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Drug Headlines of 2011

Published on January 21, 2012 by Scott G. in *Featured, FDA, General Drug News & Safety

Posted December 20, 2011 by The Scientist A list of this year’s newsworthy successes—and failures—in drug development Developing new medicines is tricky business, requiring sound science, regulatory savvy, and marketing skills. The past year has seen success and failure in all these realms. Here, The Scientist recounts some of the noteworthy drug developments of 2011. Notable Drug Approvals: First new lupus drug in 52 years After more than 18 years of development, the US Food and Drug Administration (FDA) approved the first drug to treat lupus in more than a half-century. Benlysta (belimumab) is a human monoclonal antibody, produced by Human Genome Sciences and GlaxoSmithKline, that cuts B-cells proliferation, a proposed mechanism underlying the autoimmune

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J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says

Published on January 20, 2012 by Scott G. in *Featured, FDA, Kugel & Transvaginal Mesh

Posted January 5, 2012 by Bloomberg Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women. The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness, the agency’s William Maisel said yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products. Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the

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Coming Out from the Shadow of Paxil Birth Defects

Published on January 19, 2012 by Scott G. in *Featured, Antidepressant, Birth Defects, GSK, Paxil, SSRI

Posted December 13, 2011 by Gordon Gibb Washington, DC: Anyone sitting on the fence over whether or not to go after GlaxoSmithKline (Glaxo) over Paxil side effects need only contemplate the reported $3 billion that Glaxo has agreed in principal to pay, in order to settle charges of off-label marketing and fraud. Combine that figure with the reported $1 billion Glaxo is believed to have paid out last year to settle many a Paxil lawsuit, and suddenly we are talking about amounts of money so vast, it’s beyond comprehension for most. Four billion dollars would buy more than 1,300 very nice cars, at about $30,000 each. People with vehicles about to fall apart would be

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FDA Announces 10 Drugs With Severe Birth Defect Warnings

Published on January 19, 2012 by Scott G. in *Featured, Antidepressant, Birth Defects, Darvocet, FDA, Heart Risk, Paxil, Prozac, SSRI, Zoloft

Posted January 10, 2012 by SB Wire San Diego, CA — (SBWIRE) — 01/10/2012 – The drugs found on this list went through multiple tests, research experiments, and survey before the FDA classified them as dangerous to babies during pregnancy. Zoloft (sertraline), a popular antidepressant known as a “selective serotonin reuptake inhibitor” (SSRI), is linked to dangerous side effects in users and serious birth defects (including, heart murmur, hole in the heart and other serious heart defects) if taken by pregnant women. Since 2006, the FDA has warned against the use of Zoloft and other SSRIs in pregnant mothers. Paxil (paroxetine), one of the most widely prescribed SSRI’s for depression in adults has also been

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Judge Rules Against GSK in Paxil Mass Tort

Published on December 23, 2011 by Scott G. in *Featured, Antidepressant, GSK, Paxil

Posted December 19, 2011 by Legal Newsline PHILADELPHIA (Legal Newsline) – U.S. District Judge Timothy Savage has once again rejected an attempt by GlaxoSmithKline to remove Paxil mass tort litigation case from the Philadelphia state courts to federal court in Philadelphia. GSK tried to maintain that although the company is headquartered in Philadelphia, its “nerve center” was in Delaware and therefore the cases should be in federal courts. The cases in question were originally filed in state court in Philadelphia, but GSK removed them to federal court in Philadelphia citing that the parties are citizens of different states. GSK claimed citizenship in Delaware where its holding company is domiciled. The judge ruled that because GSK’s

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Antidepressants Used By 11 Percent of Americans

Published on December 23, 2011 by Scott G. in *Featured, Antidepressant, FDA, Paxil, Prozac, SSRI, Zoloft

Posted December 22, 2011 by Seattle Times The woman leaning against a pillar didn’t know more Americans — twice as many — take antidepressants than go to movie theaters weekly. She hadn’t heard that a federal study found the meds are used by 23 percent of middle-aged women — almost one in four. But she knows Prozac. “Good stuff,” she said, remembering how it helped her deal with a splintering marriage. Data released by the U.S. Centers for Disease Control and Prevention in November showed that 11 percent of Americans ages 12 and older used Prozac, Zoloft, Paxil or other antidepressants. Women were prescribed the pills more than men, according to national surveys that asked

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Zoloft Side Effects – Birth Defects in Detail

Published on September 28, 2011 by Scott G. in *Featured, Birth Defects, Carey & Danis, Zoloft

Posted September 26, 2011 by Carey & Danis Side effects from Zoloft, a brand name antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs), may cause life-altering and potentially life-threatening side effects / birth defects for newborns of women who took the drug during pregnancy. If your child has been harmed, contact Carey Danis & Lowe immediately. We represent hundreds of families that have been affected by Zoloft Birth Defects. If you are looking for a compassionate law firm that is experienced with defective drugs and the adverse effects of Zoloft, contact us. Our PPHN lawyers are investigating the dangers of this drug and the possible link to the birth defect PPHN

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Zoloft Birth Defects: Craniosynostosis

Published on September 28, 2011 by Scott G. in *Featured, Birth Defects, Zoloft

Posted September 26, 2011 by Carey & Danis Craniosynostosis In craniosynostosis one or more of the joints in the skull, known as sutures, fuse prematurely. This can result in the brain pushing the skull out in other directions, causing a misshapen head and possible facial deformities. Craniosynostosis Symptoms and Diagnosis The symptoms of craniosynostosis are usually detected soon after the birth during routine examinations of the baby. The newborn may be missing the “soft spot,” or the soft spot may disappear soon after birth. In some cases there may be raised ridges along the fused sutures, or there may be no increase in the size of the baby’s head as it gets older. Neurological exams,

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Avandia Statute of Limitations Motion to Dismiss Denied by MDL Judge

Published on September 28, 2011 by Scott G. in *Featured, Avandia, GSK

Posted September 20, 2011 by AboutLawsuits A federal judge has rejected an attempt by GlaxoSmithKline to throw out dozens of Avandia lawsuits, which the drug maker attempted to argue were filed after the statute of limitations expired. U.S. District Judge Cynthia M. Rufe, who is presiding over the federal Avandia litigation, denied a motion to dismiss 60 lawsuits filed by former Avandia users who claim the diabetes drug caused them to suffer heart problems. GlaxoSmithKline argued that the Avandia statute of limitations, which dictates the amount of time an injured party has to file their Avandia lawsuit, should have started as early as May 2007, when a study was released that linked Avandia to an

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Important Information for Paxil Lawsuits and Paxil Recall Victims

Published on September 28, 2011 by Scott G. in *Featured, Birth Defects, GSK, SSRI

Posted September 20, 2011 by AllVoices A prescription drug commonly used for the treatment of depression, obsessive-compulsive disorder, panic disorder, and anxiety disorders, paroxetine is sold under the brand Paxil. The drug is manufactured and distributed by British pharmaceutical heavyweight GlaxoSmithKline. British pharmaceutical company SmithKline Beecham merged with other companies into GlaxoSmithKline. They developed paroxetine and acquired approval from the U.S. Food and Drug Administration (FDA) as Paxil in 1992. The drug comes in two versions: an oral tablet with 10mg to 50mg of paroxetine, and in an oral suspension formulated with 10mg paroxetine per 5mL. As per 2006 records, doctors have filled out 19.7 million Paxil prescriptions. Paxil is a very powerful concoction under

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Archive for the ‘*Featured’ Category:

Drug Headlines of 2011

J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says

Coming Out from the Shadow of Paxil Birth Defects

FDA Announces 10 Drugs With Severe Birth Defect Warnings

Judge Rules Against GSK in Paxil Mass Tort

Antidepressants Used By 11 Percent of Americans

Zoloft Side Effects – Birth Defects in Detail

Zoloft Birth Defects: Craniosynostosis

Avandia Statute of Limitations Motion to Dismiss Denied by MDL Judge

Important Information for Paxil Lawsuits and Paxil Recall Victims

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