Rapamune® (Sirolimus) Lawyer
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Is Rapamune® Safe?
Rapamune® is an immunosuppressant drug, and by their nature, these types of drugs involve certain risks. But Rapamune® is considered safe if it used as directed on the label, which is to prevent organ rejection in kidney transplant patients over the age of 13.
If the drug is used off-label, that is for reasons for which is has not be approved by the U.S. Food and Drug Administration (FDA), Rapamune® has some very serious risks, including death.
Side Effects of Rapamune®
The medication guide accompanying the drug warns that there is an increased risk of getting serious infections while on the drug. These include infections caused by viruses, bacteria and fungi. There also is an increased risk of getting certain cancers, especially lymphoma and skin cancer.
Other side effects of Rapamune® include:
- Stomach pain
- Joint pain
- Fever
- Urinary tract infection
- Anemia (low red blood cell count)
- Low platelet count (cells that help blood to clot)
- Headache
- Constipation
- Diarrhea
- Nausea
- Swelling of the hands and feet
- Poor wound healing
- Increased levels of cholesterol and triglycerides in your blood
- Adverse effect on kidney function
- Acne
- High blood pressure
- Decreased potassium levels
Patients are told to call their doctor if these side effects do not resolve themselves or become severe. Although the following side effects are uncommon, should they occur the patient is urged to contact their doctor immediately:
- Unusual bleeding or bruising
- Cough
- Hoarseness
- Hives
- Swollen, red, cracked, or scaly skin
- Itching
- Difficulty breathing or swallowing
- Swelling of the face, throat, tongue, lips, eye, hands, feet, ankles, or lower legs
Rapamune® Off-Label Uses and Dangers
A black box warning on the label of Rapamune® tells doctors and patients the drug should not be used as an immunosuppressant for liver or lung transplants. In bold black letters, the label says “Serious complications and death may happen in people who take Rapamune® after a liver or lung transplant.”
Off-label use means using the drug for reasons other than its FDA-approved purposes. Some doctors have been giving patients Rapamune® as an immunosuppressant following liver or lung transplants, sometimes with disastrous results.
Maker Accused of Pushing Off-Label Use
Rapamune®’s maker, Wyeth Pharmaceuticals, Inc., has been accused by two whistleblowers of promoting the drug for off-label purposes. The company’s marketing managers encouraged its salespeople to promote the drug to be used after transplanting not only kidneys, but also for transplanting liver, lung, pancreas, heart, and islet cells.
If your doctor has prescribed Rapamune® for you or a loved one for any off-label purposes, you should contact a Rapamune® lawyer. The medication guide explicitly warns against using Rapamune® for any purpose other than a kidney transplant in patients 13 years old or older. Using Rapamune® for other purposes can put your life in danger.
