Lotronex

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Frequently Asked Questions

The following FAQs are intended to provide information in lay terms for people who used the drug Lotronex. This material is not intended to be a legal document and is for informational purposes only. Please contact our offices if you require further information.


 
What is Lotronex?

  What is irritable bowel syndrome (IBS)?

  How does Lotronex work?

  Who should take Lotronex?

  Why is Lotronex controversial?

  Why was Lotronex pulled off the market?

  What is ischemic colitis?

  Why was Lotronex allowed back on the market?

  What are the risks of Lotronex?

  Do the benefits of Lotronex outweigh its risks?

  What should I do if I think I'm suffering from Lotronex side effects?

 


 

What is Lotronex?

Lotronex is GlaxoSmithKline's brand name for its drug alosetron, which is used to treat some cases of irritable bowel syndrome. Lotronex was introduced in February 2000 but pulled off the market nine months later because of serious side effects. However, in June 2002, the U.S. Food and Drug Administration allowed Lotronex back on the market under new restrictions.

 


 

What is irritable bowel syndrome (IBS)?

IBS is a chronic and painful condition marked by diarrhea, constipation or both. In severe cases, people may be unable to control their bowels, preventing them from leading a normal life at work or at home.

 


 

How does Lotronex work?

Lotronex slows the movement of stools through the body. It does not cure IBS, and it is approved only for certain types of IBS.

 

People who are helped by Lotronex may find it eases stomach pain, reduces the sudden need to have a bowel movement, and reduces diarrhea.

 


 

Who should take Lotronex?

The FDA has approved Lotronex specifically for women with IBS in cases where all of the following apply:

  • The major problem is diarrhea rather then constipation.
  • The condition has been present for at least six months.
  • A doctor has ruled out other medical problems.
  • Other treatments have failed to help.
  • The condition causes painful cramps or bloating, or the inability to control bowel movements.

 


 

Why is Lotronex controversial?

GlaxoSmithKline and the FDA have been blamed for rushing the drug to market, despite known side effects. Critics say that the safety of patients has not been adequately protected.

 

Some patients believe that by letting them lead a normal life, Lotronex' benefits are worth the serious risk of side effects.

 


 

Why was Lotronex pulled off the market?

Lotronex was blamed for severe gastrointestinal problems in 141 people -- including 96 who were hospitalized and five who died. The drug's side effects include constipation severe enough to rupture bowels, requiring the removal of part or the entire colon, or even causing death.

 


 

What is ischemic colitis?

Ischemic colitis is another side effect of Lotronex, where blood flow to the colon is restricted causing gangrene and death.

 


 

Why was Lotronex allowed back on the market?

Patient groups protested Lotronex’ removal. The FDA could have re-approved Lotronex as an experimental drug, under tight restrictions, but GlaxoSmithKline refused.

 

So in a move that some see as caving in to the drug maker, the FDA re-approved Lotronex under less stringent restrictions.

 

Part of the re-approval involved a program to educate patients and curtail inappropriate prescriptions. But the program is run by GlaxoSmithKline, which has been called a clear conflict of interest.

 


 

Do the benefits of Lotronex outweigh its risks?

Some IBS patients think so. But IBS, though debilitating, is not life-threatening -- while the side effects of Lotronex can be. Each patient must make his or her own informed decision, the FDA says.

 


 

What should I do if I think I'm suffering from Lotronex side effects?

Talk to your doctor promptly. Ischemic colitis, in particular, can strike with little or no warning.

And if you or a loved one has been injured by taking Lotronex, contact the office of Monheit Law promptly to see if you have a legal case.

Each state sets strict deadlines for people who have been injured to a  o lawsuit, and the deadlines vary from state to state. So it's important that you get legal advice as soon as possible


 

Do I have a Lotronex case?

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