Adult Immunization Guidelines from CDC Released

Pharmacology Watch

In this issue:Updated Immunization Guidelines from the CDC; Do antivirals have a role in the treatment of Bell's palsy? Topiramate is a promising treatment for alcohol dependence; and FDA Actions.

The Annals of Internal Medicine has published updated Adult Immunization Guidelines from the CDC as an early release article on their website dated October 18. Full guideline will be available in the November 20 print edition. The guideline has several important changes and updates.

The new herpes zoster vaccine is added to the guideline this year. The vaccine should be given routinely to all immunocompetent adults age 60 and older. It is not recommended for immunocompromised adults as it is a

live attenuated virus. The vaccine is given once in a lifetime, and does not require a booster.

The new human papilloma virus has also been added. The vaccine protects against 4 types of HPV, which causes 90% of genital warts and 70% of cervical cancers. It is recommended for women aged 11 to 26 years. It requires three doses given at zero, 2 and 6 months. It should not be given to pregnant women.

The new pertussis vaccine is coupled with diphtheria and tetanus to form Tdap (Adacel- Sanofi Pasteur). This is a 1-time, 1-dose vaccine that should be given to all adults age 64 or younger when they are scheduled for their next tetanus (Td) booster. Tetanus boosters should be given every 10 years, but the interval may be shortened to as little as two years for high-risk patients including postpartum women, close contact of infants younger than 12 months of age, and all healthcare workers with direct patient contact. It has not been tested in adults age 65 or older. This vaccine is different from the previously approved Tdap for adolescents aged 10 to 19 (Boostrix-GlaxoSmithKline).

There are now 15 indications for influenza vaccine. New indications include those who have difficultly handling respiratory secretions or have increased risk of aspiration. All women who are pregnant or will be pregnant during the flu season should be vaccinated. All healthcare workers should be vaccinated unless they have strong contraindications.

Hepatitis B vaccine recommendations have changed, and the vaccine is now recommended for all sexually active adults who are not in a long-term mutually monogamous relationship.

Because of several recent large-scale mumps outbreaks in this country, a mumps vaccine booster is now recommended for specific age groups, especially adults who work in healthcare settings. The standard is to give MMR, even if immunity exists for one or more of the components of MMR.

The pneumococcal vaccine recommendations remain the same. The vaccine should be given at age 65 unless the patient has specific risk factors, in which case it should be given to those younger than 65. A small subgroup of patients should be given a second booster. If the vaccine was initiated under age 65 for high-risk patients, a booster should be given at age 65 or five years after the initial vaccine. If the vaccine was initiated over age 65, a booster should only be given to immunocompromised patients after five years. The vaccine should not be given every five years (a common misconception). In fact, no one should receive more than two doses under any circumstances. There is even some evidence that more than two doses may be harmful and could potentially attenuate the immune response.

Antivirals and Bell's Palsy?

Do antivirals have a role in the treatment of Bell's palsy? This question has been debated for decades, with several small studies indicating a relationship between herpes simplex infections and facial paralysis. Despite this, treatment with acyclovir or valacyclovir has not been proven to be effective in treating Bell's palsy. Regardless, antivirals are frequently prescribed along with oral steroids. A new study confirms that steroids are useful, but antivirals are not. Nearly 500 patients with new onset of Bell's palsy were randomized to 10 days of treatment with prednisolone, acyclovir, both agents, or placebo. The primary outcome was recovery of facial function. At three months, the proportion to patients who had recovered facial function were 83.0% in the prednisolone group compared with 63.6% among patients who did not receive prednisolone (P < 0.001) and 71.2% in the acyclovir group as compared to 75.7% among patients who did not receive acyclovir (adjusted P = 0.50). After nine months, recovery was 94.4% for prednisolone and 81.6% for no prednisolone (P < 0.001) and 85.4% for acyclovir and 90.8% for no acyclovir (adjusted P = 0.10). For patients treated with both drugs, recovery was 79.7% at 3 months (P < 0.001) and 92.7% at nine months (P < 0.001). There were no serious adverse effects in either group. The authors conclude that early treatment with prednisolone significantly improves the chance of complete recovery, while there's no evidence of benefit with acyclovir alone or in combination with the steroid (NEJM. 2007; 357:1598-1607).

Topiramate Promising for Alcohol Treatment

Topiramate is a promising treatment for alcohol dependence according to a new study. The drug was shown to be effective in this role in a small study published in 2003. This new, larger multisite 14 week double-blind, randomized, placebo controlled trial enrolled 371 men and women age 18 to 65 years who were diagnosed with alcohol dependence. Up to 300 mg per day of topiramate was given to 183 participants while 188 were treated with placebo. Both groups were enrolled in a weekly compliance enhancement intervention program. The primary end point was self-reported percentage of heavy drinking days, while secondary outcomes included other self-reported drinking measures along with laboratory measures of alcohol consumption. Topiramate was more efficacious than placebo at reducing percentage of heavy drinking days from baseline to 14 weeks (mean difference 8.44%; 95% CI, 3.07%-13 .80%; P = .002). Topiramate also reduced all of the drinking outcomes (P <.001 for all comparisons adverse events were more common with topiramate including paresthesia occurred in over of those on the drug taste perversion anorexia and difficulty concentration. general however was safe consistently efficacious treating alcohol dependence>AMA. 2007;298:1641-1651). An accompanying editorial points out that the benefits of topiramate were still increasing at the end of the study, indicating the longer treatment may be more effective (JAMA. 2007;298:1691-1692).

FDA Actions

The FDA has announced new warnings on phosphodiesterase type 5 inhibitors regarding hearing loss. The drugs include sildenafil (Viagra, Revatio), tadalafil (Cialis) and vardenafil (Levitra). The agency has received 29 cases of sudden hearing loss associated with use of the drugs dating back to 1996. Most cases were unilateral and temporary.

Modafinil (Provigil) has also been the subject of new warnings including serous rashes and psychiatric symptoms. The drug, which is used for narcolepsy, obstructive sleep apnea, shiftwork disorder, and multiple sclerosis, has been associated with severe rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. The FDA suggested caution should be exercised when modafinil is given to patients with a history of psychosis, depression, or mania.

An FDA advisory panel has recommended restricting childhood cold medications to children over the age of six years. They also recommend strong limits on marketing these products for younger children. This follows a voluntary withdrawal from the market of infant cough and cold medications by most manufacturers of these products. Voluntary withdrawal involves medications used in children younger than two years. The drugs that contain decongestants and antihistamines have been associated with more than one hundred deaths since 1969.

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: