Rezulin | Ephedrine | Propulsid
If you or a family member suffered injuries including liver and heart damage as a result of using Rezulin (troglitazone) the popular diabetes drug you should speak to a lawyer to protect your rights. Our lawyers represent victims of Rezulin, a drug that won "fast track" FDA approval but unfortunately has been associated with liver failure and deaths. Our lawyers will provide you with a free case assessment. All correspondence is confidential and private. We provide referrals to attorneys nationwide.
The Rezulin Recall
On March 21, 2000 head of the FDA's center for Drug evaluation and Research stated that the "Continued use of Rezulin" posed an "unacceptable risk " to diabetes patients. At least 63 Rezulin users have died of liver failure. The total number of deaths is estimated to be as many as ten times higher than the reported 63 cases.
Rezulin was banned in England in December 1997, following the death of an American who took the drug. The drug manufacturer, Warner-Lambert successfully fought a ban in the U.S. for 27 months before the FDA decided to prohibit sales of the drug on March 21, 2000. Before the ban, sales of Rezulin generated Warner-Lambert $1.8 billion in revenues. At its peak, the drug was prescribed 488,000 times in January of 1999.
63 Rezulin users have reportedly died from use of the drug. The deaths were caused by liver failure. The total number of deaths is likely to exceed 63 by many times according to experts.
The March 21, 2000 ban of Rezulin came about after a long debate inside the FDA. Many doctors believed Rezulin was a dangerous drug that needed to be banned. Many inside the FDA believed along with Warner-Lambert's consultants that Rezulin was safe if properly administered and that it should not be pulled from the market.
The recall came after an FDA whistleblower shared his findings and internal FDA email messages with a L.A. Times reporter. This information and interviews with several doctors led to a series of articles in the Los Angeles Times discussing the dangers of Rezulin. The articles also raised questions about the irregular FDA's "fast track" approval of the drug.
Rezulin was used treat type 2 (non-insulin-dependent) diabetics who are using insulin. It lowers the amount of sugar in the blood by helping the body respond better to the insulin.
Why it was prescribed?
Doctors prescribed Rezulin in type 2 diabetics who take insulin but whose blood sugar is not well controlled. It was designed to help insulin (either your own or injected) work better, drawing the sugar from your blood into the cells to supply energy.
The drug was approved for diabetics who are insulin users, those taking certain types of oral antihyperglycemic medications, or for diabetics whose diabetes could no longer be controlled by diet and exercise alone.
Rezulin came in 200-milligram (mg) and 400-mg tablets. The maximum dose was 600 mg a day.
The product is also known generically as troglitazone
Brand name: Rezulin (US), Noscal (Japan)
Route of Administration: oral
Dose: 200 mg with a meal; if no improvement within a few weeks, can increase to 400 mg with a meal (and later to 600 mg).
Previously available as: 200 mg, 300 mg, and 400 mg tablets.
Previously recommended by FDA for: Type 2 diabetes, in combination with sulfonylurea pills, or combination with both
sulfonylurea pills and metformin, or with insulin injections.
Action: improves the action of the liver, muscles, and fat tissues (functions as an "insulin sensitizer")
Side Effects: Fluid retention, increased fertility, liver disease (see below).
US manufacturer: Parke-Davis division of Warner-Lambert (Developed by Sankyo Pharmaceutical Company in Japan)
Status: Withdrawn by the manufacturers March 21, 2000 in the USA, and in Japan, the Philippines, and Australia.
Suspended in the United Kingdom in December, 1997 pending review of safety data and later withdrawn from the UK market.
Other drugs in same class: pioglitazone, rosiglitazone
According to the FDA Ephedrine also know as Ephedra or Ma Haung has Sickened or Killed 273 Users. The most
serious cases involve death, heart attack and stroke.
The Food and Drug Administration believes there may be 273 people who fell ill, some fatally, after taking the
popular over-the-counter stimulant ephedra found in products like Metabolife 356.
While the agency wouldn't verify how many people died as a result of taking the herbal stimulant, often used to
promote weight loss, earlier reports put the number at about 30. A source familiar with the latest cases, who asked
not to be identified, says they include an additional 10 deaths.
The FDA has already tried once to bring ephedra under its regulatory control. In June 1997, the agency proposed a
rule that would limit the amount of ephedra that could be added to dietary supplements. It also sought warning
labels on the products cautioning against taking them for more than a week. At the time, the FDA submitted 133
cases of people who, it said, had been harmed by ephedra.
Ephedra, derived from an Asiatic shrub, contains ephedrine, a stimulant that acts on the central nervous system to
like Sudafed and Actifed, which fall under the FDA's watch.
Many people with heartburn and infants with colic who took Propulsid have experienced:
Sudden cardiac arrhythmia death
Cardiac arrest or heart attack
Over 111 people have died as a result of Propulsid related conditions, nearly 400 have heart abnormalities.
Propulsid has been withdrawn from the market.
Propulsid (cisapride) can cause fatal heart rhythm problems- according to Janssen Pharmaceutica and the FDA. Indeed at least 111 people have died as a result of Propulsid related conditions, and nearly 400 have developed heart abnormalities.
Cases of serious heart arrhythmias, including ventricular fibrillation, ventricular arrhythmias and torsades de pointe and QT prolongation, cardiac arrest and sudden death have been observed in people taking Cisapride (Propulsid). In rare cases, seizures have been reported. Nervous system side effects have included headaches, dizziness and fatigue.
Risks to Children
Although propulsid was approved for adult use- many children, mostly infants and premature babies, took propulsid - and some have died or suffered irregular heartbeats.
Propulsid is not an antacid but instead helps push food through the stomach. How safe is it? Of the 70 deaths originally reported by the FDA, 11 were children and 20 children suffered heart rhythm disturbances.
Heart arrhythmias are irregularities in the beating and pumping action of the heart. The heart is a muscular pump divided into four chambers--two atria located on the top and two ventricles located on the bottom. Under normal conditions the heartbeat starts in the right atrium. In the right atrium a specialized group of cells called the sinus node, or pacemaker, send an electrical signal that spreads throughout the atria to the area between the atria called the atrioventricular (AV) node. The AV node connects to a group of special pathways that carry the signal to the ventricles below. As this signal traveling through the heart causes the heart to contract. First the atria contract, pumping blood into the ventricles. Within a fraction of a second later, the ventricles contract, pumping blood throughout the body. The heart normally contracts between 60 and 100 times per minute. Each contraction equals one heartbeat.
What is a Heart Arrhythmia?
Heart arrhythmias occur when the heartbeat does not originate in the sinus node-but in another part of the heart. The sinus node develops an abnormal rate or rhythm.
How is Heart Arrhythmia diagnosed?
The ECG is the basis for all arrhythmia diagnosis. The ECG tracing is a series of waves that represent the electrical events of the various chambers and conduction pathways within the heart. The small initial wave, called the P wave, represents the electrical activation of the atria. Next comes the QRS complex, the tallest wave on the ECG, representing the stimulation of the ventricles. Finally, the T wave represents the period when the ventricles recover their electrical forces so they may be stimulated again. The normal rhythm of the heart produces a regular pattern with a rate of between 60 to 100 beats per minute. An irregular rhythm can be detected by charting the pattern of the ECG.
Types of Heart Arrhythmia
The heart may beat too rapidly, a situation called tachycardia or too slowly, a situation called bradycardia; or it may beat irregularly.
An arrhythmia may result in a skipping or fluttering sensation in the chest (palpitations), light-headedness, a fainting spell (syncope), chest pain, or shortness of breath. Although arrhythmias may go unnoticed, they can be serious. In general, arrhythmias are more common in people with heart disease (especially coronary heart disease, defective heart valves, or a weakened heart). The heart may beat too slowly or too rapidly to pump blood effectively and the blood pressure may drop to a level that is life-threatening. If left untreated, the heart may stop beating and these people could die. However, having an arrhythmia does not necessarily mean that a person has heart disease. In fact, arrhythmias may occur in people with an otherwise normal heart.
Factors that can bring on arrhythmias in otherwise healthy patients include caffeine, smoking, drugs, alcohol, and stress. People with arrhythmias should be properly evaluated to determine if their problem poses significant risk to their health (or their life), especially since effective treatment or even cure is possible in many cases.
Propulsid and Heart Problems
The problem mainly involves QT prolongation, a defect in the conduction of electrical current through the heart that can, in rare cases, lead to problems such as ventricular fibrillation and sometimes complete heart block leading to cardiac arrest. Many of the serious reactions to Propulsid occurred in patients who were taking other medications or suffering from other conditions that increased their risk of cardiac arrhythmia when taking Propulsid.
If you have taken any of these dangerous drugs contact us.