Iowa Woman Sues Makers of Zelnorm
Ginger Marolf, an Iowa resident, has filed a lawsuit against Novartis, the pharmaceutical company that manufacturers Zelnorm. The lawsuit alleges that the drug caused her to suffer from permanent heart injuries. The U.S. Food and Drug Administration asked Novartis Pharmaceuticals to recall Zelnorm in 2007. This recall was the result of studies, which revealed that the drug caused an increased risk of cardiovascular side effects.
Ginger Marolf’s attorney said that she used this drug for around 5 years from 2002 to 2007, she has no history of any heart problem prior to use of this drug. After use of this drug, she developed cardiovascular problems. She even required angioplasty and has to go for placement of stents in her heart.
The lawsuit accused Novartis of hiding the facts about risks of Zelnorm. It alleges that even though the pharmaceutical company was aware of the serious side effects of Zelnorm, it did not provide this information to the public or healthcare professionals. It also alleged that the studies revealed its adverse effects on cardiovascular system in as early as 2004, the company hid it until 2007, when it recalled the drug.
After a safety study revealed that the use of Zelnorm could increase the risk of heart attack, stroke and chest pain, the U.S. Food and Drug Administration ordered Novartis to recall the drug from market. The FDA permitted the limited use of Zelnorm for women younger than 55 in July 2007. But later in April 2009, the drug’s side effects risk forced it to reverse its decision.
Zelnorm is brand name for tegaserod maleate. It is used for treatment of constipation-related irritable bowel syndrome in women. In irritable bowel syndrome abdominal pain occurs frequently with constipation or diarrhea. It is also used to treat severe constipation in patients below 65 years of age. It acts by increasing action of serotonin in intestine. Serotonin is a chemical, which affects bowel movement. In constipation contraction in intestine is less. It helps Serotonin to increase contraction in intestine and results in relief from constipation.
Use of this drug could lead to side effects such as headache, dizziness or migraine, back pain or joint pain and mild stomach pain, nausea or gas. It could also increase stomach pain, blood in stools, ongoing diarrhea, severe stomach pain or cramps or feeling like fainting. This drug has been related to heart injuries. It has been accused of causing heart-related injuries in patients using it. This side effect has led to recall of Zelnorm in 2007.
Novartis agreed to discontinue marketing Zelnorm, after an FDA analysis of safety data, which was collected from 29 clinical trials and was involving over 18,000 patients, revealed its relation to cardiovascular problems. Study found an excess number of serious cardiovascular problems occurring in patients, who used Zelnorm. These problems were angina, heart attacks and stroke.
Ginger Marolf was seeking medical expenses as well as compensation for her pain and suffering due to use of this drug. Various studies show that claims of heart attacks due to this drug is true in many patients.