Loryna Lawsuit News (01/24/2012) Pharmaceutical companies could be dealing with claims, such as Loryna Lawsuits, regarding safety issues with their contraceptives. For women who are currently on birth control, it is vital to be aware of the risks involved with using these medications. A Safety Review has been released by the U.S. Food and Drug Administration (FDA) regarding contraceptives containing drospirenone and the possible increased risk of blood clots which could lead to stroke, heart attacks, pulmonary embolism and deep vein thrombosis. This drug is generating a growing number of Loryna Lawsuits by individuals who believe it may be the cause of their injuries. If you call Best Legal Source at 800-611-7080 or complete the evaluation form to the right, we will connect you with a Loryna Lawsuit attorney who will discuss your concerns and inform you of your legal options regarding the filing of a Loryna Lawsuit.

The FDA also recommends that women who have questions and concerns about their oral contraceptives should contact their healthcare providers if they experience any side effects such as persistent leg pain, severe chest pain, or shortness of breath. Then, connect with our qualified Loryna Lawsuit attorneys immediately. Time may be limited for the filing of Loryna Lawsuits.

Loryna Lawsuits, Loryna Lawsuit and Loryna Lawsuit attorneys are general terms used to describe the legal process provided by a Loryna attorney experienced in pharmaceutical litigation along with similar cases. The use of these terms, or any other phrase containing the word Loryna, does not imply any connection or relationship between the manufacturers of Loryna and Best Legal Source.

This website is meant for injured parties who believe their injuries were directly related to using the drug Loryna. It was created to assist these individuals find a Loryna Lawsuit attorney among the attorneys experienced in Loryna Lawsuits we know are willing to take their case. Therefore, if you have experienced a blood clot while taking the medication Loryna, let Best Legal Source put you in touch with a knowledgeable group of Loryna Lawsuit attorneys today.

Loryna Lawsuit: More 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@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.

 

 

Loryna Lawsuit News – 2/1/2012: If you were prescribed drug name 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.

Loryna Lawsuit: 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.

The metabolism for homocysteine has become more clear over time and it is now evident that there is a methionine cycle, a folate cycle, and a transsul­furation pathway. Defects in transsulfuration, especially congenital deficiency of cystathionine beta-synthase, may account for some of the persons with elevated homocysteine concentrations, and other pathways were important for the recycling of homocysteine to methionine. Vitamins in the B group often acted as cofactors for reactions at several of the key branching points in the pathways.

Antiphospholipid antibodies (APLA) are a heterogeneous group of autoantibod­ies associated with both arterial and venous thrombosis, recurrent pregnancy loss, and thrombocytopenia. They can occur either in association with other auto­immune conditions, most frequently systemic lupus erythematosus (SLE), or in isolation, a condition known as the primary antiphospholipid antibody syndrome. In the research laboratory, many antiphospholipid antibodies (with varying epi­tope specificity) can be identified. However, in clinical practice, the antiphospho­lipid antibodies are divided into two large groups, the lupus anticoagulants and the anticardiolipin antibodiesz

APLA are found in about 20% of patients presenting with venous thromboembo­lism, in about 10% of patients presenting with first ischemic stroke, and in approximately 5 to 10% of young people presenting with first myocardial infarction. Their prevalence in the unselected population is unknown; reported rates vary widely with the test system used and the population being studied. About 30% of individuals with systemic lupus erythematosus have an APLA. Low-titer anticardiolipin antibodies are frequently detected in otherwise well individuals; repeat testing reveals a high rate of spontaneous resolution.

Loryna Lawsuit News : Additional Information and Resources

Loryna Lawsuit: A congenital or acquired hypercoagulable state should be suspected in all patients presenting with unusual forms of thrombosis or in whom thrombosis occurs at a young age in the absence of identifiable risk factors. Hypercoagulable states associated with venous thrombosis include activated protein C resistance (with or without factor V Leiden), the prothrombin gene 20210A mutation, and defi­ciencies of protein C, protein S, or antithrombin. Hyperhomocysteinemia can be either congenital or acquired and is associated with both arterial and venous thrombosis, as are the antiphospholipid antibodies. Unexpected arterial thrombo­sis in otherwise well patients can be associated with hyperhomocysteinemia or antiphospholipid antibodies.

All patients with unexplained venous thrombosis, in particular those with thrombosis in unusual sites (such as the cerebral veins or mesenteric veins), should be screened for an antiphospholipid antibody. Both a lupus and an anticar- diolipin antibody should be sought. Testing should be carried out in accordance with the recommendations of the International Society of Thrombosis and He- mostasis, with appropriate confirmatory assays for suspected lupus anticoagu­lants. Patients with arterial thrombosis should also be screened for a hypercoag- ulable state if their thrombosis has occurred at a young age, or in an unusual location in the absence of other risk factors such as valvular heart disease. Testing of cholesterol and triglyceride levels, homocysteine levels, preferably in the fast­ing state, and antiphospholipid antibodies may reveal a treatable cause for their episode of arterial thrombosis.

Many questions remain unanswered in patients with antiphospholipid antibodies. First, many patients, particularly those with systemic lupus erythematosus, are screened for the presence of an antiphospholipid antibody despite their never having had an episode of thrombosis. When detected, the clinical importance of the antibody is unknown. As a result, some such patients (who are suspected to have a high risk of first thrombosis) are treated with warfarin with varying INR target ranges, while others are treated with aspirin or other antiplatelet agents, and many receive no antithrombotic prophylaxis. To address the need for routine antithrombotic prophylaxis in this problematic patient population, a large, ran­domized clinical trial is currently being carried out. Within this study, adults and children, with both an antiphospholipid antibody and systemic lupus erythemato­sus, are allocated to long-term warfarin with a target INR of 2.0, or no therapy. The primary outcome measure of the study is the rate of objectively confirmed arterial and venous thrombosis.

Loryna Lawsuit News: News and Information from related Sources

Loryna Lawsuit:  A second frequently encountered clinical problem is determining the opti­mal intensity of warfarin anticoagulation in patients with an APLA and a history of previous thrombosis. Evidence-based treatment recommendations are not available, and there is a large variation in practice habits for patients with this problem. Two large, multicenter trials are currently under way which will address this issue. In both, patients with a persistently positive APLA and a history of arterial or venous thrombosis are allocated to receive warfarin with a target INR that exceeds 3.0 versus lower intensity anticoagulation. These studies will provide (1) guidance for the optimal intensity of warfarin therapy and (2) reliable esti­mates of the risk of recurrent thrombosis in patients treated with warfarin with a target intensity of less than 3.0.

In an effort to improve the rate of successful pregnancy outcomes, a variety of interventions, including low-dose aspirin (ASA), heparin, prednisone, intrave­nous immunoglobulins, and combinations of these therapies, have been used (43­59). It is plausible that antithrombotic therapy (heparin and aspirin) might reduce the risk of pregnancy loss, if this loss is due to placental vascular thrombosis. Prednisone has anti-inflammatory and immunosuppressive properties, which might reduce the risk of fetal loss either by reducing the production of APLA or by reducing placental vascular changes that promote a prothrombotic state (49,52,58,60). Intravenous immunoglobulin is believed to improve the likelihood of successful pregnancy outcomes in patients with APS by either blocking the activity of autoantibodies (mediated by passively transferred anti-idiotypic anti­bodies) or by immune modulation (up-regulation of suppressor T-cell function) (61); both antibody blockade and immune modulation could theoretically prevent placental thrombosis by reducing the levels of APLA.

In a large tertiary care referral center, as many as 45% of patients presenting with recurrent pregnancy loss will have a positive antiphospholipid antibody as the only detectable cause of pregnancy loss. Recent publications suggest that other congenital or acquired hypercoagulable states may be associated with recur­rent pregnancy loss.Before a prothrombotic state is sought in patients with recurrent pregnancy loss, structural, cytogenetic, and endocrinological abnormalities should be ruled out. If no other cause for the pregnancy loss can be discerned, an antiphospholipid antibody should be sought. It remains controversial whether other causes of a prothrombotic condition should be investigated such as the factor V Leiden muta­tion, the prothrombin gene mutation, or hyperhomocysteinemia.

There are many published reports of strategies used for the prevention of fetal loss in patients with APS. However, only a few present data derived from well- designed and executed clinical trials. To provide the most rigorous possible con­clusions, we have limited this review to treatment recommendations derived from studies in which all patients had a persistently positive antiphospholipid antibody and two or more first-trimester pregnancy losses or one or more second- or third- trimester losses. We excluded studies including patients with secondary APLA, such as those with SLE, to eliminate confounding effects of the underlying dis­ease on the likelihood of successful pregnancy outcome, and we excluded nonran­domized studies with less than 10 patients because of the potential for bias in these small case series.

ASA in combination with prednisone , or with heparin. Only two of the six randomized controlled trials or quasirandomized controlled trials had equivalent treatment arms (aspirin alone compared with aspi­rin and heparin). Combining the results of these studies using the Mantel-Haens- zel weighted odds ratio for two categorical independent variables revealed an odds ratio of 3.86 (95% CI, 1.78-8.47), and the weighted relative risk of 1.73 (95% CI, 1.28-2.35), in favor of treatment with heparin and aspirin, compared with aspirin alone. These results suggest that treatment with heparin in addition to ASA is 1.7 times as likely to result in a live birth than treatment with ASA alone.

Loryna Lawsuit News: Information and News

Loryna Lawsuit: Low-molecular-weight heparins are an attractive alternative to standard heparin for many indications because, in animal models, they produce less osteo­porosis than standard heparin, yet they appear to be at least as effective as standard heparin. This suggests that low-molecular-weight heparins would be an excellent choice for anticoagulation during pregnancy. However, until good-quality evidence exists for the effectiveness of the low-molecular- weight heparins in patients with an antiphospholipid antibody and recurrent preg­nancy loss, their routine use cannot be recommended.

In summary, based on currently available literature, it appears that the treat­ment of choice for the prevention of pregnancy loss in women with APS is low- dose heparin and aspirin. Although we cannot confidently exclude the possibility that prednisone plus ASA therapy is as, or more, effective than heparin plus aspirin therapy, prednisone-containing regimens are associated with a higher risk of maternal and obstetric toxicity. In addition, based on our analysis, we conclude that rigorous clinical trials designed to determine the optimal type and duration of treatment to enhance the likelihood of live birth are urgently needed.

As with all other areas in this field, there remain many unanswered questions. Although one small study suggests that low-dose unfractionated heparin increases the likelihood of successful pregnancy outcome, there are no independent, ran­domized studies to support this conclusion. Low-molecular-weight heparins have replaced unfractionated heparin in many clinical circumstances; whether low- molecular-weight heparin can replace unfractionated heparin in this patient popu­lation has never been tested in a randomized clinical trial. Aspirin therapy is widely accepted in this patient population, yet its efficacy has never been proven in a methodologically rigorous study. Finally, the role of anticoagulants or immu­nosuppressant therapy has never been tested in women who are unable to con- cieve, or those with pregnancy loss at less than 8 weeks gestation.

Although the cause of thrombocytopenia in these patients is unknown, the similarities between immune thrombocytopenia purpura and antiphospholipid an­tibody-associated thrombocytopenia suggest that immune-mediated platelet de­struction underlies both disorders. Furthermore, the response of patients with anti­phospholipid antibody-associated thrombocytopenia to immunomodulatory therapy supports the hypothesis that the thrombocytopenia is due to immune plate­let destruction. No large prospective studies of therapy for antiphospholipid anti­body-associated thrombocytopenia have been reported. However, based on anec­dotal experience, therapy with corticosteroids, intravenous immunoglobulin, immunosuppressive agents, and, ultimately, splenectomy for patients with severe, refractory thrombocytopenia may be effective.

Loryna Lawsuit News: Additional Info and News

Loryna Lawsuit:  It is becoming increasingly clear that hormone therapy is not related to risk of stroke, and that rates of venous thromboembolism are higher in women who take hormone therapy than those who do not. Importantly, sparse evidence also suggests that there may be short-term higher risks of cardiovascular disease when women initiate hormone use. An increase in breast cancer is also a concern. In promoting healthy aging in women, alternatives to hormone therapy should be considered; estimates suggest that 82% of coronary disease could be eliminated through adherence to basic guidelines involving moderate exercise, a good diet, and abstinence from smoking.

The findings from the observational studies that hormone users are at generally lower risk from coronary disease do not necessarily imply cause and effect. Women and their physicians decide on estrogen therapy. Often the health status of the woman will have an important influence on this decision and on the results of studies that examine these women. Thus, some have argued that hormone use is merely a marker rather than a cause of good health.

Another approach is to examine the risk profile of estrogen users and non­users to determine whether the differences, if any, are sufficient to explain the large decrease in risk among estrogen users. Barrett-Connor observed that, in a cohort of postmenopausal women, those taking estrogens reported more in­tensive health-care behavior, including frequent screening tests such as blood cholesterol measurement and mammograms. An examination of determinants of estrogen therapy in 9704 women participating in a large, multicenter study of osteoporotic fractures found that hormone users tended to be better educated, less obese, and drank alcohol and participated in sports more often than nonusers. Similarly, in a prospective study of randomly selected premenopausal women, observed a better cardiovascular risk factor profile prior to hormone use among the women who subsequently took hormones at menopause than among women who did not.

For hormone users compared to nonusers and, after further adjustment for high blood pressure, history of angina, MI, or stroke, alcohol use, smoking, body mass index, and age at menopause, the relative risk was virtually the same (RR = 0.79; 95% CI, 0.71-0.88), implying an equivalent risk status for users and nonusers. In addition, to further examine this issue, the Nurses’ Health Study conducted an analysis limited to a subgroup of low-risk women (i.e., those with no diagnosis of hypertension, diabetes, or high serum cholesterol who were nonsmokers and had a Quetelet’s Index below 32 kg/m²). Even with such restrictions, the relative risk for coronary disease was almost 40% lower for current hormone users. In summary, to explain the overall benefit of hormone therapy as a result of con­founding by health status, one would have to presume unknown risk factors which are extremely strong predictors of CHD and very closely associated with estrogen use.

Our use of the term or terms Loryna 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.

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