"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
Didronel Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: new or worsening bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, mental/mood changes, signs of infection (such as fever, persistent sore throat).
This medication may infrequently cause irritation and ulcers in your stomach or esophagus. Seek immediate medical attention if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult/painful swallowing, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.
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 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 Didronel (etidronate disodium) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking etidronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate); 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain bone disorder that causes soft/painful bones (osteomalacia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, inability to sit upright or stand for at least 30 minutes, difficult/painful swallowing, esophagus problems (such as esophageal stricture, achalasia), stomach/intestinal problems (such as heartburn, ulcers, colitis), low level of calcium in the blood.
Some people taking etidronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.
Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking etidronate before your surgery. Ask for specific instructions about stopping or starting this medication.
Caution is advised if you are pregnant or planning to become pregnant in the future. This medication may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with this medication.
It is not known if this medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.
Additional Didronel 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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