March 11, 2015
PR Newswire -- Bayer HealthCarePharmaceuticals has become aware of a broad United States market recall ofalcohol prep pads, swabs and swabsticks manufactured by the Triad Group andmarketed under various brand names. In the interest of patient safety,Bayer wants to ensure that U.S. patients and physicians using Bayer's Betaseronare aware of the Triad recall.
The recall of the Triad Groupalcohol prep products is due to potential contamination of these products withthe bacteria, Bacillus cereus, that could lead to life-threatening infections.
Triad alcohol prep pads packaged foruse in the U.S. with Betaseron should not be used by patients. There isNO involvement or potential contamination of the Betaseron vial or othercomponents in the Betaseron U.S. packaging. This issue is confined tothe actual Triad alcohol prep products. Triad alcohol prep products arenot used in Betaseron packaging outside of the United States.
Bayer instructs patients usingBetaseron to immediately discontinue using the Triad alcohol prep pads includedin the Betaseron packaging and dispose of those pads in the trash. Whenpreparing to take their Betaseron injection, patients should use an alternativealcohol prep pad that is not subject to this Triad recall or use a sterilegauze pad in conjunction with isopropyl alcohol.
Bayer is currently in the process ofgathering additional information from both Triad and the U.S. Food and DrugAdministration. In the interim, Bayer has halted shipments of Betaseronto its distribution network, until it can affect a replacement for the alcoholprep pad. Bayer has posted this important information on its websites.
Further information on this Triadrecall can be found on the FDA website at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm. If you have additional questions, please consult with your pharmacist orhealthcare provider or contact BETAPLUS at 1-800-788-1467 option 1 to speak toa BETA Nurse. Or call Bayer at 1-888-84-BAYER, where operators will beavailable 24 hours a day to respond to questions from consumers or medicalprofessionals. Members of the media should call Rosemarie Yancosek at973/305-5213 or Rose Talarico at 973/305-5302.
Bayer will provide additional informationwhen it becomes available.
BETASERONÂ® (interferon beta-1b) isindicated for the treatment of relapsing forms of multiple sclerosis to reducethe frequency of clinical exacerbations. Patients with multiple sclerosis inwhom efficacy has been demonstrated include patients who have experienced afirst clinical episode and have MRI features consistent with multiplesclerosis.
IMPORTANT SAFETY INFORMATION
BETASERON should be used with caution in patients with depression.
Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites.
Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON.
BETASERON should be used with caution in patients with seizure disorders or cardiac disease.
Female patients should be warned about the potential risk to pregnancy.
Cases of anaphylaxis have been reported rarely.
The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flu-like symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms.
Source: Bayer HealthCarePharmaceuticals
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