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Deaths Linked to Cephalon’s Cancer Pain Drug, Fentora

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After receiving reports of deaths and other serious side effects, FDA is alerting consumers and health care professionals to concerns about the use of Fentora (fentanyl buccal) tablets, a potent opioid pain medication.

Fentora is used only for treating breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it—those who take a regular, daily, around-the-clock narcotic pain medicine. Breakthrough pain is intense increases in pain that occur rapidly, even when opioid pain-control medication is being used.

People who develop tolerance to narcotic pain medicines are more resistant to the dangerous side effects of these medications than those who take narcotic pain medication less frequently.

The deaths reported indicate that some cancer patients

  • should not have been prescribed this medicine
  • were prescribed the wrong Fentora dose
  • took too many Fentora doses
  • received Fentora as a substitute for another fentanyl-containing product that is not equal to Fentora

Important Safety Information

  • Ask your doctor if you are opioid-tolerant before taking Fentora. The drug should only be used for breakthrough pain in opioid-tolerant patients with cancer.
  • Fentora should not be used to treat any type of short-term pain, including headaches or migraines, pain after an operation, or pain due to injury.
  • People who only take narcotic pain medications occasionally should not use Fentora.
  • Do not substitute Fentora for other fentanyl medicines, including Actiq. The dosage strength of fentanyl in Fentora is NOT equal to the same dosage strength of fentanyl in other fentanyl-containing products. Using the same dose can result in a fatal overdose.
  • Read the Medication Guide that comes with Fentora,and follow the directions exactly.

Watch For These Signs

Get medical attention right away if you have any of these signs:

  • trouble breathing or shallow breathing
  • tiredness, extreme sleepiness, or sedation
  • inability to think, talk, or walk normally
  • feeling faint, dizzy, or confused

FDA Actions

  • requested the manufacturer, Cephalon Inc., strengthen warnings and improve the dosing instructions in the drug’s product labeling and Medication Guide for patients
  • requested the company improve their education plan for prescribers and pharmacists
  • published a Public Health Advisory and Health Care Professional Sheet warning health care professionals that it is critical to follow Fentora’s product labeling
  • monitoring the Fentora issue closely and reviewing available information, including adverse events
  • working with the manufacturer to ensure the safest use of the medicine
  • providing updates as new information is available

Adverse events related to Fentora should be reported to MedWatch, the FDA’s voluntary reporting program.

Source: FDA

Tans Fade but Wrinkles are Forever – Slip, Slop, Slap

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Sun damages skin—period.
The obvious trick in summer is to balance exposure to sun with protection from the harmful rays that cause skin damage and can lead to cancer. These rays are known as UVA and UVB rays, with UV standing for Ultra Violet.

Australian health authorities, alarmed by the skyrocketing rise of minor skin cancers and deadly skin melanomas have instituted a health campaign with the tag line: SLIP (on a shirt), SLOP (on sunscreen), and SLAP (on a hat).

Lets briefly look at the elements of the campaign.
SLOP: Many people tend to confuse the terms "sunblock" and "sunscreen". Sunblock fully blocks the rays of the sun and consists of such "blocks" as titanium and zinc oxides. They are extremely effective in blocking sunlight, but they also are colored and leave the wearer appearing like a character on the canvas of "Women of Avignon" by Picasso. Furthermore, they need to be reapplied after only a few hours.

Two sunscreens that have hit the stores this year, Heliolex and Anthelios SX provide significant protection against UVA (80%) and UVB (90%) for up to five hours after application. Helioplex is sold by Neutrogena as UltraSheer. They go on easily, need to be reapplied less frequently than sunblocks, and are invisible.

SLIP: Nothing blocks the sun better than clothing, and when the sun is blazing, make sure you put a shirt on to protct your back and shoulders.

SLAP: You don’t have to look like a kangaroo hunter, but the more you can put your face in shadow, the less harmful rays your skin will accumulate.
And yes, you can get a fine tan with all of the above.
Drill this into your kids:

SLIP on a shirt
SLOP on sunscreen
SLAP on a hat

Mice Use Less Sunscreen – Substitute Coffee and Exercise Instead

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Who would have guessed that coffee and exercise induce the formation of cells that block sunrays? But they do–at least in mice.

As reported in the Proceedings of the National Academy of Science, hairless mice who were fed high doses of caffeine, and exercised on their running wheels, showed an increase in the cells which protect against sunburn.

There have been no human studies to date, so you may wish to continue your sunscreen, hats and shirts before switching to double espressos on the beach.

Source: Proceedings of the National Academy of Science, "Voluntary exercise together with oral caffeine markedly stimulates UVB light-induced apoptosis and decreases tissue fat in SKH-1"

Barbeque Grilled Food and Your Health

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You’ve been reading for years about the dangers lurking in grilled meats. But who doesn’t like to grill in the summer (or even the winter if the BBQ addiction is high enough).
So what do you do? How can you enjoy the simple pleasures of grilling without picturing yourself in a chemotherapy ward lamenting that last grilled steak?

The simplest solution (other than throwing the grill into the trash), is to not grill at high heats. High heats char the outside of the meat and increase the carcinogens. Cooking slower cuts down the exposure.

Additionally, cutting off the outside fat (particularly in lamb) cuts down the risk of flame-ups that burn the meat.
And it isn’t just meat. Anything with protein (fish, chicken, snake) can develop carcinogens on the grill.

Dieticians, such as Elizabeth Schaub at Baylor Medical Center point out that grilling vegetables and fruits is risk free.

Source: Baylor Health Care System

Decrease in Hormone Therapies Linked to Decline in Breast Cancer

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Researchers claim that an analysis of patients’ treatment records at a large HMO indicate that reduced use of hormone replacement therapy (HRT) may be the cause behind declining breast cancer rates.
They pointed out that, as some studies suggest, this decline is not due to reduced use of mammography.

The research indicates that one of the main causes of the decline is due to the reduction in post menopausal hormone therapy in 2003, in response to results of Women’s Health Initiative that linked breast cancer to hormone replacement therapy.

Growth of small tumors slows down when hormone replacement therapy is discontinued delaying discovery by almost two years. With the number of post menopausal estrogen and progestin prescriptions reduced to almost half, cancer rates have dropped by 7% in the year 2003.

Second Round High Dose Chemo May Cure Testicular Cancer

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Physicians from Indiana University report that increasing the dosage of anticancer drugs after the failure of first-line chemotherapy may lead to more succesful outcomes for men with testicular cancer.

The report published in the New England Journal of Medicine states that a considerable number of male patients with germ cell tumor are cured when they are treated with a second round of high dosage chemotherapy after the first round of chemotherapy has failed.

Unusual sensitivity of testicular cells to anticancer medicines is assumed to be behind these successful treatments. This treatment, however, cannot be extended to other types of cancers.

Low Cholesterol May Increase Cancer Risk

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According to a study in the Journal of the American College of Cardiology, use of cholesterol-lowering drugs or statins may increase the risk of developing cancer in patients.

Statins are commonly prescribed to heart patients because they help in lowering the level of cholesterol in blood.

During the analysis, 13 statin clinical trials were performed on 41,000 patients. The results indicated a higher rate of a newly-diagnosed cancer in low-cholesterol patients than high-cholesterol patients.

Although, in comparison to high cholesterol patients one additional case of cancer was found in low-cholesterol patients, researchers are still not sure about a direct link between statin use and increased cancer risk.

Tomatoes vs. Cancer, is the Evidence on Lycopene In?

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Sure it’s better to eat less fat, more vegetables and more tomatoes. But does the antioxidant lycopene prevent cancer?

A review published online by the Journal of the National Cancer Institute stated that their researches couldn’t find any scientifically sound evidence to support links between consuming antioxidants (food or supplements) and a statistically significant decrease in cancer of the prostate, lung, GI tract, breast or pancreas.

Source: New York Times (7/24/07)

Annual MRI Recommended for Some Women at Risk for Breast Cancer

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For some women who are at higher risk for breast cancer, the American Cancer Society’s has new guidelines that recommend those women get an MRI scan along with their annual mammogram.

While MRI’s are more sensitive and is likely to show more spots in the breast, it is often difficult to know if those spots are cancerous, and biopsy may be required. This is why the MRI is only recommended for high-risk women.

According to the American Cancer Society, an MRI screening in addition to mammograms is recommended for women who meet at least one of the following conditions:

  • they have a BRCA1 or BRCA2 mutation
  • they have a first-degree relative (parent, sibling, child) with a BRCA1 or BRCA2 mutation, even if they have yet to be tested themselves
  • their lifetime risk of breast cancer has been scored at 20%-25% or greater, based on one of several accepted risk assessment tools that look at family history and other factors
  • they had radiation to the chest between the ages of 10 and 30
  • they have Li-Fraumeni syndrome, Cowden syndrome, or Bannayan-Riley-Ruvalcaba syndrome, or may have one of these syndromes based on a history in a first-degree relative.

Asbestos in New York Steam Blast

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A steam pipe blast that injured dozens of people in downtown Manhattan spewed debris that contained asbestos particles, according to New York City’s Department of Emergency Management. The department says they found asbestos in six of ten samples taken.

"People who may (have come) into contact with the steam or debris should take a shower and place their clothes in plastic bags for cleaning or disposal," the statement said.

The blast resulted in dozens of injuries, and at least one death.

Asbestos is a very dangerous material that can cause a form of cancer called mesothelioma.

Most people who develop mesothelioma have worked on jobs where they inhaled asbestos particles, or have been exposed to asbestos dust by handling clothes of those who work in such an environment. Home renovation and demolition may also expose people to asbestos dust.