Posted tagged ‘food and drug administration fda’

Plague Medication Approved by the FDA

June 7, 2012

(June 7, 2012) At the end of May, the U.S. Food and Drug Administration (FDA) approved a drug to treat patients with plague, a rare and potentially life-threatening bacterial infection.


In addition, Levaquin (levofloxacin) was also approved to reduce the risk of getting plague after exposure to a bacterium, which causes the disease, known as Yersinia pestis.


Although plague is extremely rare in most parts of the world (only 1,000 to 2,000 cases per year), and is primarily an animal disease, plague may be spread to humans from an infected flea, contact with infected animals, or laboratory exposure.


The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood).


The Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, Edward Cox, M.D., M.P.H., said that this “approval broadens the available therapeutic treatments for plague. It also further demonstrates the usefulness of animal model studies to collect needed efficacy data in cases where human trials are not ethical or feasible.”


The agency approved Levaquin under the Animal Efficacy Rule, which allows research on animals in cases where it is not feasible or ethical to conduct trials in humans, so long as the studies are adequate and well-controlled.


The study was conducted on African green monkeys infected with the plague bacterium in a lab setting. Animals were randomly selected to receive a 10-day regimen of Levaquin or placebo within six hours of the onset of fever after being infected. 94 percent of the 17 monkeys (roughly 16) treated with Levaquin survived, but none of the seven monkeys treated with the placebo survived.


Common side effects of Levaquin, reported in more than three percent of patients, were nausea, headache, diarrhea, insomnia, constipation, and dizziness. In addition, such rare but serious side effects include tendinitis and tendon rupture, worsening of muscle weakness in people with the neuromuscular disorder myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm.


As always, when dealing with these FDA-approved drugs, is to determine if taking this medicine is worth it in your situation, and decide if the risks in not taking the medication outweigh the benefits that the medication provides. Since plague is a very serious, potentially deadly condition, it would almost always seem that taking Levaquin outweighs any risk of its side effects.


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Lawsuits Filed Against Manufacturer of Dangerous Pradaxa

May 24, 2012

(May 24, 2012) – Pradaxa, a blood thinning drug which the U.S. Food and Drug Administration (FDA) is investigating for causing serious, possible fatal bleeding in patients. Doctors prescribe Pradaxa to help reduce strokes and prevent blood clots in patients diagnosed with atrial fibrillation (AFib), sometimes referred to as an irregular heart beat. This drug has been linked to bleeding so severe that it can cause heart attacks and possibly result in death. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceutical GmbH & Co. KG of Germany.


The FDA issued a safety alert regarding Pradaxa in December 2011. The FDA is conducting a safety review of reports of serious bleeding related to taking Pradaxa. Health agencies in Europe, Japan and New Zealand have also reported cases of severe and sometimes fatal bleeding, which may have been caused by Pradaxa. The drug was introduced as an alternative to warfarin, a commonly used anti-coagulant.  However, unlike warfarin, severe bleeding caused by Pradaxa cannot be stopped by injections of vitamin K.  In addition, there are no good antidotes for bleeding caused by Pradaxa. More than two million Americans have atrial fibrillation, which makes them prone to blood clots, which can cause strokes. Lawsuit claims against drug makers allege that the company failed to completely research its side effects and promoted it as a safe alternative to warfarin. Warfarin (Coumadin) is an established medication that has a reversal agent if bleeding problems occur. These lawsuits also allege that the manufacturer failed to adequately warn about Pradaxa’s lack of any reversal agent. In any case, Boehringer Ingelheim promoted its blood thinners as a more convenient alternative to warfarin because it requires less monitoring.


Pradaxa is relatively new to the market, being approved by the FDA in October 2010. Pradaxa is used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. From its approval until August 2011, approximately 1.1 million Pradaxa prescriptions were dispensed to 371,000 patients.  There have been 250 deaths associated with Pradaxa as reported in the Bloomberg News.


Pradaxa has serious side effects to be concerned about. Serious bleeding incidents may occur in patients, even after minor injuries like a fall or bump to the head, which is a well-known complication of all anti-coagulant therapies.  In addition, a study done in January 2012 showed that Pradaxa patients had a 33 percent greater chance of heart attack or severe heart disease symptoms than those taking warfarin. Patients taking Pradaxa are also warned that bruising may occur more easily and take longer for the bleeding to stop. Patients are instructed to seek immediate care from a doctor if any signs or symptoms of bleeding are noticed:


–       unexplained bleeding from the gums

–       frequent nose bleeds

–       heavier than normal menstrual or vaginal bleeding

–       severe or uncontrollable bleeding

–       unexplained bruises that grow in size

–       coughing up blood or blood clots

–       vomiting blood or vomit that looks like coffee grounds

–       urine that is pink or brown

–       stools that are red or black and look like tar


The FDA is working with the manufacturer to analyze post market reports to identify possible evidence of inappropriate dosing, drug interactions or other clinical factors that might lead to uncontrollable bleeding.


Before patients discontinue use of Pradaxa they should discuss with their doctors. Stopping the use of blood thinning medications can increase the risk of stroke, leading to permanent disability or death.


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Bone Drugs Linked to Thigh Fractures

May 23, 2012

(May 22, 2012) – Bone strengthening drugs (bisphosphonates), more commonly known as alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel), and zoledronic acid (Reclast), were first introduced in the mid 1990s, and have become a popular treatment for osteoporosis.  Many women who suffer from osteoporosis following menopause take these bone strengthening drugs to reduce the risk of fractures.


A review conducted by the U.S. Food and Drug Administration (FDA) recently published in The New England Journal of Medicine questions whether or not there is any benefit to staying on these drugs long-term, in light of their potential for side effects.  A report in the Archives of Internal Medicine yesterday found that osteoporosis drugs significantly raise the risk of a rare, but serious, thigh fracture. Researchers noted that the longer the patient took the bisphosphonates, the greater the risk.  Although the researchers noted that studies generally support the benefits of osteoporosis medications to strengthen bones and prevent fractures, they suggested that patients re-evaluate whether or not to continue taking the drugs longer than 3-5 years.


Bisphosphonates have raised safety concerns in the past, including heart risks. In 2008, the FDA said it found no link between the drug and heart problems. In 2010, the FDA ordered drug labels to include a warning about the possibility of thigh fractures. In 2011, an expert panel sanctioned by the FDA, expressed concern over the possibility of atypical fractures.


In a current study, Swiss researchers examined records of 477 patients treated for broken legs; 438 of them had typical fractures caused by falls and other accidents. However, 39 of them had broken femur bones, caused by minimal or no trauma; 32 of the 39 with atypical thigh breaks had taken bisphosphonates – 82 percent; and 7 of the 32 had atypical fractures in both thighbones.


Some experts believe bone-strengthening drugs are being over-prescribed for healthy people.  It has been shown that bisphosphonates can actually weaken bones by impairing their ability to heal, leading to fractures, in a study conducted by researchers from N.Y. Presbyterian Hospital/Weill Cornell Medical Center.


Here’s how bisphosphonates work:  Bones undergo a constant process of breakdown (called resorption) and rebuilding. When bones break down faster than they can rebuild, they become weak – the condition known as osteoporosis. Weakened bones make people more vulnerable to fractures if they fall. Bisphosphonates decrease bone resorption, which helps maintain bone density and keep the skeleton strong.


In addition to the increased risk of thigh fractures, a study conducted by researchers from the University of Washington and published in the Archives of Internal Medicine showed Fosamax appears to double women’s risk of developing a chronic irregular heartbeat known as atrial fibrillation. This can lead to dizziness, fatigue and momentary loss of consciousness.


There were studies reported in The New England Journal of Medicine in 2006, warning about the link between bisphosphonates and osteonecrosis of the jaw (ONJ), also referred to as “dead jaw”, where the jaw bone dies.  Doctors had thought this was triggered by having teeth pulled, and there were warnings to avoid pulling teeth whenever possible. It was thought to be a growing epidemic and was directly linked to these drugs for osteoporosis.


Most drugs have side effects.  But, you would not expect a drug marketed for strengthening of the bones to actually cause the bones to break.  It is bad enough that these osteoporosis drugs had a risk of “dead jaw”.  When the reports surfaced regarding atrial fibrillation, women had to weigh the risks and benefits of taking these drugs. But now, the newest studies found that these bone drugs are actually increasing the risk of bones fractures! It seems that with all the new side effects linked to these bone drugs, maybe sticking with plain old exercise may be the best way to go, as exercise is one of the most effective ways to keep bones strong.


What do you think about these findings? Would you still risk taking these bisphosphonates? Comment on this blogpost; we look forward to hearing your feedback.


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Accutane May Lead to IBD, Crohn’s or Ulcerative Colitis

February 27, 2012

(February 26, 2012) Accutane lawsuits are being filed across the country against its drugmaker, Hoffman-LaRoche, currently known as Roche Laboratories.  There is a direct link between Accutane and Inflammatory Bowel Disease (IBD), Ulcerative Colitis, or Crohn’s Disease.


Accutane was approved in 1982 by the U.S. Food and Drug Administration (FDA) to treat severe acne, and is classified as a retinoid. The main ingredient in Accutane is isotretionoin, derived from vitamin A. It works by drying up sebum (oil) produced by the skin glands. When too much sebum is produced, it leads to bacteria, inflaming the skin follicles, leading to acne. Generics are also available for Accutane, known as Amnesteem (from Genpharm and Mylam), Claravis (from Teva-Barr), and Sotret (from Ranbaxy).


But as productive as Accutane is, both as a moneymaker and a therapy, it also has the potential to destroy lives. Because of its exceptional power to cure acne, Accutane had been praised as a “miracle drug” by the FDA when it was first introduced.


However, Accutane has been associated with several, serious side effects for many years. There is currently a Black Box warning cautioning consumers about the potential to unborn children, which is the highest warning label the FDA can designate. There are additional, serious side effects, including depression, IBD, liver disease, Crohn’s disease, and ulcerative colitis.


Inflammatory bowel disease, Crohn’s disease, and ulcerative colitis affect more than a million Americans, for which there is no cure.  Symptoms vary for each of these specific diseases, but abdominal pain and cramping are common in all of them. Many patients experience diarrhea, sometimes with blood, fatigue, poor appetite, fever, irritation of the intestines, pain in the joints, skin conditions, and in severe cases, surgery is necessary to remove the affected area. Treatment for these conditions require dietary changes, anti-inflammatory medications, antibiotics if bacteria is present, and at times, immunosuppressants may be necessary. In the worst of cases, surgery would be the only solution.


In a retrial, a New Jersey jury has awarded $25.16 million (nearly 10 times the original award) to an Alabama man with inflammatory bowel disease.  The jury ruled that Roche Laboratories failed to warn Andrew McCarrell’s doctor about the risk of IBD from its Accutane drug. He was a 24 year-old college athlete when he began Accutane to treat his acne. Shortly after discontinuing the drug, he developed chronic ulcerative colitis and within a year had to have his colon removed. He was originally awarded $2.62 million in damaged by a jury, but the verdict was reversed on appeal and remanded for a new trial. Although McCarrell was “very happy” with the verdict, his lawyer added that in view of all he has been through, “nobody in their right mind would change places with Andy.”


So far, six plaintiffs have won a total of $56 million in damages over allegations that Roche knew, or should have known, about the risks of IBD from Accutane. Many other verdicts are being appealed, and there are currently over 7,000 Accutane lawsuits pending in N.J. state court.


Nobody in their right mind would opt for the risk of developing IBD, Crohn’s, or Colitis, just to get rid of a few pimples. That being the case, it should be left up to the consumers to decide whether they want to take this risk. But, because Roche Laboratories decided not to warn of these risks, many people are left debilitated, stuck with an inflammatory disease of which there is currently no cure. Is this justice?


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Johnson & Johnson Sold Hip Implants Overseas After Their U.S. Rejection

February 21, 2012

(February 21, 2012)  The second largest healthcare giant in the world, Johnson & Johnson, continues to sell hip implants in European countries and elsewhere overseas after the U.S. Food and Drug Administration (FDA) rejected its sale in the United States, based on the review of company safety studies, as reported by The New York Times.


During that period, the company continued to sell a related model in this country, which earlier went on the market using a regulatory loophole, which did not require similar safety review.


An orthopedic hip replacement joint, called an articular surface replacement (ASR) Hip Resurfacing System was being sold in Europe and elsewhere overseas since 2003 by DePuy (a Johnson & Johnson company)


The FDA rejected a version of DePuy’s ASR hip replacement procedure called “resurfacing,” which is a bone-sparing alternative to standard surgery. Because resurfacing was a new procedure when the implant was first sold in 2003, the FDA required DePuy to conduct clinical trials before they could sell the device in the U.S.


In 2005, DePuy found a way to win FDA clearance to sell a version of the ASR, based on the same metal cup for use in joint replacement surgery. Since that version was similar to hip implants already on the market, the FDA was authorized to clear it for sale without testing.


During the eight years on the market, the two implants were used in approximately 93,000 patients worldwide, one third of them in the U.S.  Both models were made of an all-metal hip socket cup, which experts say was faulty in design. Reports were received that the devices were failing at an unusually high rate.


There is no suggestion that Johnson & Johnson did anything illegal. Regulatory standards in European countries for approving the sale of medical devices are lower than in the U.S. A spokeswoman for the British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify them when the FDA refused to approve a product that was used in patients there.


In August 2009, the FDA sent a confidential letter to DePuy, listing problems with the clinical data and the devices concerning the ASR Hip Resurfacing System (which was already being sold overseas for about six years).


Within weeks of receiving the FDA letter, DePuy executives began to slowly phase out ASR sales, while directing surgeons to other company implants. Three months later, the company publicly announced its decision to phase out the ASR, stating the reason was declining sales, and that they had withdrawn their FDA application for the resurfacing version of the device.


In March 2010, The New York Times disclosed that FDA records showed that the agency had received 300 complaints regarding the ASR, almost all of them involving patients who had to undergo a second hip replacement, called a revision surgery, just a few years after receiving the device. The number of patient complaints has since reached about five thousand.


In August 2010, after data in a British registry of orthopedic patients showed high failure rates for the ASR, DePuy recalled both versions of the device.


The company advised patients with an ASR device, which was marketed to younger, more active patients to last about 15 years or more, to visit their surgeons to evaluate the implant’s performance. It also recommended annual monitoring to “ensure the ASR hip replacement is functioning well, even in the absence of symptoms.” Even without “symptoms”, many ASR patients were found to have elevated cobalt and chromium, which are metals found in the ASR systems.


Despite the fact that DePuy/Johnson & Johnson were aware that some patients were crippled by tiny particles of metallic debris, and thousands more required revision surgery, they still went ahead and sold their “rejected” implants overseas. However, the larger issue is the fact that the company did not disclose the contents of the FDA letter. This letter possibly could have had an impact on the health and safety of the company’s clients, the patients of the hospitals and doctors, as well as the financial status of the company.  Why would DePuy keep the contents of the FDA’s letter under wraps?


Thousands of lawsuits by patients suffering with the ASR implants await an outcome to this unfortunate situation.  It is said that last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall.  It is a disgrace to think that such a huge, well known healthcare giant like Johnson & Johnson can hide facts from us and knowingly risk the health and safety of human lives in other countries just to make a buck. Is this justice?



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FDA Testing Orange Juice: Positive for Fungicide

February 7, 2012

(February 7, 2012) About a week ago, the U.S. Food and Drug Administration (FDA) said it had detained eleven shipments of orange juice imports at the border, after they tested positive for the fungicide carbendazim at the levels of at least 10 parts per billion.  The FDA’s testing of all imported orange juice for carbendazim, which is applied to prevent mold on orange trees, is expected to continue through July 2012.


Since the FDA announced last month that it was sampling imported orange juice from Brazil and other South American countries for a fungicide that is not approved for use on oranges in the United States, the price of Florida oranges has skyrocketed.  For the American consumer, this may hurt their pocketbooks as early as March., a Maryland-based consulting firm, agrees this testing will have a ripple effect, leading to increased prices at the supermarket. It also points out that while orange juice with 10 parts per billion of the chemical is not allowed in the U.S., grape juice is allowed to contain 5 parts per million (not billion), and apple juice 2 parts per million.


Major companies, such as Pepsi-Co-owned Tropicana and CocaCola-owned Minute Maid have been buying up more Florida oranges lately. Normally, these two giant companies sell a blend of juice from Florida and Brazil.  Tropicana said in January that it would start purchasing only Florida oranges in its Pure Premium orange juice because of an unrelated decision it made “some months ago.”  Minute Maid officials said they would use “Florida oranges in higher amounts, but not exclusively.”


Indian River Select, Orchid Island, and other niche products, such as Uncle Matt’s Organic, also do not use flavor packs. The flavor packs contain natural oils from oranges, stripped off, then added back. Big companies use them so they can be stored for months. That is why every carton of Tropicana Pure and Minute Maid’s Simply Orange has a uniform flavor. This is common practice in big national brands and in private-label brands. The smaller producers of Florida orange juice, Orchid Island and Indian River Select, are bragging what their juice is and is not. They claim that it is not imported on ships, and not stored in million-gallon vats for a year’s time, such as the larger companies’ juice are.


Once again, the big companies don’t care if they poison us, as long as their profits are there.  I would rather pay a few cents extra to support the smaller companies who actually produce quality products and have to compete with the giants. It is recommended that you should check the container before purchasing orange juice, to make sure it does not say anything about Brazil, and is made entirely in the United States.


What are your thoughts? Are you concerned? Do you think you will start looking at the containers and avoiding orange juice made with oranges from Brazil or other South American countries? Leave your comments on our Facebook and Twitter pages. You may also stop by our website, or contact one of our attorneys at 1-800-246-HURT (4878) for more information.

Drug Slows Prostate Cancer Spreading to Bone

February 6, 2012

(February 6, 2012) Earlier today, the U.S. Food and Drug Administration (FDA) reported of an exciting development that has been made regarding the slowing down of prostate cancer spreading to the bone.


The drug is called Xgeva, and is said to slow the spread of cancer to the bone in males suffering from difficult-to-treat prostate cancer. However, it does not extend life, and cause significant side effects. The review was made public before Wednesday’s meeting of an FDA panel of outside experts, who will discuss whether or not to consider recommending approval of the injectable drug as a preventive measure for patients with recurring prostate cancer, posing a high risk of bone metastasis (spreading to the bone), as reported by the Associated Press.  Five percent of patients taking the drug did develop osteonecrosis of the jaw (ONJ), meaning that the bone dies as a result of poor blood supply.


Xgeva, manufactured by Amgen, already has approval in the prevention of fractures in cancerous bones. Prolia, a different formulation of Xgeva, is approved for osteoporosis.


The FDA panel reviewed an Amgen-conducted study of 1,432 patients and have found that Xgeva slowed the spread of cancer to the bone by approximately 4.2 months, as compared to the placebo, as reported by the Associated Press.


This is great news to prostate cancer patients. However, it may be a good idea to wait and see how serious the side effects are, and if the trade-off is worth taking this drug to avoid terrible spread of cancer to the bones.  Hopefully, they will perfect this drug and remove all side effects in time.


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