Despite the disappointing results, the vaccine was generally well-tolerated, with injection-site reactions
cited as the most commonly reported adverse event.
More than 80% of patients in both IM injection study arms experienced painful injection-site reactions
after their first treatment session, 82% of which were mild and 17% moderate.
Mild injection-site reactions
were reported more frequently with blosozumab than with placebo.
were identified by using administrative data, and were confirmed by a medical records review.
are a common complication of subcutaneous MS therapy three times per week for IFNB-1a (Rebif[R], Merck Serono) and every other day for IFNB-1 b (Betaferon[R]/Betaseron[R], Bayer Schering Pharma) or GA.
, pain, bruising, lipoatrophy, flu-like symptoms) as well as cognitive impairment and self-efficacy.
There was no evidence of autoimmune reactions with prolonged use and the most common treatment-related adverse events were injection-site reactions
, which tended to diminish after the first year of treatment, the company said.
Injectable, extended-release naltrexone (Vivitrol, Cephalon), used for the treatment of alcohol dependence, has been linked to adverse injection-site reactions
, some requiring surgery, according to a US Food and Drug Administration (FDA) advisory notice to healthcare professionals released yesterday.
On January 31 the FDA announced that the FUZEON (enfuvirtide) package insert had been changed to include precautions to avoid injection-site reactions
, either using a needle, or the Biojector(r) 2000 needlefree injection system.
Those taking Betaseron experienced significantly more adverse injection-site reactions
than those using Avonex.
The most frequent treatment-related adverse events reported were mild to moderate injection-site reactions
Most common side effects: mild to moderate injection-site reactions
(itching, pain, swelling)