Betaseron Side Effects
From Pharmacy Drug Guide
Betaseron is the brand name for interferon beta-1b, a medication that is prescribed to patients suffering from multiple sclerosis (MS) to minimize flare-ups that can lead to permanent nerve loss.[1] Betaseron is administered via self-administered, subcutaneous injection every other day.[2] Interferons are proteins that occur naturally in the body that are used by cells to communicate information within the immune system.[1] In particular, Betaseron will shield the material in the body that protects nerve fibers, called myelin, by preventing T-cells and proteins from attacking it.[3] Approved by the FDA on July 23, 1993, Betaseron was the first disease-modifying therapy approved for relapsing forms of multiple sclerosis.[4]
 U.S. Brookhaven National Laboratory | |
| Brand name for | Interferon beta-1b |
|---|---|
| Manufacturer | Bayer HealthCare Pharmaceuticals[5] |
| Uses | Helps to decrease flare-ups associated with multiple sclerosis |
| Common side effects | Injection-site reaction, flu-like symptoms, general weakness, headache, and pain[3] |
| Who should not take Betaseron? | Patients suffering from depression, seizure disorders and heart disease |
| Disclaimer | The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician. |
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Common Betaseron Side Effects
Patients taking Betaseron may experience redness, swelling or pain at the injection site. Four percent of patients in controlled clinical trials experienced injection-site necrosis (severe skin damage). These occurred within the first 4 months of treatment and resulted in open skin lesions that were approximately 3 cm in diameter.[6]
As with other interferon compounds, Betaseron has been known to cause depression, anxiety, and suicide ideation in some patients. This medication should be used with caution in patients with a history of depression.[2]
Other common side effects include lymphopenia, or low white blood cell count); weakness/loss of energy; headache; pain; and flu-like symptoms: fever, chills, muscle aches, sweating and fatigue. [6]
About Drug Side Effects
Betaseron Allergic Reactions
The use of Betaseron is not recommended for patients with a known hypersensitivity or allergy to Interferon beta-1b or to any of the following inactive ingredients: human albumin, mannitol USP, or diluent sodium chloride solution.[6]
Allergic reactions to Betaseron have been known to occur both upon receiving the first dose and after a patient has been taking the drug for a while. Severe allergic reactions might include difficulty in breathing and swallowing, which may require immediate medical attention. Less severe reactions include rash, itching, skin bumps, and swelling of the mouth and tongue.[2]
Betaseron Precautions and Warnings
- Betaseron is not recommended for patients who have a history of seizure disorder, or a pre-existing cardiac disease such as coronary artery disease or congestive heart failure.[2]
- Betaseron can cause liver damage or failure. Patients who experience jaundice--yellowing of the eyes and skin--or easy bruising may be experiencing liver distress.[2]
- Betaseron is classified as FDA pregnancy category C. Clinical studies demonstrated the possibility of miscarriage in pregnant rhesus monkeys who were given Betaseron. It is not clear if the same result would occur in humans. The manufacturer suggests that women who become pregnant while taking Betaseron discontinue its use. There is a Betaseron Pregnancy Registry to monitor pregnancy outcomes of women exposed to Betaseron while pregnant.[7][2]
- It is not known if Betaseron can pass through breast milk in nursing mothers or the seriousness of adverse reactions that could occur for a nursing infant.[2]
Also See: Drug Side Effects, Tysabri Side Effects, Gilenya Side Effects, Gilenya Patient Assistance Programs, Gilenya Free Samples, Humira Side Effects, Copaxone Side Effects, Avonex Side Effects, Rebif Side Effects
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References
- ↑ 1.0 1.1 http://www.betaseron.com/patients/about_betaseron/
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf
- ↑ 3.0 3.1 http://www.betaseron.com/patients/about_betaseron/how_betaseron_works.jsp
- ↑ http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
- ↑ http://www.bayer.com/
- ↑ 6.0 6.1 6.2 http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=261fde67-efb2-4bd7-947e-4f68a56e76ff
- ↑ http://www.BetaseronPregnancyRegistry.com
