Ocella Lawsuit

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Ocella Lawsuit News (1/24/12): Recently, the FDA released a safety message for all birth control pills with the ingredient of drospirenone. The Ocella Lawsuit includes women who developed blood clots while they were taking Ocella. You might be interested in learning more about the Ocella Lawsuit news if you’ve had side effect such as persistent leg pain, severe chest pain or shortness of breath while taking this birth control. These are symptoms of a potential blood clot problem. Two recent studies found that women using drospirenone birth controls increased their risk of developing blood clots. Would you like to learn more about the Ocella Lawsuit? Call Best Legal Source at (800) 611-7080 or complete our form to your right. We will contact you and inform you of possible Ocella Lawsuit options.

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The potential Ocella Lawsuit covers serious issues. Blood clots have the possibility to increase your risk for other severe health problems. Strokes, heart attacks, pulmonary embolism and deep vein thrombosis have the possibility of occurring after you have developed a blood clot. Don’t wait to find out more about Ocella Lawsuits. You have some health risk if you are on a drospirenone birth control. We can help you find an Ocella Lawsuit attorney interested in your case.

An Ocella Lawsuit may be an option for you if your health was compromised by this drug. Best Legal Source can set up the first conversation with an Ocella Lawsuit lawyer. The call concerning an Ocella Lawsuit is free; you have nothing to lose. Call Best Legal Source today!

Ocella Lawsuit and Ocella Lawsuit lawyer are general words not meant to suggest Best Legal Source is the maker of Ocella. To be clear: Our goal at Best Legal Source is to provide access to Ocella Lawsuit lawyers for clients who had health complications after taking Ocella.

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Ocella 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.

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@FDA.

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:

MedWatch Alert: April 2010

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

A. The European Medicines Agency (EMA) 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.

Ocella Lawsuit

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Ocella Lawsuit News – 2/1/2012:

Please contact us today if you took Ocella and suffered unusual side effects or other injuries.

Ocella Lawsuit News: Additional Information and Resources

Ocella Lawsuit: Clinical evidence demonstrating anti-inflammatory and plaque-stabilizing effects of statin drugs has only recently become available. The first study to address whether patients with evidence of inflammation benefited from statin therapy was performed within the Cholesterol and Recurrent Events (CARE) trial, a secondary-prevention evaluation of pravastatin. Consistent with studies of primary prevention, participants in the CARE trial with elevated CRP levels were found to have higher risks of recurrent coronary events than those with lower levels of CRP. However, a clinically apparent interaction between statin therapy and inflammation was also observed in that the proportion of recurrent events prevented by pravastatin was 54% among those with inflammation compared with 25% among those without inflammation. Moreover, long-term therapy with pravastatin significantly reduced plasma levels of CRP in a manner that was not related to this agent’s effects on LDL cholesterol. In fact, in this hypothesis-generating study, there was no relationship between the change in CRP and the change in LDL cholesterol at the end of the 5-year follow-up period. Thus, these initial data provided clinical evidence that statin therapy may well have anti-inflammatory properties. While the mechanism of this effect is uncertain, the CARE data provide evidence for possible clinical relevance of laboratory observations demonstrating nonlipid effects of the HMG-CoA reductase inhibitors, such as modulation of immune function, antiproliferative effects on vascular smooth muscle, and antithrombotic properties, as well as morphological effects.

Two major studies have now addressed the validity and clinical importance of these observations. The first, the Pravastatin Inflammation/CRP Evaluation (PRINCE) trial, was explicitly designed to address three questions. First, can the effects of pravastatin on CRP observed in the CARE trial be confirmed in a direct hypothesis-testing setting? Second, how quickly does any effect of pravastatin on CRP occur and are the effects of pravastatin on CRP truly independent of changes in LDLC? And third, are the effects of pravastatin on CRP observed in CARE (a secondary-prevention study) equally present in primary- prevention populations? In total, the PRINCE trial evaluated 2884 patients: 1182 in a secondary- prevention cohort who received pravastatin 40 mg daily, and 1702 in a primary- prevention cohort randomly allocated to either pravastatin 40 mg daily or placebo. Prior use of lipid-lowering therapy within the previous 6 months was not allowed, and those in the primary-prevention arm had to have LDL cholesterol levels greater than 130 mg/dL. Blood samples were collected at baseline.

As ensured by the randomization process, baseline levels of CRP (median 0.20 mg/dL), total cholesterol (231 mg/dL), LDL cholesterol (143 mg/dL), and HDL cholesterol (40 mg/dL) were virtually identical in the two primary- prevention arms of the PRINCE trial. In contrast, compared with those in the primary-prevention cohort, those with a prior history of cardiovascular disease who were enrolled in the secondary-prevention cohort of PRINCE had significantly increased CRP levels (median 0.26 mg/dL). As would be expected, those in the secondary-prevention cohort were also older and more likely to smoke or have diabetes, and the group had a higher proportion of aspirin users than the primary-prevention cohort. During the course of the study, highly significant reductions in total cholesterol, LDL cholesterol, and triglycerides were observed in the pravastatin groups, as was a clinically important increase in HDL cholesterol (all p values <0.001). No change was observed in any of these parameters among those allocated to placebo.

Ocella Lawsuit News: More information about your search

Ocella Lawsuit: The main analyses of PRINCE were the effects of statin therapy at both 12 and 24 weeks. In the primary-prevention cohort, pravastatin reduced median CRP levels by 16.9% compared with placebo at the end of the 24-week study period (p < 0.001). This effect was present at 12 weeks (median reduction in CRP with pravastatin 14.7%; p < 0.001). As shown in Figure 7, these effects were observed in all the PRINCE prespecified subgroups, including analyses stratified by age, smoking status, gender, obesity, and lipid levels. As had been hypothesized, virtually no association was observed between CRP and lipid levels either at the study beginning or during follow-up. In fact, in correlational analyses, less than 2% of the variance in the change in CRP could be explained by the change in any lipid parameter. Virtually identical effects were also seen in those in the secondary-prevention cohort of the study.

Several decades ago, homocystinuria, a rare pediatric condition, was noted to be associated with musculoskeletal abnormalities and the development of venous thromboembolism and arterial disease in adolescence. The underlying metabolic defect for this condition was shown to be decreased enzymatic activity of cystathionine beta-synthase. This deficiency was associated with increased levels of methionine and homocysteine and a decrease in blood levels of cysteine. Later investigations of a patient with elevated homocysteine levels and similar clinical findings, but with a low concentration of methionine in the plasma and evidence of abnormal vitamin B₁₂ metabolism, led to the conclusion that another defect could account for elevated homocysteine levels and vascular disease.

A large variety of factors have been associated with increased levels of homocysteine, and only the key topics in healthy outpatients will be considered here. Fasting blood homocysteine concentrations are typically greater in the elderly compared with middle-aged adults, and higher in men than in women. Analyses of the Framingham Heart Study and the National Health and Nutrition Examination Survey data have shown that the prevalence of elevated homocysteine (>14 |j.mol/L) increases with age in both sexes, and plasma homocysteine levels are inversely correlated with vitamin intake. Vitamins Bj, B₂, B₆, B₁₂, folate, niacin, retinol, vitamin C, and vitamin E have all been studied, but the greatest interest has been shown for vitamins B₆, B₁₂, and folate, as these nutrients act as cofactors for several homocysteine metabolic pathways.

Low vitamin B₁₂ status can also account for elevated homocysteine levels, as this vitamin is a necessary cofactor in several homocysteine metabolic steps. Inadequate production of intrinsic factor in the stomach can result in a severe vitamin B₁₂ deficiency, with substantially elevated homocysteine concentrations, but this etiology is an infrequent cause of low vitamin B₁₂ status. Hypochlorhydria and achlorhydria are more common than inadequate intrinsic factor deficiency, especially in older individuals, and can lead to impaired absorption of vitamin B₁₂ because low pH is needed to dissociate B₁₂ from food.

Ocella Lawsuit News: News and Information

Ocella Lawsuit: There are many genetic causes of elevated homocysteine levels. Enzymatic defects and variants have been associated with cystathionine beta-synthetase, methylene tetrahydrofolate reductase (MTHFR), thermolabile and nonthermolabile variants, and methionine synthetase, to name a few. The MTHFR variant 677- C ^ T has gotten the most attention, as it is relatively common and affects 10 to 15% of North Americans and 5 to 25% of Europeans. This MTHFR variant has also been studied for associations with cardiovascular disease, and homozygosity has generally been associated with an increased occurrence of disease; however, several studies demonstrated no association between the MTHFR and vascular outcomes. A meta-analysis concluded that a modest association with increased risk for cardiovascular disease was present. The inconsistent association between MTHFR variants and vascular disease may be partially explained by population dietary data. Persons homozygous for MTHFR 677-C ^ T and who had suboptimal folate status were especially likely to have elevated homocysteine levels.

Other studies have not always corroborated these results. In some instances, the associations with adverse outcomes were demonstrated for nutrient status, but not for homocysteine levels. For instance, higher homocysteine levels were not associated with greater risk in a MRFIT-nested case-control analysis (20); the ARIC study demonstrated higher folate and B₆ intake to be associated with lower CVD risk but associations with higher homocysteine were not significant (21); and the Nurses’ Health Study investigators found that higher folate and B₆ intake was associated with lower cardiovascular risk. Elevated homocysteine concentrations in the plasma may potentiate thrombin generation and may have relevance in the setting of acute coronary syndromes. A study of approximately 100 persons with acute coronary syndromes was found to have positive associations with F1 + 2 and Factor Vila levels. It has been proposed that hyperho- mocysteinemia potentiates a procoagulant state that may adversely affect the endothelium and enhance tissue factor activity.

Large-scale interventional data that reduce homocysteine levels and demonstrate favorable effects on cardiovascular risk are lacking, but vitamin supplements are being included in a variety of ongoing studies and the results should be forthcoming. The minimal daily dose of folic acid that appears to have maximal efficacy to decrease plasma homocysteine is estimated as 0.4 ^g/day, with higher doses not generally being more effective. It is recommended that vitamin B₁₂ deficiency be ruled out prior to initiating folic acid therapy. Alternatively, persons on folic acid therapy can be supplemented with a dose of 400 to 1000 |J.g/day of vitamin B₁₂. The dose of vitamin B₆ recommended was 25 to 50 mg/day and there is little risk of developing complications such as sensory neuropathy at this supplement level.

Ocella Lawsuit News: Additional Info and News

Ocella Lawsuit: New factors associated with increased risk for coronary heart disease arouse great interest and enthusiasm, kindling the hope that we may enhance identification of individuals at risk for CHD. Important concerns are that such metabolic factors be biologically plausible, measurable, repeatable, strong, graded, and treatable (37-39). Measurement issues include accuracy and precision for the factor in the laboratory and evidence of low or modest variability in the clinical setting. If the laboratory or biological variability is very large, the utility of the measurement for predictive purposes is seriously reduced. Many years of experience and standardization of measurements are available for some vascular risk factors, and less experience is available for homocysteine. New risk factors may provide clues to pathogenesis and in some instances may improve our ability to predict disease. The ability to predict new vascular disease events should be demonstrated after consideration of the core set of factors that are currently available, including age, sex, blood pressure, cholesterol or LDL cholesterol, HDL cholesterol, smoking, and diabetes mellitus. This criterion is often not met in new investigations and considerable experience and relatively large data sets and follow-up may be necessary to assure that new factors, such as homocysteine, prove useful in predicting vascular disease risk.

Elevated homocysteine levels may be accompanied by decreased blood levels and intake of folate, vitamin B₆, or vitamin B₁₂. These vitamins are important cofactors in the metabolism of homocysteine, and borderline deficiencies are relatively common, affecting approximately 30% of the elderly participants in the Framingham Heart Study. Greater intake of these vitamins in the diet, with supplements in the form of multivitamins, or through fortification of foods, has led to less vitamin deficiency and a decrease in the prevalence of elevated homocysteine levels. Fortification of the food supply in the United States with folate was announced in early 1996 with a mandated enactment date of January 1, 1998. Analyses of homocysteine and folate levels before and after fortification have been undertaken in Framingham Heart Study participants and showed a dramatic decline in the prevalence of low folate levels, a reduction in the prevalence of elevated homocysteine from approximately 20 to 10%, and a modest decrease in mean homocysteine levels from approximately 10 to 9 |J.mol/L.

Lupus anticoagulants or nonspecific inhibitors interfere with the assembly of procoagulant complexes. In vitro, these antibodies are associated with the prolongation of phospholipid-dependent blood-clotting times. Characteristically, clotting times return to normal with the addition of exogenous phospholipid. Lupus anticoagulants may demonstrate specificity for blood-clotting proteins, in particular prothrombin. However, the mechanism by which they promote thrombosis is unknown. Lupus anticoagulants are likely associated with a high risk of first and recurrent thrombosis as well as recurrent pregnancy loss.

LAC are a heterogeneous group of autoantibodies, which prolong the clotting time in a variety of assays and may demonstrate specificity for beta- 2 glycoprotein-1. LAC do not prolong clotting times in assays in which phospholipid is present in excess. This suggests that LAC inhibit in vitro coagulation by interfering with the assembly of procoagulant complexes on phospholipid surfaces. This observation also forms the basis for the test for LAC—a prolonged clotting time, in a phospholipid-limited assay system, that normalizes with the addition of excess phospholipid confirms the presence of LAC. Anecdotal experience suggests that lupus anticoagulants are much less common than anticardio- lipin antibodies, that they are infrequently transient, and that they are associated with a high risk of complications, although none of these observations has been adequately studied. Furthermore, laboratory assays for lupus anticoagulants.