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FDA Approves Caldolor – Injectable Form of Ibuprofen

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The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn.

Source: FDA, June 11, 2009

Samsca Approved by FDA to Treat Hyponatremia

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The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood.

“With the approval of Samsca, physicians will have an additional tool to treat hyponatremia,” said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

Samsca is approved to treat hyponatremia associated with congestive heart failure, liver cirrhosis, and the syndrome of inappropriate antidiuretic hormone secretion.

When sodium levels drop in the fluid outside of cells throughout the body, water moves into cells to balance the sodium levels and causes the cells to swell. Swelling of the brain cells is thought to cause many of the symptoms of hyponatremia. Those symptoms may include fatigue, weakness, headache, nausea, confusion or decreased consciousness, and convulsions. Severe hyponatremia, which has not been studied with Samsca, can lead to coma and death.

Samsca helps raise sodium levels in the blood by removing extra body water in the urine. Patients using the drug in clinical trials had a greater degree of increase in sodium levels in the blood compared with patients taking a pill containing no active drug (placebo).

Samsca is being approved with a boxed warning to alert health care professionals and patients that the drug should be started only in a hospital where blood sodium can be monitored closely. Too rapid a rise in sodium can cause a serious condition called osmotic demyelination syndrome (ODS). ODS can lead to coma or death and can also cause symptoms such as trouble speaking, trouble swallowing, drowsiness, confusion, mood changes, seizures and trouble controlling body movement with muscle weakness in the arms and legs.

Although no cases of ODS were seen in clinical trials of Samsca, ODS is a known risk and it is essential that physicians be aware of it and avoid rapid rises in sodium. Additionally, the FDA is requiring a Risk Evaluation and Mitigation Strategy that requires a patient Medication Guide be given out when the drug is dispensed. The Medication Guide will provide information about the drug’s benefits and risks.

The most common adverse reactions with use of Samsca reported by patients in clinical trials include thirst, dry mouth, weakness, constipation, making large amounts of urine, urinating often, and increased blood sugar levels.

Samsca is marketed by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.

Source: FDA, May 22, 2009

FDA Approves Use of Temporary Pump to Assist Heart’s Right Side

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The U.S. Food and Drug Administration(FDA) today approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of the heart. The approval is a first for certain critically ill patients.

Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart’s left ventricle, which pumps oxygen-rich blood to the rest of the body. The pump, manufactured by Levitronix LLC, is called the CentriMag Right Ventricular Assist System, is intended for patients requiring support for the heart’s right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.

HDEs facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the United States every year. To receive approval of an HDE application, a company must demonstrate the product’s safety and probable benefit. Such products are generally used under the supervision of an Institutional Review Board, a committee that approves, monitors, and reviews biomedical research within a locality.

“This device will provide patients with much needed time until a more permanent treatment option is available,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “The approval reaffirms the FDA’s commitment to even the smallest patient populations.”

The CentriMag system is for critically ill patients with a failing right ventricle when other therapies have failed. It is intended to be used for up to 14 days to keep the patients alive until their heart recovers or until a heart transplant or long-term heart assist device can be implanted.

While severe right-side heart failure is uncommon, it can lead to death. It is often caused by left-side heart failure or, in unusual cases, by heart surgery.

Safety data from two multi-center clinical trials showed that the CentriMag system does not expose patients to an unreasonable risk, and the probable health benefit from use of the device outweighs the risk, taking into account the probable risks and benefits of alternative forms of treatment.

Because shortness of breath is common in patients with right-sided heart failure, it is unclear whether the device caused any of the breathing difficulties reported in the study group.

Patients who are unable or unwilling to take anti-clotting medicine should not use the CentriMag system, because bleeding and blood clots are two of the most common adverse events associated with heart assist devices.

The CentriMag Right Ventricular Assist System is manufactured by Levitronix LLC, Waltham, Mass.

Source: FDA

Experimental Malaria Vaccines to be Tested in FDA and PATH-MVI Collaboration

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The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials.

“This collaboration with the PATH-MVI supports the overall mission of the FDA and specifically the Agency’s work under our Critical Path Initiative,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “We are actively seeking ways to help organizations such as PATH develop safe and effective products that can benefit the public health both in the United States and globally.”

PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions to improve global health and well-being. PATH-MVI supports the development of malaria vaccines and is expected to spearhead the efforts to ensure their availability and accessibility in the developing world once a safe and effective vaccine becomes available.

The PATH-MVI collaborative project is expected to span about three years and is being conducted under the Cooperative Research and Development Agreement (CRADA) program, which allows federal laboratories and businesses to form partnerships that help expedite research activities. Recent scientific advances suggest that vaccines based on live, weakened (attenuated) malaria parasites may be possible in the future but assessing safety and effectiveness in the early stages of product development is challenging. Under this CRADA, PATH-MVI provides the FDA with about $1.5 million to develop tests for evaluating malaria vaccines early in their development.

To date, there are no approved vaccines to prevent malaria but several vaccines are in development. This CRADA will help develop laboratory tests to assess whether a vaccine candidate is safe enough to begin Phase I clinical trials.

Each year 350-500 million cases of malaria occur worldwide, killing an estimated one million people, most of them young children in sub-Saharan Africa. Travel between the United States and the affected areas, as well as men and women in the U.S. military who are stationed in regions at high risk for malaria, can bring the disease into the United States.

The Center’s Global Vaccine Initiative fosters the development, evaluation and availability of vaccines needed to protect against major global infectious diseases and is part of the Center’s commitment to work with others, including the World Health Organization, in advancing global public health.

The Critical Path Initiative is the FDA’s effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated and manufactured.

FDA Calls for Warning on Cipro, Levaquin and Other Antibiotics

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The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. “The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be “new safety information” as defined in FDAAA.

The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA 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. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients’ and prescribers’ understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.

Health care professionals should consider the potential benefits and risks for each patient. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.

Source: FDA, July 8, 2008

FDA Warns of Cancer Risk for Regranex in Treatment of Diabetics’ Foot and Leg Ulcers

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The U.S. Food and Drug Administration (FDA) has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

In late March, 2008 the FDA issued an Ongoing Safety Review Communication on Regranex notifying the public that it was conducting a safety review. This follow-up communication is in keeping with FDA’s commitment to notify the public of any regulatory changes with this FDA approved product.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

Source: FDA, June 6, 2008

FDA Approves NovoSeven RT Coagulation Therapy

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A new formulation of a genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood—has been approved by the FDA. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years.

"Approval of this product for room temperature storage creates greater flexibility in disease management for both patients and physicians," said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. "As with all FDA-approved products, the agency will monitor NovoSeven RT throughout its life cycle."

NovoSeven RT—the new formulation of NovoSeven Coagulation Factor VIIa (Recombinant)—contains sucrose and L-Methionine, which allow for storage at room temperature. This is helpful for health-care facilities with limited refrigerated space. The original formula could be stored for three years at temperatures between 36 and 46 degrees Fahrenheit.

NovoSeven RT shares the same uses as the earlier NovoSeven product. These uses include the treatment of bleeding and the prevention of surgical bleeding in patients with hemophilia A or B, who have antibodies that neutralize the action of clotting Factors VIII or IX; the treatment of bleeding and the prevention of surgical bleeding in patients with congenital Factor VII deficiency; and the prevention of surgical bleeding in patients with acquired hemophilia.

Coagulation factors are proteins found in plasma, which help blood clot. When one or more of these proteins are missing or inactive, bleeding can occur.

The most commonly observed adverse reactions with NovoSeven RT are fever, bleeding, injection site reaction, joint discomfort, headache, elevations or falls in blood pressure, nausea, vomiting, pain, swelling, and rash. Some elderly patients experienced an increased risk of arterial clotting when they were treated with NovoSeven RT outside of its approved indications.

NovoSeven RT and NovoSeven Coagulation Factor VIIa (Recombinant) are manufactured by Novo Nordisk A/S, located in Denmark.

Source: FDA, May 9, 2008

New Crohn’s Disease Treatment Approved by FDA

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The U.S. Food and Drug Administration (FDA) has approved a new medicine called Cimzia for the treatment of Chron’s disease. The drug is manufactured by UCB, Inc., and is known as a tumor necrosis factor (TNF) blocker. It is used to reduce the signs and symptoms of moderately to severely active Crohn’s disease in adult patients who have not been helped enough by usual treatments.

Crohn’s disease is a condition that causes inflammation of the gastrointestinal tract, and most commonly occurs at the lower end of the small intestine. Typical symptoms include diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. The disease affects more than 1 million men and women worldwide. It has no cure and its cause is unknown.

"Crohn’s is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA’s Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn’s, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.

Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body’s ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data.

Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.

FDA Approves Amitiza to Treat Irritable Bowel Syndrome (IBS-C)

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The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.

Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress to its sufferers. It affects at least twice as many women as men.

"For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Julie Beitz, M.D., director of the Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA. "This drug represents an important step in helping to provide medical relief from their symptoms."

The safety and efficacy of Amitiza was established in two major studies involving 1,154 patients diagnosed with IBS-C. The majority of the patients studied were women (approximately 8 percent were men). Patients enrolled in the studies were experiencing at least mild abdominal discomfort or pain that was associated with at least two of the following additional symptoms: 1) fewer than 3 spontaneous bowel movements per week (that did not result from laxative use); 2) hard stools; or 3) moderate or severe straining with bowel movements. In the studies some patients received Amitiza and others were given a placebo. More patients treated with Amitiza reported that their IBS symptoms were moderately or significantly relieved over a 12 week treatment period than patients who received placebo. The safety of long term treatment was assessed in a study in which all patients were treated with Amitiza for a duration that ranged 9 to 13 months.

The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C.
Amitiza, like most prescription medications, is accompanied by some side effects. Common side effects of Amitiza include nausea, diarrhea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope (fainting), peripheral edema (swelling of the extremities), dyspnea (difficulty breathing), and heart palpitations.

Amitiza should be taken twice-a-day in 8 microgram doses with food and water. Patients and their health care professionals should periodically assess the need for continued therapy.

Amitiza is not approved for use in children and men. It is not to be administered to patients suffering from severe diarrhea or patients with known or suspected bowel obstructions. Its safety and efficacy has not been established in patients with renal or hepatic impairment, pregnant, or nursing mothers.

Amitiza is also approved for the treatment of chronic idiopathic constipation (CIC), but the dose for that indication is higher, 24 micrograms twice a day.

Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, MD, and will be jointly marketed by Sucampo and Takeda Pharmaceuticals America, Inc., Deerfield, IL. As with all FDA-approved products, the agency will monitor Amitiza throughout its life cycle. Consumers and health care professionals are encouraged to report adverse events to the FDA.

Source: FDA, April 29, 2008

Is the Information We Have About Pharmaceutical Drugs Really Reliable?

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A report in the current issue of the British Medical Journal questions the reliability of what we know about the latest drugs, such as antidepressants or statins.

The Food and Drug Administration Amendments Act (FDAAA) of 2007 stipulated that the results of clinical trials conducted for a new drug are published in a public database, say journalists Jeanne Lenzer and Shannon Brownlee. Despite this Act, lack of access to reliable data remains an ongoing problem. Not all trials have to be registered, while trade secrecy laws protect other products from providing access to full data.

Data can be demanded under the Freedom of Information Act, but trade secrecy laws allow information about a drug that is not approved for a new indication to be withheld, even though the drug is already being marketed for other indications. The stated purpose of these trade secrets is to prevent a company being placed at a "competitive disadvantage" to other companies.

For example, in 2001 Valdecoxib, a COX 2 inhibitor failed to obtain FDA approval as a treatment for acute pain. Some of the trial information was removed from the FDA website, with the public and medical researchers unaware of possible side effects—a situation that should be remedied at once, say the authors.

One possible solution would be to make the FDA database available to researchers, a move resisted by the FDA which claims that putting all its data online would be too burdensome. But doing this future Freedom of Information requests would be reduced, say the critics. Failing to make trial participant data available to the public has to be accomplished, if the public interest is to be served, say the authors.

Source: British Medical Journal, Volume 336, pp 532-534