Drug companies may release a drug for patient use which has not been adequately tested or may cause unforeseen side affects. The following are examples of drugs that have recently been found to cause side effects, such as heart attacks, strokes or even death:
If you or a loved one suffers an injury after taking a drug, it is highly recommended that you seek the advice of experienced legal counsel to determine your options and to preserve your rights.
Actos
Actos, like the popular drug Avandia, is prescribed for adults with Type-2 diabetes and works to maintain proper levels of sugar. Actos prevents the liver from producing more sugar than is necessary and allows more efficient use of the insulin that is produced by the body.
Complaints of cardiovascular problems, fragile bones and serious eyesight conditions have been surfacing for years by Actos users. A 2007 study which compared the health risks of people taking Actos with the popular drug Avandia concluded that the side effects associated with Avandia (primarily heart failure, cardiovascular disease and stroke) did not appear to be a concern with Actos. In fact, Actos has often been prescribed as an alternative to Avandia.
However, in June 2011, evidence emerged from the FDA’s own safety review and a study conducted in France supporting a link between Actos and bladder cancer. This prompted the FDA to release a safety warning informing the public that use of Actos for more than one year “may be associated with an increased risk of bladder cancer.” This warning resulted in the manufacturer, Takeda Pharmaceuticals, revising its warning label to add an increased risk of bladder cancer to the list of side effects associated with Actos. The new label also now advises doctors to refrain from prescribing the drug to patients with bladder cancer and cautions the use of Actos on patients with a history of bladder cancer. In France and Germany, the evidence of a link between the drug and bladder cancer prompted a recall and a ban in both countries.
If you are taking Actos, you should be aware of the following symptoms of bladder cancer: blood in the urine; frequent urge to urinate a small amount of urine; pain and burning when urinating; pain in the lower back; pain in the bones; and blood in mucus when coughing.
Duragesic
The Duragesic (also known as the fentanyl transdermal system) patch is used by patients with moderate to severe chronic pain, who have been taking a regular narcotic pain medicine for longer than a week. Each patch contains a three day dose of fentanyl gel which is designed to release a steady dose of the analgesic through a rate controlled membrane. Patients must avoid exposing the patch to excessive heat because this exposure promotes the release of fentanyl from the patch. This increases the absorption of fentanyl through the skin, which can result in nausea, sedation, drowsiness, or a fatal overdose. The FDA issued an alert regarding the use of Duragesic on July 15, 2005, which was updated in December 21, 2007. As recently as June 2007, a Florida family was awarded $5.5 million dollars in the wrongful death verdict of a 28 year old man following the first United States Duragesic patch trial.
Gadolinium
Gadolinium is a highly toxic iodine-based contrast agent used in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) to make the results of these tests more visible and more easily interpreted. After the test is administered, gadolinium is removed from your body by your kidneys. However, if a patient’s kidneys are not functioning properly, gadolinium remains in the body and has been known to cause serious harm.
Gadolinium has been linked to nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD), an extremely serious condition which involves hardening of the skin, resulting in immobility, damage to internal organs and sometimes death. NSF/NFD cannot be treated and can be very painful and debilitating.
Symptoms of NSF/NFD include tightening or thickening of the skin; “woody” skin; red or dark patches of skin; burning, itching and/or sharp pains in affected areas; fluctuating hypertension; symmetrical skin lesions, most commonly on the ankles and thighs and between the wrists and upper arms; muscle weakness; deep bone pain in the hips and ribs; and yellow plaque around the eyes. A diagnosis of NSF/NFD can only be made through a skin biopsy.
Heparin
Heparin is a blood-thinning drug manufactured by Baxter and frequently used in surgery and dialysis. Heparin contains an active pharmaceutical ingredient (API) from China that has been found to be contaminated. The drug has been known to cause allergic or hypersensitive reactions, with symptoms such as low blood pressure, angioedema, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.
In January 2008, Baxter recalled 9 lots of its 1000/unit mL multi-dose Heparin vials after the company received 100 reports of serious allergic reactions in patients who had been administered Heparin. Following the recall, Baxter said that it was suspending the manufacture of Heparin until the reason behind the reactions could be determined.
In mid-February 2008, the FDA issued a Public Health Advisory warning doctors and other health practitioners not to use Baxter Heparin products. According to the FDA, since the beginning of 2008, it has received 350 reports of side effects linked to Baxter Heparin. The FDA also reported that four patients had died after being administered the drug.
On March 5, 2008, both Baxter and the FDA announced that their respective investigations had found a contaminant in the active ingredient used in Heparin.
Raptiva
A serious and potentially fatal brain infection known as progressive multifocal leukoencephalopathy (PML) has been associated with the psoriasis drug Raptiva. This drug has been the subject of both a black box warning in 2008 and a Public Health Advisory issued by the FDA in 2009. Raptiva was finally withdrawn from the market by its manufacturer in April 2009, after three people died from PML.
Reglan
Reglan (also known as metoclopramide) is used as a short-term treatment of gastroesophageal reflux disease and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines), as it increases the rate at which the stomach empties into the intestines. Reglan has been linked to tardive dyskinesia, which can include involuntary and repetitive movements of the body, such as lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. Often these symptoms are irreversible once they manifest themselves. On February 26, 2009, the FDA imposed a warning regarding the long-term or high-dose use of Reglan.
Yasmin/Yaz
Yaz and Yasmin are two popular oral contraceptives manufactured by Bayer Healthcare that use drospirenone and ethinyl estradiol to prevent pregnancy. They are also both used to treat premenstrual dysphoric disorder (PMDD) and moderate acne in women. Yaz was approved by the FDA in 2006 and Yasmin was approved in 2001. Yasmin contains 30 mcg of ethinyl estradiol, while Yaz contains 20 mcg. Yaz is taken by a woman on a 24 day cycle while Yasmin has the traditional 21 day cycle.
Despite their popularity, both Yaz and Yasmin have been linked to serious, life-threatening side effects, including cardiac arrhythmia, kidney failure, seizure, deep vein thrombosis, pulmonary embolism, blood clot, heart attack, stroke and death.
While ethinyl estradiol, the estrogenic compound, has been used in birth control pills since the 1970s, drospirenone, the progestin in both Yaz and Yasmin is new and is considered a “fourth generation” progestin. Although Bayer has claimed that drospirenone is safe when used in combination with estrogen to prevent pregnancy, there is little data to support this. Indeed, studies have only shown drospirenone to be more dangerous than the progestin used in comparable birth control medication.
Drospirenone is a diuretic and may increase potassium in the body and may lead to a condition known as hyperkalemia. Hyperkalemia can cause heart rhythm disturbances and if left untreated, can be fatal. When hyperkalemia disrupts normal heart rhythms, blood flow through the heart can be slowed to the point that blood clots can form. Blood clots in the heart can cause heart attack, stroke or a pulmonary embolism.
Studies have also shown that long term use of diuretics such as drospirenone may cause gall bladder disease such as cholecystitis (gall bladder inflammation) and cholelithiasis (gall stones), and may even necessitate gall bladder removal. Bayer’s product packaging does not contain a warning about the adverse effects of its products on the gall bladder. As a result, many women have developed gall bladder problems while on Yaz or Yasmin.
