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Blogs Comment On 'Common Ground' Bill, Abortion Coverage In Health Reform Legislation, Other Topics
The following summarizes selected women"s health-related blog entries.~ "Democratic Bill Could Be a Preview of Obama"s Abortion Plan," Dan Gilgoff, U.S. News & World Report"s "God and Country": A recently introduced bill aimed at reducing the need for abortion is "big news because moderate to liberal faith-based advocates are urging the White House to adopt the bill ... as the core of its forthcoming "common ground" plan on abortion and reproductive health," Gilgoff writes. Some conservative religious groups, including the Southern Baptist Convention and the U.S. Conference of Catholic Bishops, "have warned the White House" that the bill is a "deal breaker" for them because of its support for comprehensive sex education and contraception, he writes. The White House "has refused to say which way it"s leaning," Gilgoff writes, adding the Obama administration could "buck" the groups that support the bill and "get behind" the Pregnant Women Support Act, "which is generally considered more robust on reducing demand for abortions and which leaves out contraceptive funding." However, he concludes, "that would be a pretty big surprise" (Gilgoff, "God and Country," U.S. News & World Report, 7/23).~ "New Report: Abortion Providers = American Human Rights Defenders, Now Under Increasing Attack," Jodi Jacobson, RH Reality Check: A new Center for Reproductive Rights report "calls on both the federal and state governments to address the growing threats against and stigmatization and abuse of abortion providers throughout the United States," Jacobson writes. The report "focuses on a key obstacle to the realization of women"s reproductive rights ... and recognizes their work as human rights defenders," she writes, adding that the U.S. has "historically been a leader both in creating and in encouraging accountability to human rights principles throughout the world." However, "[a]ccess to reproductive health care generally and abortion care specifically are basic human rights largely ignored within the context of U.S. domestic politics," Jacobson writes, noting that abortion access in the U.S. "has been increasingly limited due to the range of obstacles created through anti-choice advocacy." The report highlights several "types of rights violations [that] are most pervasive in limiting women"s choices and the rights of abortion providers," including "intimidation and harassment," "stigma" and "legal restrictions." The report makes a "series of recommendations for change at the state and local level for changes in policy and in law enforcement practices, as well as for the federal government, medical community and non-governmental organizations," Jacobson concludes, adding that the report "makes a special plea for the United Nations Special Rapporteur to document violations of women"s human rights in the United States" (Jacobson, RH Reality Check, 7/22).~ "Sixteen Governors Call on Congress To Include Medicaid Family Planning State Option in Health Reform," Jodi Jacobson, RH Reality Check: "Sixteen governors have written a letter to both Senate and House Leadership "expressing strong support for the Medicaid Family Planning State Option,"" which is included in President Obama"s fiscal year 2010 budget proposal, Jacobson writes. The governors wrote, "Many of our states have created family planning expansion programs, though we have done so with great difficulty," adding, "Since the early 1990s, 27 states have been granted federal waivers to expand their Medicaid family planning coverage. These demonstration projects have been unqualified successes, providing care to millions of women while saving states [millions] of dollars." Jacobson continues, "The current Medicaid waiver process, however, "puts unnecessary roadblocks in the way of our efforts to maintain and expand coverage for family planning services,"" according to the governors. She adds, "Passing this law as part of health care reform "would give us the needed flexibility to quickly and efficiently expand cove
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Mental Health

FDA Grants Approval For Use Of RISPERDAL(R) CONSTA(R) As Both A Monotherapy And Adjunctive Therapy In The Maintenance Treatment Of Bipolar I Disorder

risperidone was significantly higher than with placebo. RISPERDAL(R) CONSTA(R) is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with the use of antipsychotic medications, including RISPERDAL(R) CONSTA(R). Clinical manifestations include muscle rigidity, fever, altered mental status and evidence of autonomic instability (see full Prescribing Information). Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and associated with ketoacidosis, hyperosmolar coma or death has been reported in patients treated with atypical antipsychotics (APS), including RISPERDAL(R) CONSTA(R). Patients starting treatment with APS who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Orthostatic Hypotension: RISPERDAL(R) CONSTA(R) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Monitoring should be considered in patients for whom this may be of concern. RISPERDAL(R) CONSTA(R) should be used with caution in patients with known cardiovascular disease, and conditions that would predispose patients to hypotension. Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first sign of a decline in WBC and in the absence of other causative factors, discontinuation of Risperdal Consta should be considered. Potential for Cognitive and Motor Impairment: RISPERDAL(R) CONSTA(R) has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that RISPERDAL(R) CONSTA(R) does not affect them adversely. Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia. Priapism has been reported. Severe priapism may require surgical intervention. Thrombotic Thrombocytopenic Purpura (TTP) has been reported. Administration: Care should be taken to avoid inadvertent injection into a blood vessel. Suicide: The possibility of suicide attempt is inherent in psychotic illnesses. Close supervision of high-risk patients should accompany drug therapy. Increased sensitivity in patients with Parkinson"s disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS. Use Risperdal Consta with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses. (e.g. Recent Myocardial infarction or unstable cardiac disease) Extrapyramidal Symptoms (EPS): The overall incidence of EPS-related adverse events in patients treated with 25 mg and 50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%). Weight Gain: In a 12-week trial, the percentage of patients experiencing weight gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R). Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment. Commonly Observed Adverse Reactions for RISPERDAL(R) CONSTA(R): The most common adverse reactions in clinical trials in patients with schizophrenia (greater than or equal to 5%) were headache, Parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremities, and dry mouth. The most common adverse reactions in clinical trials in patients with bipolar disorder trials were weight increased (5% in monotherapy trial) and tremor and parkinsonism (greater than or equal to 10% in adjunctive therapy trial). (This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Janssen and/or Johnson & Johnson"s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson"s Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Janssen Pharmaceuticals

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