"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"...
Thalomid Consumer (continued)
Drowsiness, dizziness, constipation, weakness, and dry skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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.
Thalidomide may cause possibly severe nerve damage, which may be permanent. This may occur during treatment or after treatment has stopped. Tell your doctor immediately if you develop any of the following symptoms: numbness/tingling/pain/burning in the feet or hands, muscle weakness/cramps, feeling of tightness in the feet.
People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia). Consult your doctor for more details.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, anxiety), shaking (tremor), shortness of breath, arm/leg swelling, fast/slow heartbeat, signs of infection (e.g., fever, persistent sore throat).
Get medical help right away if you have any very serious side effects, including: seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Thalomid (thalidomide) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking thalidomide, 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.
This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem (neutropenia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: numbness/tingling of arms/legs, seizures.
Caution is advised when using this drug in people with HIV because they may be more sensitive to the effects of the drug. While thalidomide is used to treat muscle wasting and other HIV-related conditions, the drug might affect the amount of HIV in your system (viral load). Therefore, the manufacturer recommends having HIV tests from time to time.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.
Thalidomide must not be used during pregnancy due to the risk of severe birth defects and other serious, sometimes fatal harm to an unborn baby. If you are female and become pregnant or think you may be pregnant, if your period is late or you have unusual menstrual bleeding, or if you stop using 2 forms of birth control, stop taking thalidomide and tell your doctor immediately. If you are male and have had unprotected sex with a woman who can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors immediately. (See also Warning section.)
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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