Drug Headlines of 2011

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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Drug Approvals Up for 2011

in FDA, General Drug News & Safety

Posted January 9, 2012 by The Scientist The FDA approved 30 drugs last year, the highest number in the last 7 years. The US Food and Drug Administration approved 30 drugs in 2011, compared with 21 in 2010, according to an analysis by Bloomberg News. That number is the highest since 36 drugs were approved in 2004. Some of the headline drugs to get the green light include Yervoy, a drug that primes the immune system to attack melanoma; Xarelto, which reduces clotting for patients with irregular heartbeats; and Benlysta, the first lupus drug approved in 50 years. The FDA toughened its data requirements in 2007, after critics faulted its response to claims of heart

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Faulty implants, dodgy drugs and a toothless watchdog that’s failing patients

in General Drug News & Safety

Posted January 10, 2012 by MailOnline Just over two years ago consultant plastic surgeon Azhar Aslam became deeply worried — he’d had to remove eight silicone breast implants from women within a few months of each other because they had ruptured prematurely. It struck him as highly unusual. ‘If implants do rupture, it is normally after seven to ten years, and it is usually caused by an impact, such as the wearer falling over or having a car accident,’ he says. But these implants had failed after only two to three years, and the patients had not been involved in any impact.’ All the implants were made by the French firm Poly Implant Prothese (PIP).

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

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

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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Lights Out for Bayer’s YAZ?

in FDA, Yaz

Posted January 6, 2012 by InjuryBoard Bayer AG, Germany’s largest drugmaker, blinked and swallowed hard, at the end of December, when it begged the Court overseeing the YAZ litigation. ayer managed to avoid the first trial which was set to start January 9th, over claims its birth-control pills caused blood clots after Judge Hearndon appointed a mediator in hopes of settling the cases. The plaintiffs were opposed to the setting of a mediator and wanted their day in court. Mediation Ordered U.S. District Judge David Herndon in Illinois postponed the January 9th trial of a lawsuit which alleged that Bayer mislead women about the health risks of its Yasmin family of birth-control pills. The case

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FDA Announces 10 Drugs With Severe Birth Defect Warnings

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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Parents sue Pfizer over birth defects allegedly caused by Zoloft

in Birth Defects, Zoloft

Posted January 5, 2010 by Madison Record A group of parents who claim their children suffered severe birth defects because of Zoloft has filed a lawsuit against the drug’s manufacturer. Mary and David Saville, Terry and Todd Cochran, Anita Kinslow, Wendell Houchens, Erica Woodley and Antwynette Golliday joined a lawsuit filed Dec. 2 in St. Clair County Circuit Court against Pfizer Inc. Pfizer is the manufacturer of Zoloft, the antidepressant medication at the center of the suit. According to the nine-count complaint, the female plaintiffs were all prescribed Zoloft during their pregnancies, despite the alleged risks posed to their unborn children. The mothers claim their babies were all born with major medical defects, including heart

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Judge Rules Against GSK in Paxil Mass Tort

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

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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