Gardasil for Men (vs. Anal Cancer & Genital Warts): Side Effects & Safety

Gardasil for boys advised by US, Canada health authorities: Do you want to protect your son against genital warts? Or are you a sexually active male gay worried that you may get anal cancer?

If you are either, you might be glad to know that the use of Gardasil in males to protect against anal cancer, pre-cancerous lesions and genital warts was endorsed in January (2012) by Canada’s federally appointed panel of experts.

This follows the lead of its counterpart in the United States, the Advisory Committee on Immunization Practices that voted last fall to strongly recommend the use of HPV vaccines in boys and young men.

Hopefully, in both North American countries, we might see wider use of the HPV vaccines that have been recommended solely for girls and women until now.

In its statement, Canada’s National Advisory Committee on Immunization says that the evidence is strong that the vaccine protects males against a number of forms of cancer, pre-cancerous lesions and genital warts that are caused by the human papillomavirus.

It recommends the vaccine’s use in boys and young men nine to 26 years old. It also recommends it for males over the age of nine who have sex with other men. The vaccine isn’t licensed for use in either boys or girls under the age of nine.

The NACI recommendation is specific to Gardasil, the HPV vaccine that protects against four strains of human papillomavirus. Gardasil is produced by drug maker Merck.

The panel says it isn’t yet recommending the competing HPV vaccine, Cervarix, made by GlaxoSmithKline, as it’s still waiting for data proving the vaccine’s efficacy in males.

NACI says the evidence is strong that Gardasil prevents anal cancer, anogenital warts and pre-cancerous anal lesions. It said the evidence is good (Grade B) that the vaccine also protects against penile, perianal and perineal lesions and cancers.

The endorsement paves the way for public acceptance of Gardasil’s use in boys — but it’s no guarantee the vaccine will be added to the list of immunizations given to Canadian residents for free.

“A vaccine can be good and recommended and prevent disease but not be priority for new funding in health care.” explains Dr. Allison McGeer, an infectious diseases specialist and a former member of NACI.

The public cost can be significant: Gardasil is expensive and three doses are required. And the vaccine will be competing for funding with a combined vaccine to protect against measles, mumps, rubella and varicella (chickenpox), rotavirus vaccine and a nasal spray flu vaccine for children.

What you should know about Gardasil

To date, it’s the only vaccine that helps protect against the four types of HPV

In girls and young women 9 to 26 years old it helps protect against:
• two types of HPV that cause about 75 percent of cervical cancer cases
• two more types that cause 90 percent of genital warts cases
• 70% of vaginal cancer cases
• up to 50% of vulvar cancer cases

In boys and young men from nine to 26 years old it helps protect against:
• 90 percent of genital warts cases

It helps prevent against anal cancers in both boys/men and girls/women
You can’t get HPV or any disease caused by HPV from Gardasil.

The Gardasil vaccine contains no live virus. Instead, it contains a protein that helps the body’s immune system produce antibodies against HPV—without causing an infection.

Don’t take Gardasil if you have:
• an allergic reaction after getting a dose of GARDASIL.
• a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate 80

Tell your health care provider if you:
• are pregnant or planning to get pregnant. GARDASIL isn’t recommended for use in pregnant women.
• have immune problems, like HIV infection, cancer, or you take medicines that affect your immune system.
• have a fever over 100°F (37.8°C).
• had an allergic reaction to another dose of Gardasil.
• take any medicines, even those you can buy over the counter.

Common side effects
Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gardasil:

• dizziness
• headache
• mild fever
• mild pain
• redness
• itching
• bruising or swelling at the injection site
• nausea
• vomiting

Fainting can happen after getting Gardasil. Sometimes, people who faint can fall and hurt themselves. As a precaution, sit or lie down for 15 minutes after you get Gardasil.

Some people who faint might shake or become stiff. If this happens, your doctor will require an evaluation or treatment.

Other side effects:
Local: injection site pain, swelling, erythema and pruritus
Gastrointestinal: nausea, diarrhea, vomiting and toothache
General: fever, dizziness, malaise and insomnia. Postmarketing reports have included asthenia and fatigue.
Respiratory: cough, nasal congestion, nasopharyngitis and upper respiratory tract infection.
Musculoskeletal: myalgia and arthralgia

Tell your health care professional if any of the following problems occur because these may be signs of an allergic reaction or anaphylaxis:
• difficulty breathing
• wheezing (bronchospasm)
• hives
• rash

Tell your health care professional about:
• swollen glands (neck, armpit, or groin)
• joint pain
• unusual tiredness, weakness, or confusion
• chills
• generally feeling unwell
• leg pain
• shortness of breath
• chest pain
• aching muscles
• muscle weakness
• seizure
• bad stomach ache
• bleeding or bruising more easily than normal

Contact your health care professional right away if any of these symptoms concern you, even several months after getting the vaccine.

The U.S. Food and Drug Authority said this isn’t a complete list of side effects. You may report any side effects not listed in the drug’s warning box to the agency at 800-332-1088 or fill out the form here: https://www.accessdata.fda.gov/scripts/medwatch/

Clinical trials
A review of the clinical trials by Health Care Zone, showed that the FDA preferred to err on the side of caution.

For one, all participants of all clinical trials to test Gardasil’s safety and efficacy — both those who received Gardasil and those who received a placebo — complained of pain, swelling, erythema, pruritus and bruising.

Patients were given Gardasil reported these side effects at only 10 percent higher than those who received a placebo.

Both those given Gardasil and those given a placebo reported headaches and fever. As expected, those who received the actual vaccine reported these side effects at a higher rate—but only at a frequency one percent higher than those who received a placebo.

All in all, girls or women tended to report a higher rate of side effects—by at least 15 percent—than boys.

Before it was approved by the FDA, Gardasil was checked through six clinical trials among 14,273 girls, women, men and boys nine to 26 years old. The participants were divided into two, with 8,180 persons receiving Gardasil and 6,093 given a placebo, either one made of 4-Amorphous Aluminum Hydroxyphosphate Sulfate or a saline placebo.

As Gardasil is given in three doses, participants were given injections three times—either of Gardasil or a placebo on the day of enrollment, and about two and six after. Safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection.

Serious side effects
Across the clinical studies, 258 individuals out of 29,323 individuals reported a serious systemic adverse reaction—but this represented 0.8 percent of those who took the vaccine and one percent of those who took a placebo.

• Serious headache—0.02% Gardasil (three cases) vs. 0.02% AAHS control (two cases)
• Gastroenteritis—0.02% Gardasil (three cases) vs. 0.02% AAHS control (two cases)
• Appendicitis—0.03% Gardasil (five cases) vs. 0.01% AAHS control (one case)
• Pelvic inflammatory disease—0.02% Gardasil (three cases) vs. 0.03% AAHS control (four cases)
• Urinary tract infection—0.01% Gardasil (two cases) vs. 0.02% AAHS control (two cases)
• Pneumonia—0.01% Gardasil (two cases) vs. 0.02% AAHS control (two cases)
• Pyelonephritis—0.01% Gardasil (two cases) vs. 0.02% AAHS control (three cases)
• Pulmonary embolism—0.01% Gardasil (two cases) vs. 0.02% AAHS control (two cases)
• One case (0.006% Gardasil; 0.0% AAHS control or saline placebo) of bronchospasm
• Two cases (0.01% Gardasil; 0.0% AAHS control or saline placebo) of asthma
• One case of two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment)

Deaths
Out of all 29,323 participants who participated in the six clinical studies, 40 deaths were reported.
This represents 21 out of 15,706 who were given Gardasil and 19 out of 13,023 who received a placebo.

The most common cause of death was:
• motor vehicle accident (five persons who received Gardasil; four who received AAHS control)
• drug overdose/suicide (two individuals who received Gardasil; six individuals who received AAHS control)
• gunshot wound (one individual who received Gardasil; three individuals who received AAHS control) pulmonary embolus/deep vein thrombosis (one individual who received Gardasil and one individual who received AAHS control)
• sepsis (two cases)

Deaths were also due to one case each of: pancreatic cancer, arrhythmia, pulmonary tuberculosis, hyperthyroidism, post-operative pulmonary embolism and acute renal failure, traumatic brain injury/cardiac arrest, systemic lupus erythematosus, cerebrovascular accident, breast cancer, and nasopharyngeal cancer in the group that received Gardasil; asphyxia, acute lymphocytic leukemia, chemical poisoning, myocardial ischemia in the AAHS control group; medulloblastoma in the saline placebo group.

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