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|FDA Approves Expanded Label for AZILECT® for Treatment Across All Stages of Parkinson’s Disease|
“The FDA approval of the expanded label for AZILECT® will be
a welcome addition in the treatment of PD,” said
“AZILECT® has been well studied and has been shown to be safe
and effective as monotherapy in early PD and as an adjunct to LD in
moderate-to-advanced PD. The ANDANTE study provides evidence that AZILECT®
is also effective as an adjunct to dopamine agonist therapy,” said
AZILECT® (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).
IMPORTANT SAFETY INFORMATION
Do not take AZILECT if you are taking meperidine as it could result in a serious reaction such as coma or death. Also, do not take AZILECT with tramadol, methadone, propoxyphene, dextromethorphan, St. John’s wort, or cyclobenzaprine. You also should not take AZILECT with other monoamine oxidase inhibitors (MAOIs), as it could result in an unsafe rise in blood pressure.
Increases in blood pressure may occur during treatment with AZILECT. Inform your physician if you have a history of high blood pressure. Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, difficulty thinking, seizure, chest pain, and nausea/vomiting. It is important that if you experience these symptoms that you speak with your doctor or seek medical attention. When AZILECT is taken at recommended doses, restriction of foods and beverages containing a substance called tyramine is ordinarily not required. However, it is recommended that you avoid foods containing high amounts of tyramine such as aged cheeses as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure as described above.
Inform your physician if you are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and ciprofloxacin. The combination of MAO-B inhibitors such as AZILECT and antidepressants has resulted in a serious and sometimes fatal condition called serotonin syndrome.
If you experience episodes of falling asleep or drowsiness during activities of daily living, do not drive and exercise caution until you contact your physician.
If you have moderate to severe liver disease, you should not take AZILECT. You should not exceed a dose of 0.5 mg per day of AZILECT if you have mild liver disease or are taking ciprofloxacin. Patients should not exceed a dose of 1 mg per day of AZILECT because of the risk of increased blood pressure.
All PD patients should be monitored for a change in blood pressure, uncontrolled movements (dyskinesia), hallucinations, impulse control, confusion, and melanoma (skin cancer). A possible rise in body temperature may occur upon stopping AZILECT.
The most common side effects seen with AZILECT alone are flu syndrome, joint pain, depression, and indigestion; when taken with a dopamine agonist are swelling of the legs, fall, joint pain, cough, and inability to sleep; and when taken with levodopa are uncontrolled movements (dyskinesia), accidental injury, weight loss, low blood pressure when standing, vomiting, anorexia, joint pain, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and swelling of tendons.
You are encouraged to report negative side effects of prescription drugs
Please see full prescribing information at www.azilect.com/Resources/pdf/PrescribingInformation.pdf
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This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE® (including
competition from orally-administered alternatives, as well as from
potential purported generic equivalents); the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters; our
ability to achieve expected results from the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.