"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Quadramet Consumer (continued)
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection (e.g., fever, chills, persistent sore throat/cough, pain when you urinate).
Tell your doctor immediately if any of these unlikely but serious side effects occur: easy or unusual bleeding/bruising (e.g., bloody nose, bloody/black/tarry stools, bloody/pink urine), unusual weakness/tiredness, pounding/persistent headache, fast/slow/irregular heartbeat.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Quadramet (samarium sm 153 lexidronam) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., heart failure, irregular heartbeat), kidney problems, urinary/bladder problems (e.g., incontinence), decreased bone marrow function, blood disorders (e.g., bleeding problems, low platelet count, blood clotting problems), weakened immune system, low blood calcium levels.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.
Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Women should have a negative pregnancy test before treatment. It is recommended that men and women receiving this medication use reliable forms of birth control (e.g., condoms, birth control pills) to prevent pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control.
It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
Additional Quadramet Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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