FDA Warns About Misuse Of Fentora Cancer Pain Drug

fentanyl buccalThe US Food and Drug Administration (FDA) has issued a warning, alerting health professionals and patients about the potential misuse and side effects of Fentora (fentanyl buccal), a tablet-based drug that is approved only for the treatment of breakthrough pain in people with cancer.

There have been recent reports of deaths and adverse side effects in connection with the drug, which is made by drug company Cephalon Inc.

This follows the news earlier this month that the company sent letters to doctors and other health professionals about the reported adverse events and deaths.

The agency has asked the company to strengthen product warnings, make the dosing instructions clearer, and improve educational programmes and materials so that prescribers and pharmacists are better informed about patient selection, dosing and restrictions, particularly on substituting Fentora for other drugs.

Fentora is a powerful opioid and is only used for cancer patients who have become tolerant to opioids during treatment for breakthrough pain.

Breakthrough pain is an intense increase in pain that can come on suddenly and occurs even when opioid pain control is already being administered.

Patients who are on narcotic pain drugs 24/7 become tolerant and resistant to the dangerous side effects compared to patients on a less intense and frequent dose.

According to the FDA, who are continuing to investigate the events, the fatal events linked to Fentora use were the results of improper patient selection or substitution of the drug. Dr Steven Galson, director of the FDA’s Center for Drug Evaluation and Research said in a statement that the FDA was monitoring this very closely and:

“We are working with the manufacturer to ensure the safest use of this medicine.”

“Health care professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora,” cautioned Galson.

The FDA has issued a Public Health Advisory and Health Care Professional Sheet, in which the agency warns physicians and other health care professionals of the critical importance of observing the product label information when administering Fentora.

The agency warned it is dangerous to use Fentora for any pain of a short term nature such as headaches or migraines. And, it is critical that patients who are not opioid tolerant, do not receive Fentora.

Administration of Fentora should be accompanied by supervision and continuous monitoring under a doctor, so that the dose is carefully adjusted for controlling the breakthrough pain for a particular patient.

The FDA is also concerned about improper substitution of Fentora for other medications.

It is not the same as other fentanyl drugs said the agency, and cannot replace for example the drug Actiq, another fentanyl product that is also used for breakthrough cancer pain. This is because Fentora has a stronger effect, it delivers more fentanyl to the blood than Actiq, and so giving it instead of Actiq (for instance using the same dose) could lead to a fatal overdose.

The FDA has a voluntary programme for reporting adverse events related to approved drugs, called MedWatch.

Click here for MedWatch.

Click here for FDA information on: Fentanyl Buccal Tablets (marketed as Fentora).


Risk of cervical cancer distorted, causes alarm

Special to the Star
The recent headlines and political posturing about the HPV vaccine program to protect girls from cervical cancer might imply that there’s an epidemic of this type of cancer.

But that’s not the case, according to statistics and experts on both sides of the controversy.

At about 1,350 cases and 400 deaths a year, cervical cancer rates 13th on the list of cancers most frequently suffered by women, based on Canadian Cancer Society statistics for 2007.

That’s way behind breast cancer, at 22,300 cases and 5,300 deaths, lung cancer, at 10,900 cases and 8,900 deaths, and cancer of the pancreas, with 1,850 cases – all fatal.

“It’s not an epidemic because we have a relatively good screening program (Pap tests),” says Dr. Joan Murphy, head of gynecologic oncology at Princess Margaret Hospital and chair of the Society of Gynecologic Oncologists of Canada.

“All the hype is causing people to be worked up and needlessly worried,” says Anne Rochon Ford, co-ordinator for Women and Health Protection, a national working group that monitors drug regulation at Health Canada. “There was no crisis, so why did we have to rush ahead (with the vaccine program)?”

“We need some balance here,” agrees Dr. Abby Lippman, at epidemiologist at McGill University who has been outspoken against Ottawa’s support for the vaccine program.

But Murphy supports the vaccine program because she says “there is an epidemic of HPV” (human papillomavirus). As many as 80 per cent of Canadian women contract the virus each year, although the immune systems of 80 per cent of those who contract it manage to fight it off, she says.

There are 30 strains of HPV and the Gardasil vaccine can prevent HPV types 16 and 18, which are responsible for 70 per cent of cervical cancer cases, says Murphy.

All three women stress that the vaccination program is not a substitute for regular Pap tests, which help detect cervical cancer and other conditions.

In a Pap test, cells are scraped from the cervix and examined under a microscope.

“We need to educate young girls who have been vaccinated that they are still at risk. Pap tests remain vital,” says Lippman.

The Canadian Cancer Society has been advocating for the vaccine, which costs about $400 for the three-shot treatment, to be made more available and affordable since its approval by Health Canada in July 2006, says society spokesperson Heather Chappell.

The society supports the Ontario government’s decision to make the vaccine available to Grade 8 girls, and is now advocating for funding and surveillance programs and more followup, says Chappell.

“We need to keep track of who has received the vaccine so that we get a clearer picture,” she says.

Although records are kept on the number of cases of cervical cancer, there is little data on pre-cancerous conditions such as dysplasia, which is not cancer but may develop into cancer if it is not treated.

The vaccine can be effective against dysplasia, which requires painful treatments, says Chappell.

“So cervical cancer is not the whole story,” she says.

More Evidence Links Naproxen to Heart Dangers

November 21, 2006

The popular painkiller Naproxen has been linked once again to an increased risk of heart attack and stroke by researchers examining the safety of various headache and arthritis drugs.

Naproxen belongs to a class of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), which have come under scrutiny lately. Several studies have linked NSAIDs to increased heart risks, prompting the U.S. Food and Drug Administration to order that the drugs carry a heightened warning label.

The Painkiller Problem

Another class of painkillers called COX-2 inhibitors which includes drugs like Vioxx and Celebrex has also been the subject of recent safety debate. Various studies have shown that these drugs may cause heart attack and stroke. Consequently, makers of these drugs are currently facing thousands of liability lawsuits.

Researchers at the Johns Hopkins University School of Public Health recently conducted a study involving 2,500 elderly participants who were given Celebrex, naproxen, or a placebo for 3.5 years to sort out the risks associated with popular painkillers.

The research came to an abrupt end when concerns began to mount over the safety of COX-2 inhibitors. Still, researchers say the findings are worth noting.

Particularly for safety data, truth’ may come in small doses. We firmly believe that results from trials should be published regardless of the direction, magnitude, or statistical significance of the observed results, said researcher Barbara Martin.

The Findings

According to the results, 8.25 percent of the patients taking naproxen for more than three years experienced a serious cardiac event or death compared with 5.5 percent of those receiving Celebrex and 5.6 percent a placebo.

Experts, however, are cautioning against reading too much into these results. We don’t have the full answers, said Dr. Steven Nissen of the Cleveland Clinic in Ohio, adding that a large safety trial comparing naproxen, Celebrex, and placebo is currently underway.

Combined Asthma Medications Increase Negative Side Effects

August 24, 2006

Doctors at the University of Iowa who specialize in the treatment of asthma have issued a renewed warning about asthma medications like Advair, which combine salmeterol with a steroid.

According to the warning, a small subgroup of patients are susceptible to suffer severe, even fatal, side effects as a consequence of using combined asthma medications. In a letter to the New England Journal of Medicine , the doctors cited two example cases.

Two patients who had used asthma medications that combined salmeterol with a corticosteroid suffered life-threatening medical problems that were not brought under control until their asthma medication was switched.

Advair is a widely prescribed asthma drug, effective in the treatment of sudden asthma attacks. However, doctors warn against using asthma drugs like Advair regularly as a preventative measure.

FDA Report: ADHD drugs linked to 51 US Deaths

February 8 , 2006

A report released by the Food and Drug Administration (FDA) stated that regulators were prompted in 2004 to start monitoring cases of heart attacks, high blood pressure and other cardiovascular problems in patients taking widely prescribed drugs, Adderall and Ritalin. According to the FDA report, these potentially dangerous ADHA drugs may be responsible for the deaths of 51 Americans.

At this point, states the FDA, there is not conclusive information linking the prescription drugs to these fatalities.

“These reports themselves do not establish a causal relationship between these medications and cardiovascular adverse events,” wrote Dr. Gerald Dal Pan, director of the FDA’s Office of Drug Safety, in a notice on the agency website.

Controversy has long surrounded the use of ADHD drugs. Many doctors and parents argue that Ritalin and Adderall are widely over prescribed, particularly to children. Widespread abuse of these habit-forming medications is also a tremendous source of concern in the United States.

The FDA will hold an advisory panel meeting to discuss how to evaluate the possible drug side effects caused by ADHD medications. Scientists and experts will supply updated information at the meeting and their concerns regarding the serious health problems the ADHD drugs pose.

The FDA report revealed 24 deaths from 1999 through 2003 among U.S. Adderall users. Sixteen more deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs. Another 11 deaths among users of drugs other than Adderall in the amphetamine class were also reported.

At least 30 additional deaths have been recorded in connection to ADHD drugs, but involved cases outside the U.S. or ones that occurred after the review period.

Numerous death and injury reports prompted Health Canada to yank the ADHD drug Adderall from the market temporarily last year. However, the drug was available after six months after the agency was not able to prove that Adderall was more risky than other drugs.

“Conclusions about the relative safety of these two stimulant therapies cannot be made on the basis of this analysis,” the FDA said.

Adderall’s manufacturer, Shire Pharmaceuticals Group PIc, also claim they have no data linking Adderall and the sudden deaths reported among children. Spokesman Matthew Cabrey said the company supports the FDA’s current conclusions of the issue.

Novartis AG, makers of Ritalin, also found no correlation between the use of ADHD drugs and the increased risk of cardiovascular problems.

The FDA will continue to evaluate the risks that may be associated with these drugs as well as study if ADHD drugs may be related to psychiatric problems.

Adderall Abuse With Teens

July 6, 2007New findings show that more and more teens are using adderall, a drug prescribed to those with attention deficit disorder (ADD), for recreational use.

The drug has become popular with teens and college students nationwide who want to stay up all night in order to study and party.

Different Reactions for Various Users

According to Dr. Michael Boyle, the medical director of Henry Ford Health System Maplegrove, for those who have been properly diagnosed with ADD and take the medication as it has been prescribed, there is no risk of addiction.

However, for those who are not inflicted with ADD and take adderall to stay up all night, the side effects have been proven to be harmful.

Who Uses and Why?

“One in five college-age students misuses adderall,” claims Kathleen Altman from the Oakland County Health Division Substance Abuse office. “Since people who are not taking it with a prescription are using it in the party scene, it can give a high like cocaine and is often used with alcohol and other drugs.”

Boyle says that the drug is fairly easy to get for kids who simply go to their doctor’s or psychiatrist claiming they cannot concentrate and are not doing well in school, and oftentimes doctors will give them adderall without doing neuropsychological testing.

“Prescription drugs are harmful when taken on a long-term bases,” says Dr. Arnold Keller, executive director of Milestone Psychotherapy and Counseling Services in Northville. “Large doses can cause physiological deterioration, blotches on the face and skin rashes.”

(Source: The Oakland Press)

Acetaminophen Liver Risks

July 6, 2006A new study reveals that acetaminophen, commonly sold as Tylenol, when taken at the highest recommended dose, can cause blood test abnormalities that might indicate liver damage. These findings, published in the Journal of the American Medical Association yesterday, came as a surprise to researchers.

Previously, researchers noted the potential for liver toxicity in patients taking a combination of acetaminophen and painkiller hydrocodone. They assumed the liver risks stemmed from the opioid and not from the acetaminophen. After all, acetaminophen has been on the market for over 20 years and has an excellent safety record.

However, when experts at the University of North Carolina conducted further research they discovered that taking acetaminophen at the highest recommended dose can cause abnormalities in blood aminotransferase (ALT and AST) tests, which are designed to measure liver enzyme levels to detect liver damage.

In response to these findings about acetaminophen liver risks, some experts say the recommended dosing of this over-the-counter drug has been called into question. “They are showing what we thought was the upper limit of safety in people who are not regular drinkers or fasting is too high,” comments Dr. Eugene Schiff of the University of Miami.

While this new study should prompt additional research into the liver risks associated with acetaminophen, the authors of the study say it is unnecessary to stop using this drug when medically beneficial. Of course, no drug should be used when it is not necessary.

If you are concerned about acetaminophen liver risks, please contact your health care practitioner to learn more.