Gleevec Lawsuit

Gleevec Lawsuit: What is Gleevec?

Gleevec, which goes by the generic name Imatnib, is prescribed to patients with certain types of leukemia (cancer that starts in the white blood cells). Gleevec may also be prescribed to treat gastrointestinal stromal tumors. Gleevec belongs to a group of medications known as protein-tyrosine kinase inhibitors. Gleevec is effective by obstructing the action of the abnormal proteins that signal cancer cells to multiple; this function ultimately helps stop the spread of cancerous cells.

Gleevec comes as a tablet and should be ingested orally. Gleevec is typically taken with a meal and a large glass of water. Gleevec should be taken at around the same time each day. If prescribed Gleevec, you must take the medication exactly as directed. Never take more or less of Gleevec then as directed by your medical professional.


Gleevec Side Effects:

Gleevec may cause side effects. Please tell your doctor if any of these Gleevec side effects are severe or persistent:

• Gleevec side effects include diarrhea, constipation, gas and nausea

• Gleevec side effects include vomiting, indigestion and loss of appetite

• Joint pain and muscle cramps are also Gleevec side effects

• Depression, teary eyes and night sweats are common Gleevec side effects

Some Gleevec side effects may be more severe in nature. If you experience any of the following Gleevec side effects, please contact your healthcare professional or doctor immediately:

Severe side effects associated with Gleevec include puffiness under the eyes, swelling of the feet, ankles, hands or lower legs

• Weight gain and shortness of breath are also classified as severe Gleevec side effects

• Difficulty falling or staying asleep is classified as a severe Gleevec side effect

• Yellowing of the skin or eyes is classified as a severe Gleevec side effect

• Unusual bleeding or bruising is classified as a severe Gleevec side effect

• Sore throat, chills, fevers and other signs of infection are severe Gleevec side effects

• Dizziness, headaches and excessive weakness or tiredness are all deemed Gleevec side effects

Gleevec’s most severe side effects, and the reaction that prompts the bulk of Gleevec lawsuits surrounding the drug, concerns an increase in congestive cardiac failure. Also, if Gleevec is used in prepubescent children, it may delay normal growth. That being said, Gleevec is commonly referred to as a miracle drug. Case studies have shown a complete hematologic response in overwhelming percentages of patients. Recently the results of a five-year study found a complete hematologic response in 98% of patients.

Gleevec was initially approved for use by the United States Food and Drug Administration in 2001 for the treatment of chronic myelogenous leukemia. Since its initial approval, the drug has also been approved for use in patients with several types of tumors.

As a result of its success, there hasn’t been one Gleevec settlement delivered to a patient citing Gleevec side effects as the primary cause of illness or death.

The only significant Gleevec lawsuit came in the form of a patent contest. Novartis, the manufacturer of Gleevec, claimed that India was violating patent laws. A victor for Novartis would make it difficult for Indian companies to produce generic versions of drugs under patent elsewhere in the world. In response, Doctors without Borders argued that a change in law would make it nearly impossible for Indian companies to produce cheap medication, therein making it impossible for Third World nations to purchase these essential medications. In August of 2007, the Indian Madras High Court dismissed the writ petition filed by Novartis and deferred it to the World Trade Organization where it remains unresolved.

Sources:

1. "FDA Highlights and Prescribing Information for Gleevec(imatinib mesylate)".

2. United States National Library of Medicine retrieved from:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000345/

3. http://www.fda.gov/drugs/drugsafety/

postmarketdrugsafetyinformationforpatientsandproviders/ucm110502.htm

4. http://www.fda.gov/NewsEvents/Newsroom/

PressAnnouncements/ucm289760.htm