Rapamune® (Sirolimus) Lawsuit
If you or a loved one was given Rapamune® for off-label uses and have suffered harmful side effects, you might be eligible to file a Rapamune lawsuit.
Rapamune® Injuries
Rapamune® is a drug in the class of medications called immunosuppressants that are prescribed to prevent the rejection of transplanted kidneys in patients 13 years old and older.
When the drug is used off-label, that is for preventing transplant rejection of organs other than kidneys, the consequences can be severe, including death. Some doctors have used Rapamune® in liver or lung transplant patients with serious results.
In bold black letters, the drug medication guide says that, “Serious complications and death may happen in people who take Rapamune after a liver or lung transplant.”
In one study, liver transplant patients were started on one kind of immunosuppressive treatment (calcineurin inhibitor-based immunosuppressive regimen or “CNI”), then switched to Rapamune®. Wyeth Pharmaceuticals Inc., the manufacturer of the medication, conducted the clinical trial. Researchers found that a significantly higher number of deaths occurred in patients converted to Rapamune® than in patients who remained on CNI.
The medication guide also warns that Rapamune® can increase a patient’s chances of getting certain cancers, lymphoma in particular, and skin cancer. Patients are cautioned to reduce their risk of skin cancer by avoiding prolonged exposure to sunlight and to wear protective clothing, sunglasses and sunscreen. They are urged to call their doctors immediately if any of the following symptoms occur:
- Fever
- Sore throat
- Chills
- Frequent or painful urination
- Other signs of infection
- New sores or changes in the skin
- Night sweats
- Swollen glands in the neck, armpits or groin
- Unexplained weight loss
- Difficulty breathing
- Chest pain
- Weakness or fatigue that does not go away
- Pain, swelling, or fullness in the stomach
Other side effects that can result from taking Rapamune® include:
- High blood pressure
- Decreased potassium levels
- Acne
- Increased blood levels of cholesterol and triglycerides
- Poor wound healing
- Headache
- Diarrhea
- Constipation
- Slow blood clotting
- Fever
- Joint pain
- Stomach pain
- Headache
- Nausea
- Swelling of the hands and feet
- Urinary tract infection
Rapamune® Lawsuits for Off-Label Use
In a whistleblower lawsuit, two former Wyeth employees charged the drug company for promoting off-label uses of the medication. That means the company supposedly was encouraging doctors to prescribe the medication for uses other than prevention of kidney rejection after a transplant.
It is illegal for a pharmaceutical company to promote a drug for off-label uses. When the U.S. Food and Drug Administration approves a drug, it always prescribes what the drug can be used for. Any other uses are considered to be “off-label.”
The whistleblowers, two former company sales representatives, also charged that Wyeth targeted two hospitals with primarily African American patients for off label uses of the drug. They are Philadelphia’s Einstein Medical Center and New York’s SUNY Downstate Medical Center.
If you or someone you love has received Rapamune® for any reason other than preventing the rejection of a transplanted kidney, you should speak with a Rapamune® attorney. We may be able to help you seek compensation for your injuries and loss.
