"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
The following adverse reactions are listed in decreasing order of severity, without regard to causality, within each body system category and have been reported during clinical trials, with use of the marketed vaccine, or with use of polyvalent vaccine containing rubella:
Body as a Whole
Hemic and Lymphatic System
Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history.
Chronic arthritis has been associated with natural rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients developed chronic joint symptoms.
Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-26%)7,36,37 and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women. Even in women older than 35 years, these reactions are generally well tolerated and rarely interfere with normal activities. Myalgia and paresthesia have been reported rarely after administration of MERUVAX (rubella virus vaccine live) II.
Special Senses — Ear
Nerve deafness; otitis media.
Special Senses — Eye
Optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis.
Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established. No deaths or permanent sequelae were reported in a published post-marketing surveillance study in Finland involving 1.5 million children and adults who were vaccinated with M-M-R II during 1982-1993.38
Under the National Childhood Vaccine Injury Act of 1986, health-care providers and manufacturers are required to record and report certain suspected adverse events occurring within specific time periods after vaccination. However, the U.S. Department of Health and Human Services (DHHS) has established a Vaccine Adverse Event Reporting System (VAERS) which will accept all reports of suspected events.31 A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967. 31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.
Read the Meruvax (rubella virus vaccine live) Side Effects Center for a complete guide to possible side effects
The immune status of patients about to undergo immunosuppressive therapy should be evaluated so that the physician can consider whether vaccination prior to the initiation of treatment is indicated (see CONTRAINDICATIONS and PRECAUTIONS).
The ACIP has stated that "patients with leukemia in remission who have not received chemotherapy for at least 3 months may receive live-virus vaccines. Short-term ( < 2 weeks), low- to moderate-dose systemic corticosteroid therapy, topical steroid therapy (e.g., nasal, skin), long-term alternate-day treatment with low to moderate doses of short-acting systemic steroid, and intra-articular, bursal, or tendon injection of corticosteroids are not immunosuppressive in their usual doses and do not contraindicate the administration of rubella vaccine."22
Administration of immune globulins concurrently with MERUVAX (rubella virus vaccine live) II may interfere with the expected immune response.22,30
See also PRECAUTIONS, General.
7. Unpublished data from the files of Merck Research Laboratories.
31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.
36. Gershon, A.; et al: Live attenuated rubella virus vaccine: comparison of responses to HPV-77-DE5 and RA 27/3 strains, Am. J. Med. Sci. 279(2): 95-97, 1980.
37. Weibel, R.E.; et al: Clinical and laboratory studies of live attenuated RA 27/3 and HPV-77-DE rubella virus vaccines, Proc. Soc. Exp. Biol. Med. 165: 44-49, 1980.
38. Peltola, H.; et al: The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two dose vaccination program. N. Engl. J. Med. 331: 1397-1402, 1994.
Read the Meruvax Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/20/2008
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