PAINTREATMENT
Migraine Medication Provides Relief
FIGURE
Pfizer has received FDA approval for its acute treatment of migraine, eletriptan HBr (Relpax) tablets. Eletriptan is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist that acts at serotonin 5HT1B receptors on intracranial blood vessels and 5HT1D receptors on sensory nerve endings to relieve the pain and associated symptoms of a migraine attack.
In clinical trials involving over 9,000 patients, eletriptan was shown to relieve migraine pain and associated symptoms, including nausea and sensitivity to light and sound.
Eletriptan is available in 20-mg and 40-mg doses; the maximum recommended single dose of eletriptan is 40 mg.
The most common side effects reported in clinical trials included fatigue, somnolence, nausea, and dizziness. Eletriptan should not be used by patients with severe hepatic impairment, or those older than 65 years, or younger than 18. Eletriptan should not be used within 72 hours of potent CYP3A4 inhibitors.
Pediatric 5-in-1 Vaccine Available
GlaxoSmithKline's new combination vaccine, Pediarix, is now FDA-approved to protect infants against diphtheria, tetanus, pertussis, polio, and disease caused by the hepatitis B virus. Use of the combination vaccine can result in up to 6 fewer immunization injections for infants.
Pediarix is the only US-marketed vaccine that contains DtaP (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), hepatitis B vaccine (recombinant), and inactivated poliovirus vaccine (IPV) for administration as one intramuscular injection. The Infanrix (DtaP) and Engerix-B (hepatitis B) components used in Pediarix were previously licensed in the US.
The new vaccine is recommended for administration as a 3-dose primary series to infants at approximately 2, 4, and 6 months of age. Pediarix should not be given to infants under the age of 6 weeks and is not indicated for infants born to mothers infected with hepatitis B or whose hepatitis B status is unknown. In clinical studies of Pediarix, adverse events included injection-site reactions, fever, and fussiness.
Pediarix is associated with higher fever rates relative to separately administered vaccines and is contraindicated in infants with known hypersensitivity to any component of the vaccine including yeast, neomycin, and polymyxin B.
Rheumatoid Arthritis Treatment Approved
The FDA approved Abbott's adalimumab (HUMIRA) for the treatment of rheumatoid arthritis (RA). The medication is indicated to reduce signs and symptoms of RA and inhibit structural damage in adult patients with moderately to severely active RA who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs).
This human-derived antibody is made from recombinant DNA technology, which blocks human tumor necrosis factor alpha (TNF-alpha). By working against the inflammatory process, the new medication controls symptoms of RA. Adalimumab can be used alone or in combination with methotrexate or other DMARDs.
The drug is administered as a single subcutaneous injection every other week. Abbott plans to market a specially-designed prefilled syringe for RA patients whose hands are affected by the disease.
The safety and efficacy of adalimumab was assessed in clinical trials in adults. Over half the patients experienced a reduction in signs and symptoms of RA. One study that used radiographic evaluations showed that after one year, patients treated with adalimumab and methotrexate demonstrated less joint deterioration than patients receiving methotrexate alone.
Consult product labeling for important warnings associated with adalimumab and other TNF-blocking agents.