FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

FDA News

FOR IMMEDIATE RELEASE
September 12, 2008

Media Inquiries:
Karen Riley, 301-827-6242
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The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.

“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

HPV includes more than 100 related viruses and more than 30 types can be transmitted via sexual contact. According to the U.S. Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States with 6.2 million Americans becoming infected with genital HPV each year.

For most women, the body’s own defense system will clear HPV, thereby preventing serious health problems. However, some HPV types can cause abnormal cell growth in areas of the cervix, vagina, vulva, and other areas that years later may turn into cancer.

Regarding the prevention of vulvar and vaginal cancer, Gardasil’s manufacturer, Merck & Co. Inc., followed more than 15,000 participants from the original studies for about two additional years. Approximately half had received Gardasil as part of the original study—the other half did not receive Gardasil and served as a control group.

Among females who tested negative for HPV types 16 or 18 at the start of the study, Gardasil was highly effective in preventing these types of HPV-related precancerous vulvar and vaginal lesions, which are considered to be the precursors for cancer. In the control group that did not receive the vaccine, 10 individuals developed precancerous vulvar lesions and nine developed precancerous vaginal lesions, all related to HPV types 16 or 18. No one in the Gardasil group developed either kind of precancerous lesion due to HPV types 16 or 18.

There was no evidence for benefit among women found to have been previously infected, prior to immunization, with the HPV types included in the vaccine. Therefore, to receive Gardasil’s full potential for benefit, it is important to be vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Gardasil’s label has been revised to note that presently available information is insufficient to support use beyond age 26, the current FDA-approved age. Also, new information has been added showing that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.

No vaccine is 100 percent effective, and Gardasil does not protect against HPV infections that a woman may already have at the time of vaccination. Therefore, all women should get regular Pap tests, even after they have been vaccinated. Routine Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

Since the FDA approved Gardasil in 2006, the majority of reported adverse events have not been serious. The most commonly reported adverse events have included syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

As part of the original approval, Merck committed to a safety surveillance study of 44,000 individuals in a managed care organization. The study is assessing short- and long-term safety for all of Gardasil’s approved uses.

As with all vaccines, the FDA and the CDC continue to closely monitor Gardasil’s safety. Updated safety information on Gardasil was published on July 22 and can be found at www.fda.gov/cber/safety/gardasil071408.htm.

Product approval information for Gardasil can be found at www.fda.gov/cber/products/gardasil.htm.
Merck & Co. Inc. is located in Whitehouse Station, N.J.

Wellbutrin (Bupropion HCL) and Thoughts of Suicide

Wellbutrin and other brands, whose chemical name is Bupropion Hydrochloride, have been linked to having ideas or thoughts related to suicide.

FDA ALERT [7/2005] – Suicidal Thoughts or Actions in Children and Adults

Text from FDA article:

Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.

Children

Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although bupropion is prescribed for children, FDA has not approved bupropion for use in children.

Adults

Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

The issues described have been addressed in product labeling. (The package insert that accompanies each bottle of the drug.)

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

More information is available at http://www.fda.gov/Cder/Drug/infopage/bupropion/

How I Quit Smoking After Twenty Years!




How I Quit Smoking

By Bob Diamond

I used to buy two or three packs of cigarettes every day. I smoked in elevators, in cars with the windows up and in airplanes when it was still legal. I would have a cigarette going in two or three ashtrays at once. I would re-inhale almost every puff. I would breathe a puff of smoke out slowly and breathe it back in through my nose for a second pass through my lungs. The last two knuckles on my forefinger and second finger on my right hand were stained an ugly yellowish-brown.

If I was in a bar I could have a cigarette in each hand and one burning in the ashtray on the table. I made it even worse for the people around me when I would smoke pipes and cigars while I was trying to quit cigarettes.

Until recently, my mother chain-smoked cigarettes. My father was a typical fat cigar-smoking traveling salesman. He would go through a box of fifty cigars almost every day. He would hand out one or two cigars to just about every customer or prospect that he came in contact with. He would use them as a conversation starter. He also used them as a tool for buying time while he was thinking of an answer to a tough question. He had a ritual of taking a cigar out, looking it over, rolling it in his fingers, smelling it, taking the wrapper off, smelling it again, lighting it with a flair; and then taking several prodigious puffs to get it fired up. By then he would usually have whatever answer he was looking for.

It was not unusual for someone at school or church to mention as I passed by, “Your father smokes cigars. Doesn’t he?” They could smell the cigar smoke on my clothes and on me.

I remember having empty Dutch Master cigar boxes all over the house. Anything that was worth keeping was kept in a cigar box.

When I was around fifteen years old some of my friends smoked because they thought it was cool. I had a couple of puffs now and then, but it didn’t stick. In high school I was a long-distance runner. I also played football and basketball. Smoking just wasn’t an issue.

Where I got into trouble was in college and then in Vietnam. You know the college thing — sitting around eating pizza in a local hangout and watching everyone else smoke. You bum a cigarette and the rest is history. Drinking beer requires the attendant ubiquitous cigarette. The same thing happened in Vietnam. We would sit around the barracks at night drinking beer, playing poker and smoking cigarettes.



By the time I got home from Vietnam I was a confirmed smoker. I went back to college and finished my pharmacy degree. Whenever I was in a situation where I couldn’t smoke, I wouldn’t. But I would make up for it later that night. I always ended up at the end of the day with my full quota of smokes.

After my first son was born, I quit smoking for about a year. I didn’t want to subject him to all of the crud in the cigarette smoke. I did all right until my brother-in-law came home from Vietnam also. He would come over to my house just about every night. He had a lot of things to get out of his system. He had been the door gunner on a helicopter. We would drink beer and talk about his experiences, etc. After a couple of weeks of that I bummed a cigarette. You know what that led to!

As a pharmacist I would see people every day with lung cancer, emphysema and all sorts of smoking related illnesses. It just didn’t register that I was susceptible also.

I admit that I am a control freak. I don’t like surprises. Everything has to be done at the right time and at the right place. The socks have to match the shirt. The belt and the shoes must match. You get the idea. I even tried hypnosis to quit smoking. The doctor said he couldn’t put me under because I wouldn’t relinquish control to him.

A patient of mine, who knew that I was a control freak, because she was one also, asked me why I smoked. She mentioned that she considered it to be a control issue, that the cigarettes were controlling me, not the other way around.

That did it! I looked at that little cigarette in my hand. I realized for the first time who was in charge. That damned little cigarette that wasn’t any bigger than my “pinkie” finger was running my life and ruining my health. I tore up the pack that was in my pocket, just as I had done several times before. Only, this time, I knew it was for good. All the other times that I had tried to quit I had tried to quit for other people. This time I was quitting for me. I was not going to let that little sucker run my life any more!

About twelve hours later, I realized that this was it. I struggled a little once in a while when I would walk through someone else’s puff of smoke. I realized that I missed smoking, but I was not going to let it take over again. That was twenty-five years ago. The smell of cigarettes actually makes me sick now. I even choke when someone smokes next to me outdoors. I don’t complain, because I used to do that to other people.

If you are a smoker, who do you think is in charge, you or your cigarette?

I hope the answer to that question helps you as much as it did me. Realizing that that little cigarette was running my life helped me to end my eight-year quest to quit smoking.

I want you to be in charge!

 

My Colon (Colorectal) Cancer Screening Day!

My Colon (Colorectal) Cancer Screening Day!

I’m going in for a colonoscopy today. I don’t have any symptoms or problems that I am aware of.

My mother had colorectal cancer so I have to be careful, since it has already occurred in my family.

Colon and Rectal Cancer

Beginning at age 50, both men and women at average risk for developing colorectal cancer should use one of the screening tests below. The tests that are designed to find both early cancer and polyps are preferred if these tests are available to you and you are willing to have one of these more invasive tests. Talk to your doctor about which test is best for you.

Tests that find polyps and cancer

  • Flexible sigmoidoscopy every 5 years*
  • Colonoscopy every 10 years
  • Double contrast barium enema every 5 years*
  • CT colonography (virtual colonoscopy) every 5 years*

Tests that mainly find cancer

  • Fecal occult blood test (FOBT) every year*, **
  • Fecal immunochemical test (FIT) every year*, **
  • Stool DNA test (sDNA), interval uncertain*

*Colonoscopy should be done if test results are positive.

**For FOBT or FIT used as a screening test, the take-home multiple sample method should be used. A FOBT or FIT done during a digital rectal exam in the doctor’s office is not adequate for screening.

People should talk to their doctor about starting colorectal cancer screening earlier and/or being screened more often if they have any of the following colorectal cancer risk factors:

  • A personal history of colorectal cancer or adenomatous polyps
  • A personal history of chronic inflammatory bowel disease (Crohns disease or ulcerative colitis)
  • A strong family history of colorectal cancer or polyps (cancer or polyps in a first-degree relative [parent, sibling, or child] younger than 60 or in 2 or more first-degree relatives of any age)
  • A known family history of hereditary colorectal cancer syndromes such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC)

I hope this article, and my willingness to be screened, will help you to make the possibly life saving decision to get yourself screened soon.

I have the results of my colonoscopy. I had one non-cancerous polyp removed. That polyp could have caused cancer down the road if it had been left there.

My story has a happy ending.

Now it’s your turn to be checked.

Bob Diamond R.Ph

http://www.bobthepharmacist.com


* The American Cancer Society was the source for most of the information in this article.

http://www.cancer.org/

Seasonal Affective Disorder (SAD) – MayoClinic.com

I have a good frend and a close relative who are affected by SAD. With fall quickly approaching, I thought this might be a timely topic.

Like many people, you may develop cabin fever during the winter months. Or you may find yourself eating more or sleeping more when the temperature drops and darkness falls earlier. While those are common and normal reactions to the changing seasons, people with seasonal affective disorder (SAD) experience a much more serious reaction when summer shifts to fall and on to winter.

With seasonal affective disorder, fall’s short days and long nights may trigger feelings of depression, lethargy, fatigue and other problems. Don’t brush this off as simply a case of the “winter blues” that you have to tough out on your own…

Click on the link belown to see the full article…

Seasonal Affective Disorder (SAD) – MayoClinic.com


Have you used tobacco in any form, now or in the past?

Taking Care of Yourself

If you have used tobacco in any form, now or in the past, tell your health care provider so he or she can be sure that you have right preventive health care.

It is well known that smoking puts you at risk for certain health-related illnesses. This means part of your health care should focus on related screening and preventive measures to help you stay as healthy as possible.

For example, you will want to regularly check the inside of your mouth for any changes and have an oral exam by your doctor or dentist if you do find any changes or problems.

The American Cancer Society recommends that periodic check-ups should include oral cavity (mouth) exams. By doing this tobacco users may be able to find oral changes and leukoplakia (white patches on the mouth membranes) early. This may help prevent oral cancer.

You should also be aware of any of the following:

  • any change in a cough (for example, you cough up more phlegm than usual)
  • a new cough
  • coughing up blood
  • hoarseness
  • trouble breathing
  • wheezing
  • headaches
  • chest pain
  • loss of appetite
  • weight loss
  • general fatigue (feeling tired all the time)
  • repeated respiratory infections

Any of these could be signs of lung cancer or a number of other lung conditions and you should report any symptom to your doctor. Although these can be signs of a problem, many lung cancers do not cause any noticeable symptoms until they are advanced and have spread to other parts of the body.

If you have any health concerns that you think may be related to your cigarette smoking, please see your health care provider as quickly as possible.

Taking care of yourself and getting treatment for small problems will give you the best chance for successful treatment. The best way, though, to take care of yourself and decrease your risk for life-threatening lung problems is to quit smoking.

http://www.cancer.org/docroot/PED/content/PED_10_13X_Guide_for_Quitting_Smoking.asp

Use Your Pharmacist!

Your Pharmacy Resource

The pharmacist can be a valuable source of health information that can be used more by patients and caregivers.  When the check-out clerk in the pharmacy asks you “Do you have any questions for the pharmacist?”, do not hesitate to say “yes” and then ask for the pharmacist.

What to Tell the Pharmacist

For many the pharmcist will be the last health care provider that patients and caregivers will talk to before heading home.

Some of the important things that you should tell the pharmcist include:

Your allergies.

All the medications you are taking.  This includes more than prescription drugs.  It also includes over-the-counter medicines and herbal supplements.

What to Ask the Pharmacist

If the doctor did not fully answer all questions, the pharmacist can be a good source of health information.

Here are some key questions to ask the pharmacist.

Ask the pharmacist how you should be taking the medicine.

Ask what is the best time to take them and if they should be taken with or without food.

Ask the pharmacist about possible side effects and how they should be handled.

You have every right to know about your medical conditions and the medications you are taking.  A caregiver should expect to have the same information so they can do their job properly.  You should ask the pharmacist about any questions or concerns that you might have.  Even though pharmcists are busy, answering questions is our job.

Most pharmacists will admit that helping patients is the most rewarding part of their job.

Complications of Diabetes

Heart and Blood Vessel Disease

Heart disease is the leading cause of death for people with diabetes.Three out of four diabetes-related deaths are caused by heart and blood vessel (cardiovascular) disease. People with diabetes are 2-4 times more likely to have heart disease than persons without diabetes. Even people with type 2 diabetes who do not have heart disease have an increased risk of having a heart attack.

People with diabetes also tend to have other risk factors for heart disease including obesity, high blood pressure, and hardening of the arteries (atherosclerosis).In recent years, FDA has approved drugs that lower blood pressure and reduce the risk of heart attacks and strokes. It has also approved lipid-altering drugs that target abnormalities of cholesterol and triglycerides.

For more information about diabetes and heart disease, click on this link: HEART DISEASE AND HIGH BLOOD PRESSURE

National Heart, Lung, and Blood Institute link: CARDIOVASCULAR INFORMATION

Practical Medicine and Healthcare Information

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I have been a community and hospital pharmacist for over thirty years … trained in clinical pharmacy at one of the largest healthcare centers in the South. I am a consultant pharmacist for Medication Therapy Management (MTM) for the State of North Carolina.

I search the Internet and other sources for information that I think you should be aware of; that should be interesting and important for you to know. When I see something that meets these criteria, I will let you know about it in my next article.

If you don’t see some information that you need and it is within my areas of education and expertise, I will try to post an article or an answer as soon as possible! You can put your request in the “Contact Us” area located above the upper left column on this page.

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Bob Diamond R.Ph Pharmacist