Pharmacology Watch
CDC Adds Shingles Vaccine to List for Adults 60 Plus
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In This Issue: Shingles vaccine added to CDC list of vaccines for adults 60 and older; CDC recommends Tdap for postpartum women; new study suggests sequential therapy with antibiotics for H. pylori may be more effective than standard therapy; FDA Actions.
The Centers for Disease Control and Prevention (CDC) have added shingles vaccine to the list of routine vaccines recommended for adults. Shingles vaccine (Zostavax) is recommended for adults 60 years of age or older even if they have a history of having shingles. The recommendation is based on data showing that the vaccine reduces the occurrence of shingles by 50% in those over the age 60. For the group age 60 to 69, the vaccine reduces the occurrence by 64%. Over 95% of adults have been infected by varicella-zoster virus during their lifetime, most developing chickenpox during childhood. After the acute infection the virus lies dormant in a nerve ganglion until it reactivates as shingles. Most children now receive varicella vaccine as part MMRV or individually with the chickenpox vaccine (Varivax). Shingles becomes more common over the age of 50 with as many as one third of the population developing shingles during their lifetime and one third of those may develop complications such as postherpetic neuralgia (PHN). The vaccine is also effective at preventing PHN (66% reduction). If the vaccine is given to older adults, it is more likely the virus will attenuate the severity of shingles rather than preventing shingles itself. In those older than 80, efficacy of preventing shingles was only 18%; however, there was still efficacy at preventing PHN (39% reduction). A comprehensive of review of this topic may be found at MMWR web site www.cdc.gov/mmwr.
Pertussis, Tetanus, and Diphtheria Vaccines for Pregnant Women
The CDC through their Advisory Committee on Immunization Practices has also issued new recommendations for the pertussis, tetanus, and diphtheria vaccine for women during and after pregnancy. Mothers are an identified source of pertussis infections in infants where the rates for complications and fatalities are the highest. Women who have not received the tetanus, reduced diphtheria, and acellular pertussis (Tdap[Adacel]) vaccine previously should be vaccinated postpartum before they leave the hospital or soon as possible after discharge. They may receive it as soon as two years after their most recent diphtheria and tetanus (Td) vaccination. They can also receive diphtheria tetanus vaccination during pregnancy if needed or defer it to receive the Tdap immediately postpartum. Currently the Tdap vaccine is not recommended during pregnancy although health-care providers "should weigh the theoretical risks and benefits before choosing to administer Tdap vaccine to pregnant women." The full text of the CDC's recommendations can also be found online at www.cdc.gov/mmwr.
Standard therapy for eradicating H. pylori infections fails in up to one quarter of patients. A new study published online as an early release article in The Annals of Internal Medicine suggests that sequential therapy with antibiotics may be more effective than standard therapy which generally consists of triple drug regimens including a proton pump inhibitor and clarithromycin with either amoxicillin or a imidazole for 7 to 14 days. In a meta-analysis of 10 randomized controlled trials involving 2747 patients, eradication rates were 93.4% for sequential therapy (95% CI, 91.3%-95.5%) and 76.9% for standard triple therapy (CI, 71.0%-82.8%). Sequential therapy is more complicated for the patient, involving five days of a proton pump inhibitor with an antibiotic followed by five days of a proton pump inhibitor with two other antibiotics. The median rates of adherence were 97.4% for sequential therapy and 96.8% for standard therapy. Both treatments had similar side effect profiles. The authors state that most of the studies were conducted in Italy and there was evidence of publication bias. Despite this they conclude that 10-day sequential therapy appears superior to standard triple therapy for eradication of H. pylori infection (published early release Ann Int Med. 20th May 2008, print 17 June 2008).
FDA actions
The FDA has proposed broad new labeling requirements for prescription drugs regarding their use during pregnancy and breast-feeding. This labeling information is directed at physicians and other health-care professionals. The new labeling would eliminate the letter categories from the pregnancy section of prescription labeling. The new format would include sections called "Fetal Risk Summary" which would describe what is known about the effects of the drug on the fetus and the strength of the data. This section would be required to include "risk conclusions" for the possibility of fetal harm based on available data. Another section, called "Clinical Considerations" would include information about the effects of the drug if it is taken prior to pregnancy as well as information on the risk of the disease being treated to the mother and baby. The third section under the heading "Data" would describe details regarding data on use of the drug in humans and animals that were used to develop the Fetal Risk Summary. The section on lactation is similar in format as that for pregnancy. Newly approved drugs will need to follow this format while previously approved drugs will be phased in over time.
The FDA has approved lubiprostone for the treatment of the irritable bowel syndrome with constipation (IBS-C) in adult women aged 18 over. The drug was previously approved in 2006 for chronic idiopathic constipation. There is currently no prescription drug therapy available in this country for IBS-C after the withdrawal of Novartis' tegaserod (Zelnorm) last year. The safety and efficacy of lubiprostone was demonstrated in two studies involving 1154 patients of which 92% were women. The drug is not approved for use in men due to lack of data demonstrating efficacy. The dose is 8 µg twice a day orally with food and water. Lubiprostone is manufactured by Sucampo pharmaceuticals and will be jointly marketed Takeda Pharmaceuticals under the trade name "Amitiza."
The FDA is reminding health-care professionals and patients that HFA propelled albuterol inhalers will no longer be available in the United States after December 31, 2008. These inhalers contain chlorofluorocarbon (CFC)-propelled inhalants which are thought to harm the Earth's ozone layer. New inhalers use hydrofluroalkane (HFA) as a propellant, and three have already been approved by the FDA including ProAir HFA, Proventil HFA, and Ventolin HFA. In addition levalbuterol is available in an HFA formulation (Xopenex HFA). Some patients have complained about the HFA propellant, noting the spray has a softer feel. Patients must also prime and clean HFA-propelled albuterol inhalers to avoid build- up of medication in the device.
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5431. E-mail: [email protected].
Shingles vaccine added to CDC list of vaccines for adults 60 and older; CDC recommends Tdap for postpartum women; new study suggests sequential therapy with antibiotics for H. pylori may be more effective than standard therapy; FDA Actions.Subscribe Now for Access
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