Men and HPV vaccine (continued)
HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection. Gardasil was the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to the HPV in females. However, it turns out, Gardasil is nearly 90 percent effective for preventing HPV-caused genital warts in boys and men.
Gardasil is given in a series of three intramuscular injections over a six-month period in the shoulder region of the upper arm or in the front side of the upper thigh. The second and third doses should be given at two and six months after the first dose. It is not yet known how much protection patients would get from receiving only one or two doses of the vaccine. As a result, it is imperative that patients receive all three doses.
SAFETY CHECKS
Many patients are concerned with the safety of Gardasil. In order to monitor its safety, as well as all other vaccines, the FDA and the Centers for Disease Control and Prevention designed various systems. The first is the Vaccine Adverse Event Reporting System ("VAERS"), which receives unconfirmed reports of possible side effects following the use of Gardasil and all vaccines licensed in the U.S.
VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects). Secondly, the CDC has the Vaccine Safety Datalink (VSD) Project, which is a collaborative effort between the CDC and eight managed-care organizations that monitor vaccine safety and address the gaps in scientific knowledge about rare and serious side effects following immunization.
Next, the Clinical Immunization Safety Assessment Network collaborates with six academic centers in the U.S. to conduct clinical research on vaccine-associated adverse events. Lastly, vaccines are manufactured in batches called lots. All vaccine lots are routinely tested and must pass all tests before they can be used and vaccine manufactures must comply with strict manufacturing standards. The FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.
With that in mind, Gardasil does not appear to cause any serious side effects. However, anyone who has ever had a life-threatening allergic reaction to yeast, to any other component of Gardasil, or to a previous dose of Gardasil should not get the vaccine. Additionally, the vaccine is not recommended for pregnant women.
Several mild problems may occur with Gardasil at the injection site: pain, redness, swelling, or itching. Additionally, the patient may have a mild (100 degree Fahrenheit) to a moderate (102 degree Fahrenheit) fever, a headache or nausea. These symptoms do not last long and go away on their own.
Life-threatening allergic reactions to vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccine. However, like all vaccines, Gardasil should be continued to be monitored for unusual or sever problems. If you have any of the following signs of a serious allergic reaction call your doctor right away: A high fever or behavior changes, such as difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness.
At least 50 percent of sexually active people will contract HPV at some time in their lives. HPV causes cervical cancer, precancerous genital lesions and genital warts. However, Gardasil was developed to prevent these diseases and the research has shown it does this without causing any serious side effects.
Therefore, the benefit of the vaccine clearly outweighs the detriment. To date, I have recommended this vaccine to all female patients who meet the above-discussed criteria. Similarly, now based upon the new FDA approval, I will also recommend it to my male patients who meet the above-discussed criteria.
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