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Safyral Lawsuit News

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Safyral Lawsuit News (01/24/2012)   Adverse events associated with many oral contraceptives, such as Safyral, are numerous, and those individuals who have suffered because of these side effects should consider a Safyral Lawsuit to recover any losses.  In May of 2011, the U.S. Food and Drug Administration released information regarding the possibility of an increased risk of blood clots for patients using birth control pills that contain drospirenone.  Blood clots can lead to deep vein thrombosis, pulmonary embolism, heart attacks and stroke.  To find out if you might be eligible for compensation via a Safyral Lawsuit, complete the form to the right or call Best Legal Source at 800-611-7080.   We will help connect you with a Safyral Lawsuit attorney qualified in filing Safyral Lawsuits.

1-800-611-7080

 

Since not all attorneys have the experience necessary to successfully file Safyral Lawsuits, it is advisable to hire a Safyral Lawsuit attorney with the knowledge needed to get the best results.   If your case has merit, they will fight to assist you in obtaining the financial compensation you deserve for your medical costs as well as physical and emotional pain.  Therefore, if you have developed blood clots after using the drug Safyral, Best Legal Source can help you find a qualified legal representative to file your Safyral Lawsuit.

To avoid any consumer confusion, our use of the words  Safyral Lawsuits or Safyral Lawsuit attorney in no way indicates, implies, or insinuates any relationship or affiliation between Best Legal Source and the manufacturers of Safyral.  They are used for descriptive purposes only.  This website is intended to assist individuals who believe their injuries are a direct result of taking Safyral.

If you or a loved one took the birth control drug Safyral and suffered from any of its side effects, you may be entitled to seek compensation through a Safyral Lawsuit for damages as well as your pain and suffering from any injuries.  Call Best Legal Source and you will be connected with an experienced Safyral Lawsuit attorney to ensure you recover the maximum amount of compensation available.   Remember to simply fill out the form located to the right or call Best Legal Source at 800-611-7080.

 

1-800-611-7080

Safyral Lawsuit : Information from the FDA

 

Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots

On May 31, 2011, the U.S. Food and Drug Administration (FDA) informed the public about new information that is being assessed as part of FDA’s ongoing safety review of birth control pills containing the progestin hormone drospirenone. Two recently published studies report that there is an increased risk of deep vein thrombosis (DVT) and pulmonary embolus associated with the use of birth control pills containing drospirenone compared to the risk associated with the use of birth control pills containing a different progestin hormone (levonorgestrel).1, 2

DVT is a rare condition in which blood clots form inside a vein, most commonly in the legs. A blood clot can break loose, move through the body to the lungs, and cause a serious, potentially fatal, problem called a pulmonary embolism (PE).3

The following questions and answers provide an overview of this potential safety issue.

Q1. What is drospirenone?

Q2. Which oral contraceptives contain drospirenone?

Q3. What is a deep vein thrombosis (DVT) and pulmonary embolus (PE)?

Q4. What is already known about combination birth control pills and the risk of venous thromboembolism (VTE)?

Q5. Why is FDA further reviewing the risk of venous thromboembolism (VTE) and birth control pills containing drospirenone?

Q6. How is FDA evaluating these conflicting study results regarding the risk of venous thromboembolism (VTE) in users of oral contraceptives containing drospirenone in order to decide if any regulatory action is needed?

Q7. What should women do if they are currently taking birth control pills containing drospirenone?

Q8. Are there women who should not take birth control pills, particularly those containing drospirenone?

Q9. Has FDA communicated to the public about this issue before?

Q10.What are European regulators doing about birth control pills containing drospirenone?

 

Q1. What is drospirenone?

A. Most birth control pills (combination oral contraceptives) combine a synthetic version of the female hormone progesterone (referred to as a progestin) with a synthetic version of the female hormone estrogen. Drospirenone is one of several different progestins that are used in birth control pills.

 

Q2. Which oral contraceptives contain drospirenone?

Birth control pills containing drospirenone include: Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Some birth control pills containing drospirenone are also approved to treat symptoms of premenstrual dysphoric disorder (PMDD), to treat moderate acne, and to raise folate levels, in women who choose to use an oral contraceptive for contraception.

 

Q3. What is a deep vein thrombosis (DVT) and pulmonary embolus (PE)?

A. Deep vein thrombosis (DVT) is a rare but serious condition where a blood clot forms inside a vein. These blood clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs. If the clot travels to the lung, it is called a pulmonary embolism (PE), a potentially fatal condition where an artery in the lung becomes blocked.3 DVTs and PEs are also called venous thromboembolic events, or VTEs.

The symptoms of a DVT include the new onset of persistent leg pain, while those of a PE include severe chest pain, and sudden shortness of breath. Women experiencing these symptoms should contact a healthcare professional immediately because VTEs can be life-threatening.

 

Q4. What is already known about combination birth control pills and the risk of venous thromboembolism (VTE)?

A.VTE is already known to be a rare but serious potential side effect of taking any birth control pill containing a progestin and estrogen. The risk of VTE in users of birth control pills is low, although it is higher than the risk of VTE in women who do not take birth control pills. The risk of VTE in pregnant women (about 5 to 20 cases per 10,000 women) 4 is even higher than that in women who take birth control pills.

The drug labels for all combination birth control pills include warning information on the potential risk of VTE and describe additional factors that increase this risk. The risk of VTE associated with birth control pills increases as a woman gets older and is also higher in women who smoke. Usually the risk of VTE is highest during the first year after starting to use a combination birth control pill.

 

Q5. Why is FDA further reviewing the risk of venous thromboembolism (VTE) and birth control pills containing drospirenone?

A. FDA is aware of two newly published studies that evaluated the risk of VTE in women who use birth control pills that contain drospirenone.

The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel.1-2 These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills.

Conflicting information already exists on this potential increased risk. Two previously published studies, which were conducted at the request of FDA or the European regulatory agencies after drug approval, did not report any difference in risk of VTEs between the drospirenone-containing product and products containing levonorgestrel or other progestins.5, 6 However, two publications in 2009 reported that the risk of VTEs is higher in women using a drospirenone-containing product than in women who use levonorgestrel-containing products. 7, 8 These four earlier studies are already described in the labeling for drospirenone-containing birth control pills.

FDA is currently evaluating all available information to assess fully the VTE risks of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.

 

Q6. How is FDA evaluating these conflicting study results regarding the risk of venous thromboembolism (VTE) in users of oral contraceptives containing drospirenone in order to decide if any regulatory action is needed?

A. FDA is thoroughly reviewing the two recently published studies, which includes evaluating the strengths and weaknesses of the epidemiologic methods used in these two studies as compared to those used in the other published studies. FDA’s overall assessment of VTE risk for drospirenone contraceptives will be based on the strength of the scientific evidence from each of the studies. Data from an additional, large, FDA-funded, study on hormonal contraceptives is also being finalized and reviewed. This study includes over 800,000 US women and is designed to look at thrombotic and thromboembolic risks including VTE in a number of hormonal contraceptive products; results are expected later this summer.

 

Q7. What should women do if they are currently taking birth control pills containing drospirenone?

A. Women taking birth control pills containing drospirenone should continue taking their pills as directed unless told otherwise by their healthcare professional. Women should know how to recognize the symptoms of VTE and should contact their healthcare professional immediately if they experience persistent leg pain, severe chest pain, or sudden shortness of breath. Women should also discuss any questions or concerns about their use of combination birth control pills with their healthcare professional and report any side effects to the FDA MedWatch program using the “Contact Us’ information at the bottom of the page.

 

Q8. Are there women who should not take birth control pills, particularly those containing drospirenone?

A. Women with certain conditions or risk factors should not use any combination birth control pill. FDA recommends that women who are over age 35 and smoke should not take any type of combination birth control pill (including those containing drospirenone), due to an increased risk of serious cardiovascular events. The risk of VTE also increases with age and smoking. Women with a history of blood clots, heart attack, or stroke should not take combination birth control pills. Additionally, women who are pregnant or think they may be pregnant should not use combination birth control pills.

Because drospirenone, in contrast to other progestins used in combination oral contraceptives, has the potential to increase serum potassium levels, women with renal or adrenal disease should not use birth control pills containing drospirenone.

For additional labeling information on all combination birth control pills, visit Drugs@FDA1.

 

Q9. Has FDA communicated to the public about this issue before?

A. FDA has included warning information about the risk of VTEs in the labels of all combination birth control products. FDA has also communicated previously about the potentially greater risk of VTE with drospirenone-containing birth control products. This prior communication can be found on the Agency’s website:

 

Q10. What are European regulators doing about birth control pills containing drospirenone?

A. The European Medicines Agency (EMA)3 has decided to update the product labeling for oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing. They have concluded that the risk of VTE for drospirenone-containing birth control pills is higher than that for levonorgestrel-containing pills, but that the risk of VTE with any birth control pill (including those with drospirenone) is very small and that there is no reason for women to stop taking drospirenone-containing birth control pills.

Because FDA’s review of these new data is still ongoing, we are issuing a Drug Safety Communication to alert patients and healthcare providers about this new information that is being assessed as part of our ongoing safety review. Labeling for these products currently describes the previously published studies, which provided conflicting results regarding whether the risk of VTE is higher for women who use birth control pills that contain drospirenone. Upon completion of our review, FDA will provide patients and healthcare providers with appropriate information about VTE risk, including a possible update to labeling, for drospirenone-containing birth control pills.

 

 

 

 

Safyral Lawsuit

Safyral LawsuitKeyword Contact Page

Safyral Lawsuit Contact Page
1-800-611-7080

 

Safyral Lawsuit News – 2/2/2012: If you were prescribed Safyral and have suffered negative side effects, please contact us today so that we can put you in touch with an attorney to advise you of your legal rights.

Safyral LawsuitConsistent with the deeply frustrating nature of this disease, inter­stitial cystitis causes a number of bladder symptoms that can vary from person to person and may even vary in the same individual from time to time. Many women tell us that the symptoms of IC become much worse before their periods. The unpredictability and inconsistency of symptoms make IC difficult to diagnose. That fact has likely contributed to women hearing doctors say, “It’s all in your head” instead of the longed-for “Here’s what we can do to help.” By the time the diagnosis is made, most women with IC have had symptoms for longer than six months, and some for years. That can add up to a lot of suffering and discomfort without even the limited comfort of a diagnosis, let alone treatment.

Most women name bladder discomfort as the most common symptom, and many feel pressure, tenderness, or even intense pain. Women often report the discomfort near the pubic area, where the bladder is located, or near the vagina or the inside of the thighs. Other women experience low back pain as a result of IC. Most women report that the discomfort is usually worse when their bladder is full. They also feel blessed, but brief, relief after uri­nating. Because the bladder sits right on top of the vagina, many women with IC have pain with intercourse. Many women with IC need to urinate frequently (frequency) and often experience a tremendous urge to urinate despite the fact that their bladder is nearly empty (urgency).

Most women urinate six to eight times a day, women with IC pass small amounts of urine approximately sixteen times a day. Need­less to say, these women spend a lot of time thinking about and get­ting to a bathroom. Almost all women with IC need to get up in the middle of the night more than once to go to the bathroom. As the condition gets worse, this need increases. Many women with IC have the sense that they do not fully empty their bladders, even though the bladder is, in fact, empty. Some women find that the urinary stream starts and stops intermittently without much con­trol on their part.

Current figures estimate the number of people in the United States with IC to be as many as 700,000. Ninety percent of people with this condition are women. The average age of women diag­nosed with IC is about forty-five, although a few are diagnosed in their late teens. For reasons we don’t yet understand, Caucasian women are more likely to have IC than African-American or Asian women, and Jewish women are four times as likely to have IC than non-Jewish women. In addition, women with diabetes appear to be at greater risk.

We really don’t know. Scientists and physicians have proposed sev­eral theories, but the truth is that we still don’t know. Because IC often feels like an acute bacterial bladder infection, one theory sug­gests that IC may start with such an infection. That theory pro­poses that an inappropriate immune system response to the initial infection results in the patient’s own immune system attacking and injuring the lining of her bladder, leading to the chronic symptoms.

Safyral Lawsuit News: Additional Information and Resources

Safyral Lawsuit:  Another theory links IC with the bladder lining cells that pro­duce mucus that coats and protects the cells from the irritating effects of the normally acidic urine. Researchers have identified substances that interfere with the production of this mucus and found that they can produce the symptoms of urgency and fre­quency just like IC. Yet another theory suggests that an abnormal bladder lining may allow irritating substances to pass into the cells easily and cause the symptoms of IC. Other doctors believe that foods that contain high levels of potassium or are high in add can cause irritation to the bladder lining in susceptible women. Still others feel that IC may be a condition ofthe bladder similar to food allergies. While IC has been seen in some mothers and daughters and ethnic groups, a specific genetic link has not been found.

Unrelenting pain that is not easily diagnosed and cured can lead to depression. While antidepressants can alleviate the depression and make the patient feel better, they don’t address the cause of the pain. Also, high levels of stress often decrease the brain’s tolerance for pain and may make the IC worse. Stress may not cause IC, but stress reduction techniques (see page 169} can often help reduce its symptoms. Unfortunately, there is no test that definitively diagnoses IC. A di­agnosis is based on the presence of a combination of symptoms (as described on page 154) without any other definite or obvious cause. Before making the diagnosis of IC, other conditions that can affect the bladder have to be considered and excluded. Those include the following: bladder infection, vaginal or urethral infection, bladder cancer, radiation changes to the bladder, allergic cystitis, bladder stones, endometriosis, ovarian or uterine growths, neurological disorders, and sexually transmitted diseases.

Urethral cultures for unusual organisms and complete vaginal and bladder cultures should be performed. Usually the doctor wants to see you a few times when you are having symptoms and repeat the cultures to make sure they are negative before the diag­nosis of IC is even considered. Doctors usually ask their patient to keep a written record, called a bladder diary, of how often they uri­nate and when pain occurs. This record confirms that urinary fre­quency is present. At the end of the cystoscopy and while you are still under anes­thesia, the doctor can overfill and stretch the bladder with water (hydrodistention). The water is held inside the bladder for a few minutes and let out. In about 80 percent of women with IC the hy­drodistention will cause pinpoint bleeding areas on the bladder lining, called glomerulations. This may cause a very small amount of blood in the urine for a few days that then goes away. Glomeru­lations are not always seen and are sometimes found in women who do not have IC. So this test is not foolproof either.

A biopsy of the bladder lining is sometimes necessary during the cystoscopy, especially if the diagnosis is not clear or, rarely, if there is suspicion of bladder cancer. A pathologist then examines the small sample of lining cells under the microscope. If IC is present, the biopsy may show thinning or even the absence of lin­ing cells, or it may show changes in the cells that typically occur with an immune response. However, a bladder biopsy is not usu­ally needed to diagnose this condition.

Safyral Lawsuit News: News and Information from related Sources

Safyral Lawsuit : Urodynamics testing  may also help make the diagnosis of IC. When the bladder is filled with sterile water dur­ing the UDS, women with IC usually have a sensation of die blad­der filling much sooner than healthy women would. This early sensation of bladder filling is called sensory urgency, a clear sign of IC. While the patient feels this sense of urgency, there are no er­rant bladder contractions seen during UDS testing. This helps to distinguish women with IC from women with overactive bladders. Another clue found during UDS testing is that the bladder holds only a small amount of water. As mentioned before, women with IC often cannot hold more than 8 ounces in their bladder. Another test to help diagnose IC is called the potassium chloride test. While the patient is awake, a solution of the salt potassium chloride is introduced into the bladder through a catheter.

Though there axe a number of treatments available to treat IC, none of them is universally effective. Bladder training, hydrodis­tention, dietary changes, medications, pain management, and sur­gery all have a place in the treatment of women with IC. Each of these treatments is described below. It is best to seek treatment early on because if symptoms have been present for more than a year, the treatments are sometimes less effective. Further research into the causes of and treatments for IC is under way, and we’re op­timistic that doctors and patients will soon have more treatment tools at their disposal.

Bladder training can be very helpful for women with IC. Begin by keeping a written record of how often you urinate and how often you feel pain over the next two days. You may mod­ify the voiding diary by substituting “pain” for “accidents.” Next, calculate the average time between voidings. The following day, add fifteen minutes to the average interval and delay going to the bathroom until that much time has passed since you last made a trip. If you get a strong urge to void, use Kegel contractions or re­laxation techniques to delay your next trip to the bathroom until you reach your goal. Each week another fifteen minutes is added to the time between trips until a comfortable schedule is reached. This approach requires patience. It may take a few months to sig- nificandy reduce urgency and frequency.

Some women notice that acidic foods increase the symptoms of IC. A low-acid diet (i.e., avoiding citrus, apples, grapes, tea, toma­toes, and peppers) will often help moderate the symptoms of IC. Also, frequent sips of water will help to dilute irritants and acid in the bladder. However, drinking more than four glasses of water a day may lead to more frequent urination and make the symptoms worse. Calcium citrate, 1,200 to 1,500 milligrams daily, can also help counteract the acidity in your diet. Citrate neutralizes acid in the urine. As an added benefit, the calcium in the pills helps to build your bones. Potassium citrate tablets, 10 milliequivalents three times a day, may also be used to counteract acidity in the bladder.

The medications used to treat IC are administered in two ways: orally (you swallow them) or as solutions placed directly into the bladder (see below). The only oral medication that has shown the effectiveness required to get FDA approval for IC is called Elmiron (pentosan polysulfate). This medication is taken three times a day. How Elmiron helps IC is not clear, but researchers think it repairs the defects in the cells of the bladder that allow the lining to be­come irritated by the acidity of urine. It takes at least three months before patients experience relief from Elmiron. We recommend sticking with it for six months before giving up on it. If it is effec­tive, patients continue Elmiron for at least one year. Less than 5 percent of women who take the drug will experience side effects, including stomach discomfort and minimal hair loss. Any hair lost during treatment will grow back after the medication is stopped.

Safyral Lawsuit News: Information and News

Safyral Lawsuit:  Atarax (hydroxyzine) works well for women who have an in­crease in pain associated with their menstrual periods. This in­creased pain is thought to result from an increase in histamine production during that time. Atarax is an antihistamine that can be taken orally to counteract that increase. This medication should also be tried for at least three months. Elavil (amitriptyline) was de­veloped as an antidepressant, but low doses of it and other antide­pressants have been found to be helpful for patients with chronic pain of any type. Neurontin was initially used for treating epilepsy, but this drug has also been effective in treating chronic pain syn­dromes, and it helps some IC patients. L-arginine, an amino acid, and Cytotec, an antiulcer drug, have also been helpful to some IC sufferers. Often doctors combine several of these medications to get a better effect. Tagamet is an over-the-counter medication developed to pre­vent excess stomach acid. Prelief is an over-the-counter antacid that can be used prior to a meal to decrease stomach acidity. Some women with IC notice an increase in symptoms when they eat acidic foods. These medications help neutralize acids that eventually end up in the bladder.

Medicated solutions placed into the bladder through a catheter are also used to treat IC. First, the medication is mixed with a sterile solution. A very small catheter is inserted into the bladder and a small syringe filled with the medicine is attached. The syringe pushes the medicine into the bladder and the patient holds the solution there for as long as prescribed. This process is called a bladder instillation. Usually the solution contains a local anesthetic, so the pain relief is often immediate. Most women eas­ily learn to do this at home, and the whole process takes about fif­teen minutes.

The only FDA-approved medication for bladder instillation is DMSO (dimethyl sulfoxide), which is effective in about 40 percent of women with IC. Although we don’t know exactly how it works, it does reduce bladder inflammation. Instillations need to be done for fifteen minutes weekly for six to eight weeks. The benefits of DMSO can last six months or so. Patients do the instillations at home, and the side effects are minimal. Some patients notice a garlic-like taste in their mouths after the instillation. When tested in animals, long-term use of DMSO has been shown to cause cataracts, although we haven’t seen this in people. Anyone using DMSO should see an ophthalmologist every six months for a checkup just to make sure.

Heparin, a commonly used blood thinner, has also been used as a solution for instillation into the bladder. Heparin is similar to Elmiron and may also act to repair the bladder lining. It is effective in about 50 percent of women. Heparin is often combined with a local anesthetic and held in the bladder for about two hours to give relief of bladder pain. Unfortunately, each instillation provides re­lief from discomfort for 110 more than a day or so, and instillations need to be repeated five to seven times a week. It may take three to six months of weekly instillations to see any improvement and one to two years before major improvement. BCG (bacillus Calmette- Guerin), a bacterial vaccine used to immunize against tuberculo­sis, can be mixed with a solution and also used for bladder instillations. It has shown promising results in treating IC.

Safyral Lawsuit News: News and Information

Safyral Lawsuit:  Despite the fact that there is no known cure for IC, most patients get some relief from medications, distillations, and bladder train­ing. Less than 10 percent of patients ultimately choose surgical treatment In women who have Hunner’s ulcers in the bladder, electricity or a laser can be used during the cystoscopy procedure to destroy the ulcers, leading to significant improvement. Severe IC can cause the bladder to become scarred and very small. A procedure called bladder augmentation can be performed to add to the storage area for urine. During this procedure the sur­geon removes a piece of the patient’s intestines and sews it onto the bladder. This increases the size of the bladder. However, be­cause a portion of the bladder itself is left in place, some women may continue to have bladder irritation and continued pain.

Cystectomy, the removal of the entire bladder, is a fare last re­sort. The surgeon takes a portion of the woman’s intestines and makes a pouch inside the body that holds her urine. Obviously, only women who have exhausted all other alternatives and still have chronic pain consider this procedure. Some patients con­tinue to experience pain in the new pouch. The theory is drat die same defect of mucus production that is present in the bladder lin­ing probably also exists in the bowel lining cells, leaving them vul­nerable to injury from the urine. These women need to continue therapy even after surgery.

Due largely to the efforts of patients, IC has become the focus of re­search efforts by the federal government—the National Institutes of Health (NIH) and the National Institute of Diabetes and Diges­tive and Kidney Diseases (NIDDK). Drug companies and patient support groups also fund research. Hopefully, as has occurred with breast cancer and prostate cancer research, more attention from patients and doctors will encourage more funding. Increased funding will be necessary for research to help eluci­date the cause or causes of IC and determine which treatments are most effective. Both public education and medical education need to be expanded. We hope that increased awareness on the part of women and their doctors will allow earlier diagnosis and treatment and help prevent the progression of disease to the point where it is difficult to cure. Efforts are now being focused on how components of the urine or unusual infectious organisms may cause injury to the bladder. Hopefully, new treatment strategies will come from these research efforts.

Weak muscles and tom connective tissue show up well on MRI, and it is a very accu­rate way of detecting any damage to the supporting tissues as a re­sult of childbirth, trauma, or aging. The MRI research results show that women with prolapse and incontinence generally have unsus­pected damage to areas in the pelvis. We’ve learned a great deal from these MRI studies, and we are now better able to understand what needs to be done to correct these problems. At this point, MRI is very time-consuming, cumbersome, and expensive and is used primarily for research purposes, but the information from this research will help all women.

Our use of the term or terms Safyral Lawsuit is for descriptive purposes only. There is no relationship between the owners of this website and the maker of the product discussed in this post. Our use of the words Recall, Class Action Lawsuit and other similar words related to an event do not necessarily mean that this event has occurred. Refer to the website of the United States Food and Drug Administration for information on drug or medical device recalls. If a Class Action Lawsuit is formed in relation to the product discussed in this post we will provide that information at the time the Class Action is formed. A Class Action Lawsuit is not required to exist for you to file a lawsuit if you have been injured by the product discussed in this post.

To keep up to date on Safyral Lawsuit  visit our site often.

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