What side effects are possible with Gardasil?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- a general feeling of discomfort or illness
- cough
- diarrhea
- dizziness
- fever
- joint pain
- nausea and vomiting
- pain, swelling, itching, or redness at the injection site
- stuffy nose
- toothache
- trouble sleeping
Check with your doctor as soon as possible if any of the following side effects occur:
- severe headache
- signs of an intestinal infection such as sudden and severe vomiting and diarrhea, fever, abdominal cramping, muscle aches, and headache
- signs of pelvic inflammatory disease such as pain during intercourse, lower abdominal pain, abnormal vaginal discharge which may be foul smelling, fever, irregular menstrual bleeding
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of appendicitis such as swelling and stiffness of the abdomen, pain on the right side of the abdomen when pressed on the left side
- signs of a severe allergic reaction such as itching, rash, hives, swelling of the face or lips, chest tightness, or shortness of breath
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for Gardasil?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Bleeding disorders: If you have any bleeding problems (such as hemophilia) or are taking blood thinners such as warfarin (Coumadin®), tell your doctor before receiving this medication.
Health exams: You will still need to have regular health exams after having the vaccine, including Pap tests, HPV DNA tests, or other tests as recommended by your doctor.
Immune system: People with weakened immune systems (e.g., those with cancer, HIV, or taking transplant medications) may not get the full benefits of the vaccine.
Vaccine protection: This vaccine protects only against certain types of HPV and should not be used for treatment of active genital warts or cervical and vaginal cancers. It does not prevent all types of HPV. It does not prevent any other sexually transmitted infections (STIs), such as chlamydia, gonorrhea, or HIV. Condoms should still be used to prevent STIs even after you have received the vaccine.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if human papillomavirus vaccine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication have not been established for children less than 9 years of age.
What other drugs could interact with Gardasil?
There may be an interaction between human papillomavirus vaccine and any of the following:
- medications that weaken the immune system (e.g., certain cancer medications, transplant medications)
- other vaccines (except for hepatitis B vaccine, which can safely be given at the same time as human papillomavirus vaccine as long as they are injected into different areas of the muscle)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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It is important to keep in mind that a compromised immune system, which increases a woman's risk of cervical cancer, can result from many things, including poverty and poor nutrition. Whether in North America or elsewhere in the world, women who die from cervical cancer are often poor. Efforts to eliminate cervical cancer require understanding and addressing this critical fact.
Some pharmaceutical companies and public health agencies are promoting the use of an HPV vaccine by all women, and by all girls beginning at age nine, as a way to eradicate cervical cancer. However, since Gardasil, the only approved vaccine, protects against the two types of HPV that are responsible for 70% of cervical cancers and not against types of the virus responsible for the other 30% of cervical cancers, "reduction" rather than "eradication" is a more accurate goal. Given this fact, proposals to make the vaccine mandatory may not reflect the best use of public health funds at this time.
Pap screening and HPV tests remain important tools in cervical cancer prevention and these tools still do not reach all the girls and women that they should. The HPV vaccine may also prove to be a useful tool, but we do not yet have the full story on its long-term safety, especially in young girls.
Until we know more about long-term safety and duration of effectiveness of the Gardasil HPV vaccine, as well as about how effective it actually is in reducing cervical cancer rates, health care dollars may be better spent in enhancing Pap screening programs (including Pap registries), and reaching the most marginalized populations (poor women, new immigrants, Aboriginal, rural and remote women) with Pap screening.
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http://en.wikipedia.org/wiki/
A recent opinion article by Abby Lippman PhD, Ryan Melnychuk PhD, Carolyn Shimmin BJ, and Madeline Boscoe RN DU published in the Canadian Medical Association Journal on August 1, 2007 argues that there remain a number of unanswered questions about the HPV vaccine, and that a universal vaccination program in Canada "is premature and could have unintended negative consequences." They also said "we must be certain that spending an estimated $2 billion to vaccinate a population of girls and women in Canada who are already mostly well protected by their own immune systems, safer sex practices and existing screening programs will not perpetuate the existing gaps in care and leave the actual rate of deaths from cervical cancer unchanged." [40]
http://en.wikipedia.org/wiki/
One unknown property of the vaccines now being researched is their longevity. Since the studies have been of short duration, it is unknown whether the vaccines will last just a few years or for much longer. Further study over time is required to answer this question.
270,000 women died of cervical cancer worldwide in 2002.[25] Acting FDA Administrator Dr. Andrew von Eschenbach said the vaccine will have "a dramatic effect" on the health of women around the world. [9] The American Cancer Society estimated that 9,700 women would develop cervical cancer in the United States in 2006, and 3,700 would die. [26]
Merck and CSL Limited are expected to market Gardasil as a cancer vaccine, rather than an STD vaccine. It remains unclear how widespread the use of the three-shot series will be, in part because of its $360 list price ($120 each for three shots). Merck and CSL have also suggested that governments make vaccination with Gardasil mandatory for school attendance, which has upset some conservative groups. [9] [27] Many such groups also expressed fears that vaccination with Gardasil might give girls a false sense of security regarding sex and increase their level of promiscuity. [28] [9] [29] There is no scientific evidence to prove this claim. Moreover, HPV is not transmitted solely through sexual contact, but may be transmitted via simple hand to hand contact. [30]
Health freedom organizations and other critics of the political power of pharmaceutical companies have vocally denounced the mandatory vaccination scheme as Merck's way of using forced drugging to pay for Vioxx lawsuits. [31]
Another potential issue is that it is not known whether this vaccine has any long-term adverse side effects. Although it has undergone full FDA trials, some fear that detrimental effects may not appear until years or decades after exposure.
- See also: vaccine controversy
Both men and women are carriers of HPV. To eradicate the disease, men will eventually need to be vaccinated. Studies are being conducted now to determine the efficacy of vaccinating boys with the current vaccine. [7]
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http://www.inciid.com/article.
For more information go to www.NVIC.org.
1. Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert. Table 6.
2. Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee: Gardasil HPV Quadrivalent Vaccine.
3. Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of betamyloid protein. Brain Res. Bull. 55, 211-217.
4. Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue. Pharmacol. Toxico. 70, 278-280.
5. Sahin G. et al. 1994. Determination of aluminum levels in the kidney, liver and brain of mice treated with aluminum hydroxide. Biol. Trace. Elem. Res. 1194 Apr-May;41 (1-2):129-35.
6. Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle. Brain, Vol 124, No. 9, 1821-1831.
7. Shingde M eta la. 2005. Macrophagic myofastitis associated with vaccine derived aluminum. MJA , 183 (03):145-146.
8. Merck & Co. May 18, 2006. Merck briefing document for Vaccines and Related Biological Products Advisory Committee: Gardasil. Table 24.
9. Merck & Co., Inc. 2006. Gardasil product insert: Serious Adverse Experiences.
10. Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee.: Gardasil. Table 32.
11. Food and Drug Administration. November 29, 2001. Vaccines and Related Biological Products Advisory Committee. Excerpt from transcript.
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http://thetyee.ca/News/2007/
Side effects?
In a separate clinical trial (of boys and girls aged nine to 15), Gardasil found that 82 per cent of vaccinated kids had adverse events including the onset of arthritis (compared to 67 per cent with the non-aluminum placebo), but researchers claim they weren't vaccine-related.
"The State [department of health] says Jessica's condition is not connected with the vaccine because the Gardasil website doesn't include it in the list of side effects [from trial participants]," says Vega, who had her daughter vaccinated because her own grandmother died of cervical cancer. "But what else can it be?" she wonders, saying that prior to the inoculation, Jessica had been a healthy, "super-athletic" teen who never even came down with colds. "She's staying really positive and taking this as a challenge," adds Vega who prefers not to comment on whether they'll pursue any legal action.
U.S.-based National Vaccine Information Center (NVIC), an advocacy group that calls itself "a leading critic of one-size-fits-all mass vaccination policies," red flagged the Gardasil vaccine before its FDA approval, stating it had " not proven safe for little girls." They cited Merck's monograph on adverse effects among vaccinated trial participants including two cases of rheumatoid arthritis and five cases of arthritis. They were especially concerned about long term effects among girls receiving both Gardasil and a hepatitis B vaccine.
Since the vaccine's approval, the group says it has tracked adverse events through a reporting system, starting with two 16-year-olds vaccinated within two weeks of FDA-approval who were eventually diagnosed with Guillain-Barré Syndrome.
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