With new prescription drugs rolling out of pharmaceutical companies at a record pace, the federal Food and Drug Administration is under a great deal of pressure to reduce the amount of time it takes for a drug to go from the research phase of development to the market. As a result, the FDA has been giving more and more new drugs what is called “fast track” status in an effort to shorten this waiting period.
Just recently, the FDA issued a warning about several drugs prescribed to treat mental disorders, such as Paxil, Prozac, Welbutrin, Zoloft and several other drugs used by millions of Americans in recent years. The FDA warning informed takers of these drugs (a large percentage of which include American children) that they face increased risks of severe depression and suicidal thoughts.
While “fast track” approval of drugs helps pharmaceutical companies meet their business goals and strategies, the increasing number of people who become seriously ill or die from reactions to prescription drugs is cause for alarm. In fact, more than 200,000 people in the United States die each year from adverse reactions to prescription medications. That is more than the number who die from the use of illegal drugs. And the injuries aren’t just sustained from the use of prescription drugs. People are also injured from reactions to common over-the-counter drugs.
At the Brain Injury Law Center, we represent clients who have suffered serious side effects, illnesses, organ failures or deaths of family members and loved ones as a result of the prescribed use of hazardous prescription drugs.
Our attorneys specialize in representing clients who have used prescription drugs such as Accutane, Arava, Baycol, Celebrex, Cytotec, Enbrel, Ephedra, Fen Phen, Lotronex, Meridia, Oxycontin, Prempro, Premarin, Propulsid, Rezulin, Serzone, Thimerosal, Vioxx and many other prescription drugs that present known hazards to the public.
Below are some descriptions of drugs that are linked to dangerous side effects among their users. To learn more about your legal rights and options if you are suffering from these side effects, contact the Brain Injury Law Center today.
- Duragesic Patch
- Fen Phen
Accutane – A retinoid related to vitamin A that is used in the treatment of severe acne, primarily in adolescents. Accutane’s manufacturer, Hoffman-LaRoche, has notified doctors that the drug may cause depression and/or psychosis up to and in some cases including suicide. This action was taken after the FDA notified doctors that they should watch patients for these side effects in 1998.
Arava – an anti-rheumatic drug approved to treat people with rheumatoid arthritis. The drug works to modify the arthritis, not cure it. On March 28, 2002, the consumer advocacy group Public Citizen requested that the FDA immediately recall Arava on the basis of adverse side effects, severe liver toxicity and liver failure. Patients that have been treated with Arava have reported serious liver injuries, including hepatitis, hepatic failure and acute hepatic necrosis.
Baycol – generic name cerivastatin, initially was approved in 1997 as a member of a class of cholesterol lowering drugs that are commonly referred to as “statins.” Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. Bayer Pharmaceutical Division voluntarily withdrew Baycol from the U.S. market because of reports of a sometimes-fatal muscle reaction called rhabdomyolysis. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in patients who used Baycol were reported more frequently than for other approved statins.
Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body. This condition may be fatal, or may be non-fatal but cause kidney failure, liver injury, seizures, joint and muscle pain, and fatigue for the rest of the patient’s life.
Celebrex – generic name, Celecoxib, received FDA approval in December 1998 for the treatment of rheumatoid arthritis and osteoarthritis. A year later, Celebrex was approved as a drug treatment for patients undergoing treatment for intestinal polyps sometimes found in conjunction with a genetic disorder called familial adenomatous polyposis (FAP). Celebrex is a non-steroidal anti-inflammatory drug (NSAID), and is in a class of drugs commonly referred to as a “Cox-2 inhibitor”.
Health concerns have been raised in recent months regarding the use of Celebrex. The American Heart Association, the National Stroke Association and the Arthritis Foundation all have asked Celebrex’ manufacturer, Pharmacia Corp., to test whether Celebrex increases the risk of heart attack and stroke.
Cytotec – generic name Misoprostol, is used to treat ulcers. It also is used to induce labor, however, that is not its approved purpose. In fact, the manufacturer, Searle, has never sought approval for Cytotec to be used in labor induction.
The administration of Cytotec to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when Cytotec was administered in pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy. Cytotec should not be taken by pregnant women to reduce the risk of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDS).
Duragesic Patch – The Duragesic patch is a prescription pain medication, which contains as its active ingredient one of the most potent narcotics on the market—fentanyl. Eighty times more powerful than morphine, fentanyl is used to manage chronic pain that is unresponsive to other medications. The drug is released through the transdermal Duragesic patch in a continuous dose over the course of three-days. Recently, however, there have been numerous reports of fatal fentanyl overdoses and other negative health effects related to the Duragesic patch.
Enbrel – generic name etanercept, is used to treat moderate to severe rheumatoid arthritis pain. Following the drug’s approval in 1998, 30 of an estimated 25,000 patients treated with the drug reported developed serious infections, including sepsis. Six of the patients died within two to sixteen weeks after treatment began.
Ephedra, or Ephedrine, is a drug that was widely used in the manufacture of dietary supplements, in particular, to help with weight control or weight loss. Ephedrine is a stimulant that is used as an ingredient in diet pills, illegal recreational drugs, and legitimate over-the-counter medications to treat congestion and asthma. Ephedrine has a molecular structure similar to amphetamine. Ephedrine can produce the following adverse reactions: heart attack, stroke, tachycardia, paranoid psychosis, depression, convulsions, coma, fever, vomiting, palpitations, hypertension, and respiratory depression.
Fen Phen refers to the use together of fenfluramine and phentermine. Phentermine has also been used in combination with dexfenfluramine (“deafen phen”). Fenfluramine (“fen”) and phentermine (“phen”) are prescription medications that have been approved by the FDA for many years as appetite suppressants for a short-term treatment in the management of obesity. Phentermine was approved in 1959 and fenfluramine in 1973. Dexfenfluramine (Redux) was approved in 1996 for use as an appetite suppressant in the management of obesity. Recently, some physicians have prescribed fenfluramine or dexfenfluramine in combination with phentermine, often for extended periods of time, for use in weight loss programs. Use of drugs in ways other than described in the FDA approved label is called “off label use.” In the case of fen phen and dexfen phen, no studies were presented to the FDA to demonstrate either the effectiveness or safety of the drugs taken in combination.
The Mayo Clinic reported in 1997 that 24 patients developed heart valve disease after taking fen phen. In five patients who underwent valve replacement surgery, the diseased valves were found to have distinctive features similar to those seen in carcinoid syndrome. The cluster of unusual cases of valve disease in fen phen users suggested that there might be an association between fen phen use and valve disease.
Later that year, the FDA issued a public health advisory that described the Mayo findings. The Mayo findings were reported in the August 28th issue of the New England Journal of Medicine, along with an FDA letter to the editor describing additional cases. The FDA has received over 100 reports (including the original 24 Mayo cases) of heart valve disease associated mainly with fen phen. There were also reports of cases of heart valve disease in patients taking only fenfluramine or dexfenfluramine. No cases meeting the FDA’s definition of a case were reported in patients taking phentermine alone.
Ketek – In January 2006, the U.S. Food and Drug Administration issued a public health advisory on the widely prescribed antibiotic Ketek. According to the advisory, the agency had received several reports of liver failure and death associated with the use of the drug. An FDA memo released several months later in May confirmed a total of 23 cases of Ketek-related liver injury, 12 cases of liver failure, 44 instances of less severe liver injury, and four deaths. Agency officials subsequently concluded that there is a clear link between the drug and the risk of liver injury and failure.
Lotronex, generic name alosetron hydrochloride, is a medication developed by GlaxoSmithKline, to treat Irritable Bowel Syndrome. The marketing of Lotronex is being restricted by the FDA because serious and unpredictable gastrointestinal adverse events, including some that resulted in death, were reported in association with its use when it was previously marketed.
Meridia, generic name Sibutramine, is an anti-obesity drug patented by U.S.-based Abbott Laboratories. On March 19, 2002, Public Citizen, a nationwide consumer organization, petitioned the FDA to immediately ban Meridia. According to the FDA database sibutramine has been associated with at least 29 deaths (19 from cardiovascular adverse effects). Its use was suspended in Italy due to two cardiovascular deaths and its safety has been reviewed in other European countries. Reports of common adverse events associated with the use of Meridia include anaphylactic shock, anaphylactoid reaction, facial edema, fluid retention, and lack of drug effect. Other possible side effects include complications with the cardiovascular, digestive, endocrine, lympatic, musculoskeletal, respiratory and nervous systems.
Oxycontin contains oxycodone HCL, an opioid agonist with an addiction potential similar to that of morphine. Opioid agonists are substances that act by attaching to specific proteins called opioid receptors, which are found in the brain, spinal cord, and gastrointestinal tract. When these drugs attach to certain opioid receptors in the brain and spinal cord they can effectively block the transmission of pain messages to the brain. In recent months, there have been numerous reports of OxyContin diversion and abuse in several states. Some of these reported cases have been associated with serious consequences including death.
Prempro and Premarin: Prempro, a combination of estrogen and progestin, is a leading hormone replacement therapy drug. It is prescribed for the treatment of postmenopausal symptoms. Recent studies show long term use of Prempro may increase risks of strokes, heart attacks, blood clots, and breast cancer. The results from this study were so severe that the NIH-National Institute of Health ceased their experiments due to a fear that their participants may be at risk.
Concluding the hormones’ risks outweighed those benefits, the NIH stopped the 16,600-woman study three years early – and is advising other women who use the estrogen-progestin combination to ask their doctors if they, too, should quit.
Premarin shares the same estrogen component as Prempro. It is manufactured by Wyeth. t seller in the nation. Recent studies of the National Institute of Health clearly show that Wyeth’s efforts in studying the results of Premarin were inaccurate. They found that the drug doesn’t prevent heart disease; it in fact may cause it.
Propulsid, generic name Cisapride,is now the target of FDA advisories to physicians of cardiac problems associated with the drug Propulsid, which is a treatment for nighttime heartburn. The FDA’s warning is being issued in conjunction with a “Dear Healthcare Professionals letter” from the drug’s sponsor, Janssen Pharmaceutica of Titusville, NJ. The drug’s labeling has been revised to include new information about the cardiac risks associated with the drug and to recommend that other therapies for heartburn generally be used before Propulsid. These actions were prompted by reports of serious adverse reactions — including heart rhythm disorders and deaths associated mostly with the use of the drug in people who were taking certain other medications or who had particular underlying medical conditions.
Rezulin is marketed by Warner-Lambert and Parke-Davis to treat Type II Diabetes Mellitus. It was pulled from the market on March 21, 2000. Over the months leading up to its recall, there was considerable medical press about damage to the liver that was occurring. The manufacturers had tried to keep the drug on the market by including ever-increasing warnings about this risk, but the only proper solution was withdrawal, especially since there are other drugs on the market affording the same treatment more safely. The specific type of damage, which is part of the lawsuits around the country, is cirrhosis of the liver. This has led to, on occasion, the need for liver transplant, or worse, to death. At the time of its withdrawal from the market, it was estimated that 500,000 people were currently on Rezulin. The drug has been linked to 90 confirmed reports of liver failure, including 60 deaths. Rezulin generated over $1.8 billion in sales.
Serzone, generic name nefazodone hydrochloride, is a medicine manufactured by Bristol-Myers Squibb that is used to treat depression. Serzone is thought to treat depression by correcting an imbalance in the amounts of certain natural chemicals, such as serotonin and norepinephrine, which are in your brain. Cases of life-threatening hepatic failure have been reported in patients treated with Serzone. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 – 300,000 patient-years of Serzone treatment. Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.
Thimerosal is a compound that contains the toxic heavy metal mercury. Since the early 1930s the compound thimerosal was used in vaccines and medicines as a preservative, and to sterilize containers and instruments. For years, vaccinations containing thimerosal where given to infants and small children. The high mercury content of thimerasal poses a serious health risk for children. In the first few months of a baby’s life, an infant may have already received up to 15 vaccinations. The levels of toxic mercury in these vaccinations can cause lasting and serious developmental and neurological problems in these children. The Centers for Disease Control and Prevention has linked mercury-containing vaccines and developmental disorders. Among these disorders are autism, attention deficit disorder, and speech and language deficiencies.
On July 7, 1999, the American Academy of Pediatrics and the U.S. Public Health Service issued a joint statement calling for removal of thimerosal from vaccines. This action was prompted in part by a risk assessment from the Food and Drug Administration.
Vioxx, generic name Rofecoxib, is used as a treatment for signs and symptoms of osteoarthritis, acute pain in adults, and painful menstrual cycles. Serious problems from stomach ulcers, such as bleeding, are well known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx. Other adverse reactions can include liver damage. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, “flu like” symptoms and dark urine.