to patients undergoing Heart Surgery. However, the FDA recently announced recalls of several products containing heparin because of their tendency to result in serious, organ-damaging and even life-threatening bacterial infections because of the presence of these bacteria in these products, especially those where Heparin is administered as high bolus shots

Serious adverse events include oral swelling, nausea, vomiting, sweating, shortness of breath, hypotension, and anaphylactic shock. Many symptoms are visible within first few minutes of the drug administration.

Gadolinium

Gadolinium is an element, which is included in contrast agents for those who receive MRI's or MRA's. This helps medical practitioners obtain an accurate read and diagnosis of conditions as a result of these scans because the gadolinium containing contrast agent made it that much easier to read. For years Gadolinium has been used in the enhancement of MRI images on thousands of patients without a large number of serious adverse events occurring. Infact, FDA approved Gadolinium for use in MRI procedures in 1988 and since then they have approved five specific Gadolinium based contrast agents for usage in the imaging procedure. Generally, the side effects associated with the injection of Gadolinium have been mild to moderate. The most common side effects are a mild headache, nausea, and a slight burning sensation at the site of the injection, experience of lightheadedness and low blood pressure. However, the FDA recently warned against the use of gadolinium injection by those with kidney problems, as these patients were unable to expel the substance, and it's long-term presence in the system can lead to serious injuries and even organ failure. The condition is called Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD). Although this condition is rare with only 300 confirmed cases worldwide, it could, in some cases prove to be fatal.

Tequin

The antibiotic drug was used to treat lung, sinus, and urinary infections as well as some *** transmitted diseases. The FDA issued a warning about the drug in February 2006 against the use of the antibiotic Tequin in people with diabetes after reports of problems with high blood sugar and low blood sugar associated with the drug. A report in late March 2006 confirmed that alarming rates of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) were found in patients using Tequin. The comparative study found that Tequin users were four times more likely to develop low blood sugar and 17 times more likely to develop high blood sugar. Symptoms varied between the two conditions, but it was concluded that Tequin use could result in serious blood sugar complications, including seizures and death. Serious concerns about the drug led to its discontinuation in May 2006.

Paxil

Paxil has been used to treat depression, general anxiety disorder, social anxiety, obsessive compulsive disorder, and post traumatic stress disorder. In the past several years, FDA has issued two important warnings regarding Paxil. In December 2005, FDA warned that taking Paxil during the first three months of pregnancy can double the risk of birth defects. Later in May 2006, a study found that Paxil could increase suicidal behavior, particularly in young adults. An earlier British study back in 2003, warned that children who take Paxil are 1.5 to 3.2 times more likely to engage in suicidal thoughts or attempts than those who do not take the drug.

In 2005, GlaxoSmithKline, the manufacturer of Paxil, was cited by FDA for failing to meet certain quality and safety standards. In fall of 2006, Paxil was recalled over concerns that it was missing a key active ingredient. Patients taking Paxil may experience severe withdrawal symptoms including suicidal thoughts, shooting pain, and flu-like symptoms. While, all SSRIs are habit-forming prescription medications, Paxil is considered the most addictive, which means serious injury could result in patients trying to go off Paxil.

Ortho Evra

Ortho Evra was the first birth control patch approved by the FDA in 2001. The contraceptive only needed to be applied once a week, some women prefer it over the daily birth control pill. However, in November 2006 FDA released a statement warning that using Ortho Evra could double a woman's risk of developing a severe blood clot. The patch contains 60% more estrogen than most birth control pills, containing typically 35 micrograms of estrogen. High estrogen levels could significantly increase the risk of developing a blood clot. Compared to Oral contraceptives, which are first processed through the digestive system before hormones enter the blood stream, Ortho Evra patch, similar hormones come straight into the blood stream, which could result in a gush of hormones causing undesirable effects. Additional serious complications include Deep Vein Thrombosis, Pulmonary embolism, Stroke, Heart attack and Death. At least 23 deaths have been linked to Ortho Evra, 17 of which were caused by blood clot complications. Most of the women who have died were young, healthy, and had no history of cardiovascular conditions.

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