Yourlawyer.com (Humira News)

FDA Releases More Humira, Enbrel, Remicade Info

Tue, 01 Sep 2009 00:00:00 -0700

Federal regulators have released more information regarding cancers associated with drugs like Humira, Enbrel, and Remicade. Last month, the Food & Drug Administration (FDA) had mandated that the Black Box Warnings on these drugs - known as TNF blockers - highlight their possible association with lymphoma and other cancers in children and teens.

In a supplementary "Question and Answer" document released yesterday, the FDA provided more information on the types of cancers seen in children and teens treated with TNF blockers. According to the document, the following types of pediatric malignancies were reported between 2001 and 2008:

Hepatosplenic T-cell lymphoma, 10 cases
Non-Hodgkin’s lymphoma, 7 cases
Hodgkin's lymphoma, 6 cases
Leukemia, 6 cases
Malignant Melanoma, 3 cases
Thyroid cancer, 3 cases
Basal cell carcinoma, 1 case
Lymphoma and AML, 1 case
Leiomyosarcoma, 1 case
Nephroblastoma, 1 case
Renal cell carcinoma, 1 case
Metastatic hepatocellular cancer, 1 case
Malignant mastocytosis, 1 case
Neuroblastoma, 1 case
Colorectal cancer, 1 case
Yolk sac tumor, 1 case
Myelodysplasia, 1 case
Bladder cancer, 1 case

These 48 cases of pediatric cancers included both U.S. (32) and non-U.S. (16) cases. According to the document, 31 cases of malignancy were reported in children taking Remicade, including 10 cases of hepatosplenic T-cell lymphoma in patients with inflammatory bowel disorder; 15 cases of malignancy in children receiving Enbrel were reported; and two cases of malignancy in children receiving Humira were reported. The FDA also said that the 48 cases of pediatric cancers did not confirm a dose association with malignancy.

Last month, the FDA had said that there were 11 deaths among the 48 cases of cancer. The causes of death included hepatosplenic T-cell lymphoma (9 cases) and T-cell lymphoma (1 case). In the remaining case, the patient died from sepsis after achieving remission of the lymphoma.

In children, TNF blockers are used to treat rheumatoid arthritis, inflammatory bowel disorder and Crohn’s disease. They are also approved to treat a variety of chronic, inflammatory and autoimmune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF blockers work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.

The FDA had been studying the link between the pediatric uses of TNF blockers and cancer since 2008.

Simponi Carries Risk of Possibly Fatal Fungal Infections

Fri, 29 May 2009 00:00:00 -0700

Simponi, a new rheumatoid arthritis drug, can cause severe and potentially fatal fungal infections, according to a new warning released yesterday by the Food & Drug Administration (FDA). Because of this risk, the agency said that when making a decision to use Simponi, doctors must balance the potential benefits with the potential risks of therapy based upon a patient’s individual need.

Simponi is one of a class of drugs known as TNF-alpha blockers. Such medications work by suppressing the immune system. Other drugs in this class include Humira, Cimzia, Enbrel, and Remicade. Simponi was only approved in April as a treatment of adult patients with: moderate to severe rheumatoid arthritis in combination with methotrexate, psoriatic arthritis (either alone or in combination with methotrexate), and ankylosing spondylitis.

It has long been known that people taking TNF-alpha blockers run a risk of developing opportunistic infections, including histoplasmosis, an infection caused by the fungus Histoplasma capsulatum. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF-alpha blockers. Last fall the FDA ordered the makers of TNF-alpha blockers to strengthen the existing warnings about opportunistic fungal infections linked to the drugs.

A "Dear Healthcare Professional" letter issued by Centocor Ortho Biotech, Inc. advises doctors to carefully review Simponi's prescribing information, which includes important information about the risk of serious infections including TB and invasive fungal infections, such as histoplasmosis, in a Boxed Warning.

The letter also warns that invasive fungal infections are not consistently recognized in patients taking TNF-alpha blockers. This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death. For patients who reside or travel in regions where mycoses are endemic (eg, Ohio and Mississippi River valleys and southwestern United States), invasive fungal infection should be suspected if they develop a serious systemic illness, the letter warns.

The letter also advises that patients be encouraged to report signs of infection and be closely monitored during and after treatment with Simponi and other TNF-alpha blockers for the development of invasive fungal infection. Signs and symptoms of such disorders include fever, malaise, weight loss, sweats, cough and dyspnea, pulmonary infiltrates on X-ray or serious systemic illness. TNF-alpha blockers should be discontinued in patients who develop such symptoms, and they should undergo a complete diagnostic workup. Once the infection has cleared, use of Simponi and other TNF-alpha blockers may be restarted based on a reevaluation of risks and benefits.

Humira, Kineret, Remicade May Raise the Risk of Developing Shingles

Wed, 18 Feb 2009 00:00:00 -0800

Shingles seems to be one of the adverse reactions to rheumatoid arthritis sufferers taking Humira, Kineret, and Remicade. WebMD Health News reported that these drugs, in the TNF-alpha blocker class, nearly doubled the risk of shingles—herpes zoster—in a German study involving 5,040 patient participants.

Humira, Kineret, and Remicade each increased the risk of developing shingles by 80 percent according to Anja Strangfeld, MD from the German Rheumatism Research Center in Berlin, "We compared these different types of TNF inhibitor with conventional disease-modifying anti-rheumatic drugs and we found there is an increased risk of herpes zoster in patients treated with the monoclonal antibodies." The drugs are also used in the treatment of ankylosing spondylitis, psoriatic arthritis, and Crohn’s disease because they quiet unmanageable immune responses common with these diseases, said Web MD.

The Guardian explained that rheumatoid arthritis occurs when the body’s immune system attacks joint linings, causing stiffness, swelling, and pain. Shingles occurs when the herpes zoster virus—the virus that causes chickenpox—is activated in people who have already suffered from chickenpox. Shingles cause severely painful blisters, headache, flu-like symptoms without fever, itching, tingling, pain, dizziness, weakness, vision changes, and changes in thought processes

Unfortunately, said Richard J. Whitley, MD, professor of pediatrics, microbiology, medicine, and neurosurgery at the University of Alabama, Birmingham, the drugs can not only prompt shingles in patients taking Humira, Kineret, and Remicade, the risk increases in those patients who have already suffered from shingles, reported Web MD. "It's pretty clear that if you have had previous zoster and take these anti-TNF monoclonal antibodies, you are going to reactivate it," Whitley told WebMD.

About one in five—or 25 percent—of the participants who developed shingles also suffered complications, which was more than expected, said Robert F. Betts, MD, professor of medicine at the University of Rochester, New York, according to WebMD. The risk of shingles appeared to be highest in older patients and those also taking steroids, said HealthDay News. And while a vaccine for shingles exists, it cannot be administered when anti-TNF drugs—which are immune system suppressants—are being taken as the shingles medication contains a live virus.

HealthDay News reported that severe cases of shingles—a viral infection—have been reported in patients being treated with TNF blockers and that there is an established link between the medications and fungal and bacterial infections. As a matter-of-fact, late last year, the U.S. Food and Drug Administration (FDA), urged the makers of Humira, Cimzia, Enbrel, and Remicade to increase safety warnings regarding the risk of developing opportunistic fungal infections; all of the medications carried black-box warnings concerning other safety issues, said HealthDay News.

The study was conducted at the German Rheumatism Research Centre in Berlin, Germany and its findings appear in today’s issue of the Journal of the American Medical Association, said the Guardian.

FDA Warning Over Humira Ad

Wed, 24 Dec 2008 00:00:00 -0800

Abbott Laboratories is in more hot water over its Humira advertising. Federal regulators warned Abbott about its advertisements for the company's psoriasis drug, saying the ad is misleading and makes claims not supported by scientific evidence. According to Dow Jones, the Humira (generic: Adalimumab) ad cited claims the medication is approved for patients with moderate to severe chronic plaque psoriasis. According to a U.S. Food and Drug Administration (FDA) letter dated December 16th to Abbott, Humira is only approved for a more limited patient population, said Dow Jones. The letter, said Dow Jones, was posted to the FDA’s Website yesterday.

The FDA said the Humira ad indicates the medication’s risks in "extremely" small type that “fails to adequately convey the serious risks connected to the product.” Of note, Humira carries a black-box warning, the FDA's strongest, which discusses the risk of serious—some fatal—side effects such as tuberculosis and other infections, said Dow Jones. The FDA wants Abbott to stop the ad and respond to the agency by January 2 explaining if it intends to comply with the FDA request, said Dow Jones.

Meanwhile, two years ago, a study revealed that patients taking Humira faced a three-fold risk of developing several kinds of cancer and a two-fold risk of getting severe infections. Humira is in the same class of drugs as Enbrel and Remicade, which are anti-TNF drugs or TNF blocker drugs. TNF is a small protein called a cytokine, which has a major role in the regulation of the immune system. Anti-TNF drugs confine TNF and obstruct the reaction, which causes the abnormal joint inflammation. Humira is approved for the treatment of rheumatoid arthritis and in rheumatoid arthritis, TNF levels are very high, resulting in inflammation, swelling, pain, and joint damage.

A Mayo Clinic study published in the May 17, 2006 issue of the Journal of the American Medical Association, found an apparent link between Humira and other cancers, including skin, gastrointestinal, breast, and lung tumors. According to study author Eric Matteson, a professor at the Mayo Clinic in Rochester, Minnesota, physicians might well expect to see one additional case of cancer developing within six to 12 months of treatment for every 154 patients who take the drugs and could expect to see one serious infection, such as pneumonia, within three to 12 months for every 59 patients treated. Anti-TNF antibody drugs are one of the fastest-growing prescription classes in the nation. Humira was granted FDA approval on December 31, 2002.

Dow Jones noted that Humira is also approved to treat adult patients with moderate to severe chronic psoriasis, a skin disease characterized by red patches and flaky and scaly skin, who don't generally respond to topical medications and is also approved to treat Crohn's disease, a chronic infection of the intestines.

In September, we reported that Federal regulators ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections.

Humira, Cimzia, Enbrel and Remicade to Bear Stronger Infection Warnings

Thu, 04 Sep 2008 00:00:00 -0700

Federal regulators have ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of the Food and Drug Administration Amendments Act of 2007.

Humira, Cimzia, Enbrel and Remicade are known as tumor necrosis factor (TNF) blockers. They are used to treat rheumatoid arthritis, Crohn's disease and other conditions. The drugs work by suppressing the immune system. It has long been known that people taking TNF blockers run a risk of developing opportunistic infections, and the prescribing information for the drugs has included this information. But now the FDA says that current warnings are inadequate.

The FDA's order came after the agency reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

The agency has given the makers of Humira, Cimzia, Enbrel and Remicade 30 days to submit the required safety labeling changes, including strengthened warnings and revisions to the Medication Guides, or to provide a reason why they do not believe labeling changes are necessary. If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

The FDA is also reviewing TNF blockers over a possible link to cancer. In June, the agency said it was investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin’s and non-Hodgkin’s based.

In April, the FDA had Amgen and Wyeth include a new black box warning on the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis in some patients. The Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

Humira, Enbrel, Remicade Being Investigated for Cancer Link

Wed, 04 Jun 2008 00:00:00 -0700

Humira and other drugs used to treat autoimmune disorders are being investigated by federal regulators amid concern that they might be linked to cancer in children and young people. The drugs are known as tumor necrosis factor (TNF) blockers, and are used to treat various forms of arthritis including juvenile idiopathic arthritis and Crohn's disease.

In addition to Humira, which is made by Abbott Laboratories, four other TNF blockers are currently on the market in the US. They are Enbrel, marketed by Wyeth and Amgen; Remicade sold by Schering-Plough; and Cimizia, made by UCB of Belgium. TNF blockers impede the action of a substance made by the body’s immune system called TNF. People with an autoimmune disease, such as rheumatoid arthritis, have too much TNF in their bodies.

The FDA said its review will focus on Humira, Enbrel and Remicade. Remicade is approved for use in children with Crohn's disease. Enbrel and Humira are approved to treat children with juvenile rheumatoid arthritis, according to the FDA. The FDA is requiring the maker of Cimzia to conduct a study to assess long-term risks of the product, including lymphoma and other cancers. This study will begin in 2009 and take about 10 years to complete. All of the labels for the drugs currently address the possible risk of cancer when taking the drug.

The FDA is investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin's and non-Hodgkin's based.

The FDA has requested that makers of TNF blockers approved for use in children and young adults supply information about all reported cases of cancer among patients in these age groups taking the drugs. The FDA has also asked health-care professionals to weigh the possible risks against the benefits when prescribing TNF blockers.

In addition to the possible cancer risk, TNF blockers have been associated with an increased risk of some infections. In May, Enbrel had its label modified to include a black box warning - the FDA's strictest safety alert - about its association with serious infections, including tuberculosis. The warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

Cancer Risks Detailed for Arthritis Drugs

Wed, 17 May 2006 00:00:00 -0700

Rheumatoid arthritis patients taking Humira or Remicade face triple the risk of developing several kinds of cancer and double the risk of getting serious infections, a study led by the Mayo Clinic found.

The analysis builds on previous reports about the risks associated with Abbott Laboratories' Humira and Centocor's Remicade. But the earlier research focused mostly on one kind of cancer, lymphoma and infections such as tuberculosis and pneumonia.

The new study found an apparent link to other cancers, too, including skin, gastrointestinal, breast and lung tumors. It also quantifies the risks and says high doses appear to be the riskiest.

While the drugs' packaging information mentions some of the risks, the manufacturers said the new study does not prove that the medication is at fault, and they said the research was flawed.

Study co-author Dr. Eric Matteson, a Mayo Clinic rheumatologist, stressed the overall chances of developing cancer while using these drugs is still small. The researchers also noted that the medications' benefits include improving flexibility and range of movement, easing pain and increasing life expectancy, which arthritis can shorten.

In addition, the researchers noted that the risks for individual patients probably vary widely. Older, sicker people who have taken the drugs for several years probably face the highest risks, they said.

Still, the researchers said patients should be made aware of the dangers and told to seek medical help if they develop fevers, coughs or other symptoms of infection. They should also be sure to undergo the cancer screenings recommended for the general public, the researchers said.

Their study appears in Wednesday's Journal of the American Medical Association.

Matteson is working with Centocor in developing a new drug that works similarly, and he and co-author Dr. Tim Bongartz have been paid consultants to Abbott for unrelated work, but neither company funded the study. The Mayo Foundation sponsored the research.

Rheumatoid arthritis affects more than 2 million Americans, and involves a malfunctioning immune system that attacks joints throughout the body, causing pain, deformities and disability.

Dr. John Klippel, president of the Arthritis Foundation, said the study will probably not change doctors' minds, because scores of patients have benefited from the drugs. Remicade was approved in 1998, Humira in 2002.

More than a half-million patients have been treated with the two injectable drugs and a third similar medication, Enbrel, all of which block production of a protein linked with inflammation.

Enbrel was not included in the study because it differs at the molecular level, Matteson said. He said he is getting paid by Enbrel marketers Wyeth and Amgen to do a similar analysis on Enbrel alone.

Matteson's ties to Centocor and his work on Enbrel were among several omissions and errors included in disclosure statements that accompanied the study in JAMA.

He said the omissions were "errors of oversight on my part" and that he was not attempting to conceal anything. Matteson said he brought the issues to JAMA's attention on Friday.

But in an unusual move, journal editors posted a correction Tuesday on JAMA's Web site revealing that they have asked the Mayo Clinic College of Medicine to investigate.

The editors cited "the nature and extensiveness of this incorrect and incomplete reporting."

In a telphone interview Tuesday, Dr. Phil Fontanarosa, JAMA's executive deputy editor, said that "journals are not in a position to conduct full-scale, intense investigations when there are concerns. We ask the institutions to help us in getting to the bottom of these sorts of issues."

The researchers analyzed data from nine studies comparing Humira or Remicade with placebos and pooled the results. There were 29 cancers in 3,493 patients who received at least one dose of either drug, compared with three cancers in 1,512 patients on placebos.

Serious infections occurred in 126 patients on drugs and 26 on placebos. They included pneumonia and cellulitis.

An Abbott spokesperson said the analysis "doesn't reflect all the data" on Humira and said the studies were too short to sufficiently monitor cancer incidence.

Tom Schaible, Centocor vice president of medical affairs, said most of the analyzed studies used higher-than-recommended Remicade doses. "There's clearly a favorable benefits-risks ratio" with recommended doses, Schaible said.

Study: Rheumatoid-arthritis drugs may raise cancer, infection risk

Wed, 17 May 2006 00:00:00 -0700

Some drugs used to treat rheumatoid arthritis, a devastating disease that can deform bone and cause extreme pain, may increase the risk for serious infections and also some cancers in rare cases, according to an analysis of nine studies involving the drugs.

But doctors familiar with the research say the benefits of the drugs, Humira and Remicade, outweigh the risks for most people with rheumatoid arthritis.

The best course of action, they say, is for doctors to monitor their patients closely for symptoms of infection or cancer. Enbrel, a similar drug, was not included in the analysis, but a separate study is planned.

Rheumatoid arthritis affects more than 2 million Americans. It occurs when the body's immune system malfunctions and attacks joints anywhere in the body. It is a different disease from osteoarthritis, which affects 21 million Americans and begins with the breakdown of joint cartilage, causing pain and stiffness.

More than a half-million rheumatoid-arthritis patients have received therapy with the drugs so-called TNF-blocking antibodies -- which can halt the body's production of a protein that can cause inflammation. The drugs can improve range of movement, ease pain, and may increase life expectancy.

Dr. Eric Matteson, a Mayo Clinic rheumatologist who worked on the analysis published in today's Journal of the American Medical Association, said that as the drugs slow the progression of rheumatoid arthritis, they also can interfere with normal immune function.

Of 3,493 patients in the nine clinical trials who received at least one drug treatment, 29 developed cancers, compared with only three cancers in 1,512 patients who took a placebo. Serious infections, such as pneumonia, occurred in 126 patients on the drugs, compared with 26 infections in people who took placebos.

"Most of the patients appropriate for this therapy do not have other good options," Matteson said. "TNF-blocking antibodies are absolutely the best drug for many patients."

Humira Cancer Lymphoma Side Effect Lawyer

Wed, 17 May 2006 00:00:00 -0700

Injured by Humira?

On May 17, 2006 a new study discovered that patients taking Humira face triple the risk of developing several kinds of cancer and double the risk of getting severe infections. Humira (generic: Adalimumab) is manufactured by Abbott Laboratories and is prescribed to combat Rheumatoid arthritis. Humira was granted FDA approval on December 31, 2002.

Humira is in the same class of drugs as Enbrel and Remicade. These drugs are called anti-TNF drugs or TNF blocker drugs. TNF is a small protein called a cytokine, which has a major role in the regulation of the immune system. Anti-TNF drugs confine TNF and obstruct the reaction, which causes the abnormal joint inflammation.

In rheumatoid arthritis, TNF levels are very high, resulting in:

Inflammation
Swelling
Pain
Joint damage

Mayo Clinic Study
The findings of this new study can be found in the May 17, 2006 issue of the Journal of the American Medical Association. The Mayo Clinic study found an apparent link to other cancers, including skin, gastrointestinal, breast and lung tumors. Eric Matteson, a professor at the Mayo Clinic in Rochester, Minn., and an author of the study, stated that physicians might well expect to see one additional case of cancer develop within 6 to 12 months of treatment for every 154 patients who take the drugs. Doctors could expect to see one serious infection, such as pneumonia, within 3 to 12 months for every 59 patients treated. Less than 1% of patients in the study developed cancer. The Mayo Clinic study found an apparent link to other cancers, including skin, gastrointestinal, breast and lung tumors. Anti-TNF antibody drugs are one of the fastest-growing prescription classes in the nation.

Legal Help for Humira Users
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