Topamax is a prescription used in the treatment of epileptic children and adults. It has also been used for treating other conditions such as Lennox-Gastaut syndrome, migraine headaches, and bipolar disorder. It is also used to prevent weight gain among anti-depressant users. Researchers are also trying to find out about the drug’s usefulness in treating binge eating, alcoholism, obesity, and PTSD. Now available in generic form, Topamax was approved by the U.S. Food and Drug Administration (FDA) in 1996.
The body only absorbs about 30 percent of the topiramate present in every 25 mg to 200mg oral doses. However, scientists are not so sure as to how the drug works once it enters the body.
Earlier, controversies have eroded consumer confidence in Topamax. In 2008, the FDA issued a warning on Topamx. The government regulating body has evidence to support claims that the drug causes its users to commit suicide. Two yeas after, in May, 2010, Ortho-McNeill pleaded guilty for claiming that Topamax could treat psychiatric disorders it wasn’t approved to treat. Such claim was without any study or trials as evidence. Consequently, the FDA slapped the company a $6.14 million fine.
Despite the controversy, there has been neither a Topamax recall existent nor any Topamac lawsuits or Topamac class lawsuits.
In January 2008, the FDA started providing doctors a review of two hundred medical studies which involves 44,000 different people. It indicated that Topamax caused an increase in suicidal tendencies among its users. Eventually, the FDA placed a “black box” warning on Topamax.
Recently, the drug was found to have caused birth defects when pregnant women use the drug. In July 22, 2008, an article in Neurology magazine gave accounts of 203 pregnant women under Topamax medication. The research was conducted out of Belfast, Northern Ireland. Of 178 births the study described, sixteen had major birth defects. The number is thought to be eleven times over the average. Four of the sixteen children have cleft lips or palates. The disfiguring condition happens when cartilage above the lip fails to develop properly. Though the condition can be corrected surgically, it can still result in speech problems, ear disease, and difficulties in early socialization. Furthermore, four of the male babies were born with genital defects; two of which had hypospadias, a congenital defect featuring urethra that fails not locate at the tip of the penis. In its first approval, the FDA classified topiramate under category C. It means that the drug was not tested on humans, though animal tests resulted in birth defects.
Topamax users have good reason to be alarmed considering the circumstances above. If you are one of them, access more information at Topamax lawsuits online information center.
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04/03/2012
04/02/2012
Some Pointers to Consider on Accutane Lawsuits?
Of all the reported side effects of Accutane, gastrointestinal complications are the most sever. Several individuals who have suffered such complication brought by Accutane use have already considered filing an Accutane lawsuit with the legal expertise of an Accutane lawyer.
Should you?
Accutane is prescribed for the treatment of severe acne. It alleviates the worst kinds of acne symptoms, thanks to the efficacy of its major ingredient – a synthetic form of Vitamin A. Its manufacturer, the La Roche Group, is known as one of the biggest company in the industry. On top of other prescription brands for Accutane are Decutan, Sotret, Raccutane and Amnesteem.
Though the medication was originally indicated for severe acne, most dermatologists prescribe the drug even for milder cases of acne. However, this strong drug, when applied to non severe acne cases, rather bring more Accutane side effects than benefits. To know these side effects is of utmost importance for individuals who are filing for an Accutane lawsuit.
Accutane works by inhibiting the activation of the oil glands and cell growth. However, the drug is said to affect reproduction and cause gastrointestinal complications. But Accutane is reputed to clear up severe acne problems.
Nonetheless, the good that Accutane does is not without harsh side effects including Alopecia, weak skin, suicidal tendencies, birth defects, liver damage, bone loss and lowered blood count, on top of everything else.
Accutane is found to have links with gastrointestinal complications known as the IBD or Inflamatory Bowel Disease, Crohn’s Disease and the Ulcerative Colitis. Aside from these complications, other indicated incidences of drastic surgical treatment as a result of the Accutane treatment were reported. The surgery involves the removal of certain parts of the rectum and colon. The severity of the condition may vary as well as it takes several years before such adverse effects start showing up. Because of this situation, a seasoned Accutane lawyer for an Accutane lawsuit is imperative.
The list of Accutane side effects includes problems in the esophagus, liver, lower bowels and pancreas. Their symptoms include dark urine, bleeding from the rectum, heartburn, diarrhea and more.
A noted settlement of an Accutane lawsuit is that of a guy who have had 3 major surgeries involving the removal of most of his colon and rectum. The case won in favor of the plaintiff for $25.16 million.
If your health has been affected by this risky drug you might have a case against the manufacturer. Access more information from online Accutane lawsuits centers.
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Avastin Lawsuits: How an Expensive Cancer Drug is Suspected of Multiple Risks
Bevacizumab is a drug identified in the market under the brand name Avastin. The drug is manufactured and distributed by a wholly-owned subsidiary of Swiss pharmaceutical powerhouse Hoffman-La Roche, Genentech, Inc. The prescription drug is prescribed for the treatment of certain forms of cancer such as colorectal, lung, renal, brain, and others. Administered intravenously in either 100mg or 400mg doses, Avastin was first approved in February 2004. The manufacturer is now appealing the FDA’s resolution to remove its indication for breast cancer.
What makes the drug a cause for alarm?
Bevacizumab impedes the formation of new blood vessels (known scientifically as angiogenesis). It does so by obstructing a certain protein in creating new blood. Thus, it curbs the buildup of malignant tumors as nutrients are being denied to the malignant cells. This pharmaceutical breakthrough gave the FDA reason to approve it as medication against metastasized cancers. However, without FDA approval, Avastin is further used to treat macular degeneration resulting from excess blood in the retinas.
In 2008, despite the recommendation of its own advisory panel, the FDA gave the go signal for Avastin’s prescription for metastasized breast cancer solely on the basis of clinical data brought about by an accelerated approval process. In July, 2010, an advisory committee of medical cancer specialists voted overwhelmingly for the removal of Avastin’s breast cancer indication. The decision resulted from a study involving 3,000 women under Avastin medication for breast cancer that showed the drug as ineffective in prolonging life expectancies. Worse, the drug causes severe, life-threatening side effects ranging from hypertension, bleeding, worsening of coronary artery and peripheral artery diseases, perforation of nasal linings, the stomach’s, kidneys’, and bowels’. Heart attacks are not far from occurring, as well as strokes and reversible posterior Leukoencephalopathy Syndrome – a disease affecting the nervous system characterized by headache, confusion, vision loss, and seizures.
Following these finding, the FDA also considered removing Avastin’s indication for metastatic breast cancer on December 16, 2010. However, the directive does not amount to warning, and starting a medical product recall, neither by the FDA nor by Genentech, has yet to be initiated; and such inaction casts serious suspicion on the drug’s reputation considering its very expensive tag price – say, up to $100,000 per year. Now, Genentech has requested to have its case heard on January 18, 2011. There are now a score of pending Avastin lawsuits against Genentech, although a class lawsuit has yet to be known.
Know more about warnings on bevacizumab at some Avastin lawsuits online information center.
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Fosamax Lawsuits Gain From Very Important Verdict as Florida Woman Gets $8 Million
Four years ago, a Florida woman sued Merck & Co. and was recently awarded $8 million. Her Fosamax lawsuits claim that the osteoporosis drug Fosamax was the cause of her damaged jaw. The trail verdict is representative of a major landmark in litigation that totals about 900 lawsuits with pending cases against Merck. These cases of Fosamax lawsuits were filed by nearly 1,280 patient groups who claim that the medication caused the damage of their jawbone tissue. This latest judgment in favor of the woman patient mentioned above is a very important verdict in Fosamax lawsuits.
A recent study, conducted by the American Bone & Mineral Research, concluded that 94% of patients suffering osteoporosis also suffer a rare femur fracture and was traced back to the use of bisphosponate drugs such as Fosamax. A lot of the cases, as shown by the report, say that many of the fractures occur when patients were simply doing low-impact tasks such as walking down a flight of stairs. These reports on people with complaint about femur fracture, at the same time were also Fosamax users, started to come out as early as 2007. A report published in The Journal of Bone and Joint Surgery appeared in the same year. It featured 13 women with low-trauma leg fractures, 9 of whom were long-term Fosamax users.
In Canada, class action lawsuits against Fosamax manufacturer have already popped up. And recently, the Fosamax lawsuits win against Merck may open more doors for major class action lawsuits in the United States. Mostly, patients filing Fosamax lawsuits are claiming that the drug, a prescription treatment used to treat and prevent osteoporosis by increasing bone density and strength, has turned out to actually deteriorate bones. The condition caused a condition known as osteonecrosis of the jaw (or death of jawbone tissue) and contributes to femur fractures. On its part, the manufacturer denies such claims and says that Fosamax is a reliable and efficient prescription medication.
The U.S. Food and Drug Administration (FDA) contacted, in 2008, Merck & Co. Inc., concerning reports of femur fractures associated with their product, Fosamax. Nonetheless, announcement by the FDA was only made in October 2010 that it would require the makers of bisphosphonates to include the risk of femur fracture to the drug’s labeling and a provision for patients on medication guide concerning its risks.
Usually, Fosamax is prescribed to patients in treating menopausal osteoporosis. Moreover, Fosamax has been the subject of so much investigation as of late and is known to be included in a pharmaceutical category called bisphonates. It means that drugs under this category have been linked to thigh fractures. Worse, the drug has been said to cause other serious side effects.
If you are considering filing a lawsuit against Fosamax manufacturer, access valuable information from Fosamax lawsuit information center online.
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04/01/2012
Avandia Lawsuits Gain Support From FDA’s High Level Warning on Avandia
An oral diabetes medicine, Avandia or rosiglitazone, is used to control blood sugar levels
for people with type 2 (non-insulin-dependent) diabetes. Sometimes, it is used in combination with insulin or other medications, though it is not for treating type 1 diabetes. A drug site, however, specifically mentioned that Avandia is not recommended for use with insulin.
In quick layman’s term, Rosiglitazone (a thiazolidinedione) use results in reduced glucose, fatty acid, and insulin blood concentrations, thus, helping diabetic individuals with type 2 diabetes as it decreases cell resistance to insulin.
Unfortunately, the benefits that could be had from taking Avandia are not without risks. Taking the drug under alert increase the risk of serious heart problems, such as stroke or heart attack. The drug is, therefore, specified only for certain people with type 2 diabetes whose condition cannot be regulated by other diabetes medications.
The medicine’s manufacturer, GlaxoSmithKlein, reported a record sales from the drug that reached $3.2 billion in 2006. From then on, various controversies have risen and eroded consumer confidence in the drug, resulting in reduced sales. The government food and drug watchdog, the FDA, released a high level warning in 2007 that placed on Avandia a “black box warning” – a high level warning. This was followed by an FDA restriction in September 2010, making Avandia available only to individuals whose physician could expressly say that no other alternative medicine or therapy is available for the patient. On the other hand, the European Medicines Agency has put a stop on the sales of all rosiglitazones, and required the removal of Avandia’s from the market.
Why the restrictions on Avandia?
As was mentioned above, it has been found that Avandia increases the risk of serious heart problems.
Specific precautions are found online saying that Avandia should not be prescribed to type 1 diabetics, or if the patient is in a state of diabetic ketoacidosis. Additionally, before taking Avandia, individuals should declare to an attending physician their heart condition and history of heart attack or stroke such as congestive heart failure or heart disease, as well as liver disease, or eye problems resulting from diabetes.
It was also noted that a number of women using Avandia have begun having menstrual periods, despite not having one for quite a span of time because of a medical condition. Women patients who take Avandia are also more likely to have upper arm, hand, or foot bone fractures. Because of these risks, patients who are taking Avandia must see their doctor for proper evaluation.
In the legal standpoint, there is a legal case that could be raised in situations where Avandia has or is starting to affect the lives of its users. As a matter of fact, about 13,000 cases have already been filed against the manufacturer GlaxoSmithKlein.
It is not enough to simply seek health assistance for having damages wrought by taking Avandia. An individual should uphold his/her legal rights as a protected consumer. More on this at some online Avandia lawsuits information center.
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CellCept Lawsuits: A Run-Down On A Drug's Many Side Effects
Manufactured and sold by Switzerland’s pharmaceutical giant Hoffman-La Roche to hamper kidney, liver, and heart rejection after transplant procedures, CellCept is the brand name for mycophenalate motefil. This immunosuppressant drug works by stopping the immune system from attacking transplanted organs. This is possible by the drug’s action on white blood cells, lymphocytes, as these defense cells target foreign cells from transplant organs for termination. In May 1995, the FDA approved CellCept in 250 mg oral capsules. It is usually prescribed in combination with cyclosporine and corticosteroids.
However, this drug’s potent feature is also its risk because an immunosuppressant decreases the body’s ability to protect itself against microbes that could cause multiple numbers of infections. CelCept does not totally remove the body’s immunity though, as it does not hinder other white blood cells from doing their job. Other than its primary indication, CelCept is also used in controlling an overactive immune system.
As Mycophenolate decreases the body's immune system, it may also increase the risky development of lymph node tumors, a.k.a lymphoma, and other types of tumors. Further, another CelCept risk worth noting is its harmful effect to an unborn baby, especially if taken during a pregnancy’s first trimester.
Considering all these risks, it can be surmised that using CellCept can make it easier for a patient to bleed from an injury. With a weakened immune system, an individual can get sick just by being around others who are ill. Eventually, an individual may also have an increased risk of cancer.
CelCept has been a successful money-maker for Hoffman-La Roche. But after so many controversies in regard to CellCept’s risky side effects consumer confidence on the drug has been shaken. As of this writing, a CellCept warning has been raised but a resulting recall has yet to be effected. Legal groups have been considering filing a CelCept class action lawsuits against the manufacturer.
If you think that you and your loved-ones have been taking CelCept, heed the warnings. More information can be found in some online CelCept lawsuits information center.
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03/28/2012
Fosamax Lawsuits: When An Osteoporosis Treatment Causes Bone Damage
Fosamax is a biphosphonate drug that was discovered and marketed by pharmaceutical powerhouse Merck & Co. Fosamax (Fosamax+D has vitamin D additive) is the brand name for alendronate sodium or alendronic acid. The drug was used to treat osteoporosis and Paget’s disease. Merck’s patent for the drug expired in 2008. However, as the company’s raised legal efforts to stop the manufacture of its generic version, Barr Pharmaceuticals went ahead and came up with Fosamx’s generic type. It should be noted that before it lost its patent, sales figures for 2007 showed that Merck raked in $3 billion dollars from the drug’s sales; a convincing indication that the drug has been sold to millions.
Fosamax was prescribed to women who are in post-menopausal stage and men who are suffering from osteoporosis. The drug works by reducing bone degeneration, also known medically as “resorption.” However, the drug does not inhibit bone mineralization but one can accordingly see mineralization only when the drug is taken with supplements calcium and vitamin D. Furthermore, the drug is not absorbed quite well by the human body and, thus, the kidneys dissipate it. Additionally, the drug must be taken on an empty stomach for the drug to take effect.
Unfortunately, Fosamax causes health threats that were once unknown to its users. Reports of esophageal ulceration started to come forth. In this condition, treatment requires intensive treatment and hospitalization. Moreover, gastric and duodenal ulceration were also reported. As a matter of fact, the FDA reported that alendronate and related drugs cause esophageal cancer. Other general side effects reported are skin rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis, eye problems such as uveitis and scleritis. Reports also include generalized muscle joint and bone pain. In addition to the threat of cancer, just as traumatic was Osteonecrosis of the Jaw ONJ or the deterioration of the temporomandibular joint. It occurs when dental work on a Fosamax user is performed. Also known scientifically as “bis-phossy jaw”, ONJ is a disfiguring bone disease that is painful to people’s jaw bones, specifically the area of the mandible and maxilla.
The side effects mentioned above can be become worse as more reports on Fosamax’s devastation kept coming in. It is, therefore, highly advisable that further readingz on consumer rights and further health threats should be done by accessing more information at some online Fosamax lawsuits information center.
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Boniva Lawsuits Illustrate How the Drug Can Cause Many Side Effects
An online publication said that, in using Boniva, “side effects do occur, in most cases, they are minor and either require no treatment or can easily be treated by you or your healthcare provider.” However, medications were meant to alleviate an individual’s suffering, not prolong or add further discomforts to users. Besides, the first maxim that a medical practitioner has to learn in med school was, “First, thou shalt not hurt.”
Thorough studies have been conducted on Boniva’s side effects involving two sets of groups: a group of individuals under Boniva medication with documented side effects and another group not taking the medicine. In such way, it is possible to conclude what side effects occur, how often the occurrence is, and how Boniva users stand in comparison to the group not taking the medicine.
The following side effects were, thus, observed:
• Backpain
• Indigestion or heartburn
• Bronchitis
• Arm or leg pain
• Abdominal pain or stomach pain
• Diarrhea
• Headache
Other common Boniva side effects were observed: infections, weakness, vomiting, high cholesterol, muscle pain, arthritis, dizzinis, vertigo, pneumonia, sore throat, bladder infection or urinary tract infection (UTI), constipation and insomnia.
Consider the following testimonial of a patient under Boniva medication:
“Have not felt well since I started taking boniva. Flu like symptoms from the first pill. Next month took double the amount of water. However, extreme fatigue, body aches continued. Stopped taking it in March 2011. Experience fatigue an depression, weight gain and constant pain in leg muscles and shoulders. Difficulty walking, popping and cracking sounds from legs and shoulders when I get out of bed. Pain in upper legs makes it difficult to sleep on either side. Thought that symptoms would lessen after not taking drug but they seem to worsen. Now experiencing burning in legs.”
On the contrary to the above allegation that Boniva’s side effects can be minor, as a biophosphanate, Boniva can cause osteonecrosis of the jaw (ONJ) if taken by cancer patients. ONJ is a disease characterized by a painful bone damage affecting the jawbones—specifically, the mandible or lower jawbone, and maxilla, the upper jaw bone. Thus, in 2010, the FDA issued a Boniva warning. Nonetheless, neither Hoffman-LaRoche nor GlaxoSmithKline issued a recall.
One should not wait for their condition to worsen. Those who are taking Boniva should consult their physician and take legal advice as well. Further information are found in some online Boniva lawsuits information center.
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Most Current Updates on Possible Fosamax Lawsuits
A most recent femur fracture warning by the FDA is reflected in the labeling change and Medication Guide for Fosamax, Fosamax Plus D, as well as their generic counterparts.
The U.S. Food and Drug Administration (FDA) on October 13, 2010, released a femur fracture warning that informs patients and health care professionals on possible risks pertaining to atypical thighbone (femur) fractures in patients who are under bisphosphonates, such as Fosamax, medication. Bisphosphonate is a drug that is used for the prevention and treatment of osteoporosis. Atypical femur fractures, a rare but serious condition of the thighbone, have been reportedly prevalent in patients under biophophanate, such as Fosamax, medication for longer than five years.
In regard to this femur fracture warning, the FDA says that the agency is “continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment.” The statement further say that “In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”
The ongoing femur fracture warning follows a Drug Safety Communication dated March 10, 2010 that announces the FDA’s current safety review of bisphosphonate use and the occurrence of atypical femur fractures among its users. The FDA has so far reviewed all available information on bisphosphonate use. The summation includes data summarized in the report released by American Society for Bone Mineral Research Task Force. The report recommends further product labeling, better identification and tracking of patients experiencing these femur fractures, and further research to assess whether and how these drugs correlates to the serious, yet uncommon, fractures.
Based on the FDA’s review, the Warnings and Precautions section of all bisphosphonate products for osteoporosis, including Fosamax, will be revised to include the femur fracture warning, and the FDA will require the inclusion of the same femur fracture warning into a Medication Guide to better inform patients of the possible increased fracture risk.
With this latest femur fracture warning, the FDA is recommending that health care providers be updated on the possible risks patients are faced in taking bisphosphonates and consider regular reevaluation of the necessity for continued bisphosphonate treatment for patients who have been on bisphosphonates for longer than five years. Otherwise, resulting injuries may raise possible Fosamax lawsuits.
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Darvon & Darvocet Lawsuit: Stop Pain, Not the Heart
In 1957, propoxyphene was granted FDA approval for marketing under the name Darvon in 1957 for Eli Lilly and Company. The prescription medication is prescribed for mild to moderate pain. At the time, the product was cause for celebration in the pharmaceutical industry as it was a better medium than aspirin which was thought to be relatively weak. It was also a better alternative for narcotics such as morphine and codeine as these were dangerous to some patients and can be very addictive. In 1972, Darvocet, which also contains the pain reliever and fever reducer acetaminophen and propoxyphene, was approved by the FDA.
Propoxyphene is classified as synthetic opioid analgesic. Natural opiates are taken from the poppy plant while synthetic versions, though containing a similar chemical structure are rather created in a laboratory. Opiates works in reducing pain as they attach to receptors in the central nervous system. In doing so, they block pain messages to the brain, inducing a relaxed, euphoric state in the process. Now, since users develop tolerance to the effect of propoxyphene, as a narcotic pain reliever (induces drowsiness), and consequently need a higher dose to gain the same effect. Yet, it is of lesser potency than other narcotics (morphine, OxyContin, and Percocet), making it less subject to abuse. It is also recommended for those having allergic reactions to more powerful narcotics.
Statistic data can estimate that prescriptions for the product containing propoxyphene can reach up to 600 million prescriptions since the drug was released in the market more than 50 years ago. In 2007 alone, more than 20 million (over 10 million in 2009) propoxyphene prescriptions have been dispensed making it one of the most popularly prescribed drugs in the United States.
Xanodyne Pharmaeuticals, Inc. On November 19, 2010, abided with a U.S. Food and Drug Administration (FDA) recall request of Darvon and Darvocet. The request resulted from the FDA’s consideration of clinical data which points to the opiod propoxyphene being linked to arrhythmia, a potentially fatal heart rhythm abnormality. The request also applied to generic manufacturers of propoxyphene.
In a statement revealing their research findings, John Jenkins of the FDA’s Center for Drug Evaluation and Research expressed that “We concluded that the pain-relief benefit no longer outweighed the health risks.” Suffice to say that the primary problem with the drug is that the risk for heart arrhythmias occurs in healthy patients, even those who are taking prescribed dosages. As propoxyphene affects the heart’s electrical activity, the result can be fatal. A reassuring news though is that ending the use of the medication means ending the risk.
For further information on where the durg’s recall stand, consult the Darvon and Darvocet lawsuit information center.
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