Popular Diabetes Drugs May Raise Pancreatic Cancer Risk, Study Suggests

AppId is over the quota
AppId is over the quota

THURSDAY, Sept. 22 (HealthDay News) -- People with type 2 diabetes taking the drugs Januvia or Byetta might have an increased risk of developing pancreatitis and pancreatic cancer, a preliminary study suggests.

The study also found that Byetta (exenatide) may raise the risk of thyroid cancer.

Although the links aren't conclusive, they merit further investigation, the researchers noted.

"We have raised concern that there may be a link, but we haven't confirmed it," said lead researcher Dr. Peter Butler, director of the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles. "We need to do more work to figure out whether this is real or not."

Both drugs help control blood sugar levels by encouraging production of a hormone called glucagon-like peptide 1 (GLP-1).

Januvia (sitagliptin) and Byetta, an injectable drug, are a new way of treating type 2 diabetes, and they potentially have advantages over older medications, Butler said. But, because these drugs are new, they're "the ones we know least about," he said. "When new drugs come out, the long-term side effects of these drugs are not well understood."

For the study, recently published in the journal Gastroenterology, Butler's team used 2004-2009 information in the U.S. Food and Drug Administration's database on adverse events, which are reported by doctors whose patients use these drugs.

When compared to other treatments, the researchers found a sixfold increase of reported cases of pancreatitis (inflammation of the pancreas) linked to patients taking Januvia or Byetta; a 2.9-fold increase in reported cases of pancreatic cancer among those taking Byetta and a 2.7-fold increase of reported pancreatic cancers among Januvia users.

In addition, they also noted an increase in reported cases of thyroid cancer with Byetta.

This latest study builds on earlier research, published in a 2009 issue of Diabetes, which found an increase in pancreatitis in rats whose GLP-1 levels were raised, the researchers said.

Butler is quick to point out that these increases in pancreatic cancer risk, while statistically significant, are not specifically related to patients, but rather to an increase in doctors reporting these cases to the FDA.

"It is important to avoid alarmism and have people stop medicines that they may be benefitting from when the risk is not yet defined," he stressed.

"If the drug and you are working well together, I wouldn't say there is any reason to stop the drug, based on the evidence we have right now," he said. "But if you have any concern you should talk to your doctor about it."

Being overweight is an important risk for both pancreatic cancer and type 2 diabetes, Butler noted. So the first advice to overweight patients with type 2 diabetes is to lose weight. "By doing that, you reduce the risk of pancreatic cancer," he said.

In addition, the first medication used to control blood sugar in type 2 diabetics is metformin, which by itself may reduce the risk for pancreatic cancer, Butler said. Metformin is an older drug with a well-known safety profile, he noted.

Dr. Mary Ann Banerji, director of the Diabetes Treatment Center at SUNY Health Science Center Brooklyn in New York City, said that "this is not perfect data."

However, Banerji does not prescribe these drugs for patients who have had a history of pancreatitis or a family history of thyroid cancer. There are alternatives such as metformin and insulin, as well as Avandia and Actos, she said, but studies have turned up an increased risk for heart attack and heart failure in the last two drugs. The FDA has removed Avandia from pharmacy shelves, and the agency issued a warning last summer that there is a possible increased risk of bladder cancer in patients who take Actos for more than a year.

The concerns about Januvia and Byetta "should not be blown out of proportion," Banerji said. "You prescribe them on an individual basis, because, in the end, all of medicine is individual," she said. "We should use these drugs judiciously along with metformin."

Industry representatives, insisting that no studies involving these drugs have found an increased risk of pancreatitis or pancreatic cancer, stand by their products. The database used for the study contains information on doctor-reported cases and does not reflect cause-and-effect, they said.

Dr. Barry Goldstein, vice president and therapeutic area head for diabetes and endocrinology at Merck Research Laboratories, which makes Januvia, said that "there has been no association shown between Januvia and pancreatitis."

"We have full confidence in Januvia, which is used by millions of patients around the world," he said.

Anne Erickson, a spokeswoman for Amylin Pharmaceuticals, makers of Byetta, said that "the conclusions of the study are in contrast to other nonclinical, clinical and adequately conducted post-marketing epidemiological studies."

Epidemiological studies have not established a significantly increased risk of pancreatitis associated with Byetta, she said. "To date, the available data do not demonstrate that exenatide increases the overall risk of cancer in humans."

Another expert, Dr. Ronald Goldberg, professor of medicine, biochemistry and molecular biology at the University of Miami Miller School of Medicine, said the findings merit consideration. "I don't think the study is definitive, but it raises a flag and is clearly something we need to pay attention to going forward."

There is "more benefit than risk with these drugs, based on our current knowledge," he said.

More information

For more information on diabetes, visit the U.S. National Library of Medicine.

SOURCES: Peter Butler, M.D., director, Larry L. Hillblom Islet Research Center, University of California, Los Angeles; Ronald Goldberg, M.D., professor of medicine, biochemistry and molecular biology, University of Miami Miller School of Medicine, Miami, Fla.; Mary Ann Banerji, M.D., professor of medicine, director, Diabetes Treatment Center, SUNY Health Science Center at Brooklyn, N.Y.; Barry Goldstein, M.D., Ph.D., Vice President and Therapeutic Area Head, Diabetes and Endocrinology, Merck Research Laboratories; Anne Erickson, spokeswoman, Amylin Pharmaceuticals; July 2011, Gastroenterology

Copyright © 2011 HealthDay. All rights reserved.

View the original article here

Peliculas Online

Experimental Drugs Do Battle Against Advanced Prostate Cancer

AppId is over the quota
AppId is over the quota

TUESDAY, Jan. 31 (HealthDay News) -- Two new drugs, taken alone or potentially together, may boost survival for men with advanced prostate cancer, studies suggest.

The results were so promising that both trials were stopped early to make sure all participants could benefit from the drugs.

Men enrolled in both studies had what's known as "metastatic castration-resistant prostate cancers" -- tumors that had continued to grow and spread despite standard treatment aimed at lowering testosterone levels. (The male hormone testosterone is thought to feed prostate cancer).

The data were presented in San Francisco on Tuesday as part of the Genitourinary Cancers Symposium, sponsored in part by the American Society of Clinical Oncology (ASCO).

According to ASCO, more than 241,000 men in the United States will be diagnosed with prostate cancer in 2012, and 28,000 men will die from the disease.

Prostate cancer often spreads to the bone, but one of the new drugs, called radium-223 chloride (Ra-223), improved survival and delayed cancer-related bone problems in men with advanced, spreading tumors, the researchers said. The first in a new class of prostate cancer medications, Ra-223 delivers bursts of radiation to the bone, targeting the tumor.

The study included 922 men with advanced prostate cancer that had spread to the bone. The men were randomly selected to receive either Ra-223 plus best supportive care or a placebo along with similar care. Supportive care was aimed at alleviating the symptoms of the cancer, including pain.

The new drug seemed to help, boosting survival to an average of 14 months compared with just over 11 months for those on the placebo. Additionally, the average time to the first bone-break, fracture or need for radiation or surgery was significantly delayed among men treated with the new drug compared to their counterparts who received placebo -- from 8.4 months without Ra-223 to 13.6 months with it. The treatment also appeared safe, the research team concluded.

"The U.S. Food and Drug Administration said it will fast track [this drug], and I don't think additional data will be required," study lead author Dr. Oliver Sartor, professor of cancer research at the Tulane University School of Medicine in New Orleans, said at a meeting press briefing. He said the hope is that this drug will be available to patients in 2012. Ra-223 is being developed by Algeta ASA and Bayer Healthcare. The study was funded by Algeta ASA.

In a second trial, another experimental medicine, called MDV3100, appeared to boost survival by close to five months among men with advanced prostate cancer. This drug works by preventing male sex hormones (such as testosterone) from binding to receptors on cancer cells (the tumor needs these hormones to survive and thrive).

In the study, close to 1,200 men received either MDV3100 or an inactive placebo. Median overall survival was 18.4 months for men treated with the experimental drug compared with 13.6 months for those receiving placebo.

The new drug also reduced the risk of death by 37 percent compared to placebo, the researchers said.

Side effects included fatigue, diarrhea and hot flushes, and were generally considered mild, lead author Dr. Howard Scher, chief of the genitourinary oncology service and chair of Urologic Oncology at Memorial Sloan-Kettering Cancer Center in New York City, said at the press briefing. This drug is being developed by Medivation and Astellas Pharma. The study was funded by Medivation.

"This is very impressive and unprecedented," added Dr. Nicholas Vogelzang, chair and medical director of the developmental therapeutics committee of U.S. Oncology, a research network specializing in cancer clinical trials. He moderated the press conference announcing the new study results. "This is going to change the way we take care of patients who we see in the office," he said.

The real gold may be in combining the two therapies, the experts theorized. "These drugs are going to be used in sequence and we would expect the survival to be fairly dramatically pushed forward," according to Scher. "There will be a major bump up in the overall survival of this group of patients in the next two to three years."

Vogelzang agreed: "The synergistic benefit will have to be demonstrated, but it is very plausible that combining and sequencing these agents may add even more value than what we see here." He was a co-investigator on the Ra-223 study.

Findings presented at medical meetings are typically considered preliminary until they have been published in a peer-reviewed journal.

More information

There's much more on prostate cancer at the American Cancer Society.

SOURCES: Howard I. Scher, M.D., chief, genitourinary oncology service, D. Wayne Calloway Chair in Urologic Oncology, Memorial Sloan-Kettering Cancer Center, New York City; Oliver Sartor, M.D., Laborde Professor of Cancer Research, Tulane University School of Medicine, medical director, Tulane Cancer Center, New Orleans; Nicholas J. Vogelzang, M.D., chair and medical director, developmental therapeutics committee of U.S. Oncology, Las Vegas; Jan. 31, 2012, presentations, Genitourinary Cancers Symposium, San Francisco

Copyright © 2012 HealthDay. All rights reserved.

View the original article here

Peliculas Online

FDA Moves to Head Off Shortages of 2 Cancer Drugs

IP is over the quota
IP is over the quota

TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have been in dangerously short supply.

One of the drugs, methotrexate, is used in combination with other drugs to combat -- and in many cases cure -- acute lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5.

And another drug, Lipodox, will be temporarily imported from a pharmaceutical company in India to ease a shortage of the chemotherapy drug Doxil (doxorubicin), which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Lipodox is similar in chemical makeup to Doxil; there are no generic versions of Doxil.

"Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," FDA Commissioner Dr. Margaret A. Hamburg said in a news release.

The FDA also said it was issuing guidelines to the drug industry that spell out detailed requirements for "both mandatory and voluntary notifications" to the agency of potential problems that could result in a drug shortage or supply disruption.

Methotrexate is a cornerstone in the treatment of children with acute lymphoblastic leukemia. In high doses, the generic drug has been successful in curing patients and beneficial in preventing recurrence. Without the drug, a patient's chance for a cure is reduced while the risk of recurrence rises, oncologists said.

Some cancer doctors had warned last week that supplies of methotrexate could be exhausted within two weeks.

To offset the shortage of methotrexate, the FDA said Tuesday that it has worked with several drug manufacturers to help maintain supplies to meet all patient needs. Preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of children with ALL, the agency said.

The FDA said the steps taken with methotrexate included approving a preservative-free version of the generic drug manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those supplies should become available in March and continue indefinitely, the agency said.

Second, Illinois-based Hospira Inc., which already manufactures methotrexate, has sped up additional supplies, producing 31,000 new vials of the drug -- enough for more than one month's supply. Those additional vials are being shipped Tuesday to hundreds of U.S. hospitals and treatment centers, the FDA said.

The FDA also noted that it continues to work with other manufacturers of methotrexate that have also stepped up production. Those manufacturers include Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N.J.

At a midday news conference Tuesday, one of the speakers was Sara Stuckey, mother of 6-year-old Nate Stuckey, who has been on methotrexate since he was diagnosed with ALL in 2009.

"It is hard enough to hear your child has cancer, but to hear that the treatment that is successfully working is suddenly not available is devastating," she said. "My husband and I pray the recommended drugs to fight his cancer will be available when it's time for Nate's next treatment. And we hope that in the future no more families have to go through the stress of wondering whether proven, lifesaving treatments will be out of reach when they need it the most."

Speaking at the news conference, Hamburg said: "There are too many families like the Stuckeys who worry they won't have the medication they need for their next treatment and are understandably anxious about switching to a medication that may have more side effects or may be less effective. Clearly this is not acceptable."

"We are making progress," Hamburg added. "There were 195 drug shortages prevented in 2011 and 114 drug shortages prevented since October 2011 when we made the call for early notification" of potential shortages.

As for the ovarian cancer drug Lipodox, the FDA said it will allow the temporary importation of the drug made by Sun Pharma Global FZE. The agency said in its news release that "temporary importation of unapproved foreign drugs is considered only in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs."

The shortages of methotrexate and Doxil are just the latest in a series of drug shortages that have existed for several years.

In 2011, prescription drug shortages in the United States hit an all-time high. Last fall, some 200 drug shortages had been reported, compared to 178 in all of 2010, the FDA reported.

Many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are only given in hospitals and are "absolutely critical," Valerie Jensen, associate director of the FDA's drug shortage program, said during a news conference last September.

More than half (54 percent) of shortages in 2010 were due to quality issues, such as drug impurities. Some were caused by delays or manufacturing capacity problems, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen said.

Jensen also said the shortages tend to occur in drugs that aren't "economically attractive." This could mean that only one company produces the drug, making it harder to find alternatives if the supply dries up.

A lot of the problems are tied to generic drugs, health experts explained, because few manufacturers make them and profit margins aren't as high as for brand-name drugs still under patent protection.

On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The order directed the FDA to "take action" to prevent and reduce worsening prescription drug shortages.

In response to Tuesday's announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), said in a statement: "ASH is encouraged by the steps FDA is taking to alleviate drug shortages that have significantly affected so many patients with hematololgic malignancies under our members' care. The measures announced today are consistent with the Society's recommendations to FDA, Congress and the Obama Administration to expand the agency's authority to prevent drug shortages by requiring manufacturers to provide early notification of impending shortages and importing drugs in critical supply."

"While ASH applauds the specific actions announced today," Keating added, "we also realize that these measures represent only a portion of a solution to a much larger problem. In addition to these steps, additional measures -- such as developing a national drug registry and providing economic incentives to manufacturers to produce a steady supply of generics -- must be implemented to permanently prevent shortages. Until a complete solution is in place, treatment will be delayed and care will be rationed for critically ill patients."

More information

For more on drug shortages, visit the U.S. Food and Drug Administration.

SOURCES: Feb. 21, 2012, news conference with Margaret Hamburg, M.D., commissioner, U.S. Food and Drug Administration, and Sara Stuckey, mother of 6-year old cancer patient, Nate Stuckey; Feb. 21, 2012, news release, U.S. Food and Drug Administration; Feb. 21, 2012, news release, American Society of Hematology

Copyright © 2012 HealthDay. All rights reserved.

View the original article here

Peliculas Online