Archive for the ‘General Drug News & Safety’ Category:


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Drug Headlines of 2011

Published on January 21, 2012 by 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

Published on January 20, 2012 by 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

Published on January 20, 2012 by 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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Group Says Actos Bladder Cancer Risk More Reason for “Do Not Use” Warning

Published on November 4, 2011 by in Actos, General Drug News & Safety

Posted November 4, 2011 by AboutLawsuits Public Citizen, a prominent consumer watchdog group, has indicate that the risk of bladder cancer from Actos is further proof that the diabetes drug needs to be removed from the market, and reinforces their earlier decision to place the drug on their “Do Not Use” list. The group has listed Actos, a Takeda Pharmaceuticals diabetes drug, as a drug that consumers should avoid for some time, as Public Citizen believes that the risk of Actos side effects outweigh potential health benefits. In addition, the group has suggested that several safer drugs are available, such as metformin and glipizide. Actos (pioglitazone) is a member of a family of drugs called

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Parents Claim Zoloft Caused Newborn’s Fatal Neural Tube Defect

Published on October 7, 2011 by in Birth Defects, General Drug News & Safety, Paxil, Prozac, SSRI, Zoloft

Posted October 5, 2011 by Beasley Allen A Cleveland, Ohio, couple is suing the makers of the antidepressant Zoloft, alleging use of the drug during pregnancy caused their newborn baby to die shortly after birth from a serious birth defect of the brain and spinal cord. Susan and James Hodge filed the Zoloft lawsuit against Pfizer and Cardinal Health in Cuyahoga Court of Common Pleas, alleging the drug companies knew the antidepressant could cause fatal neural tube birth defects but covered up studies that documented the dangers. The Hodges baby was born with a defect known as anencephaly, in which a large part of the brain and skull are missing. The condition is almost always

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The Link Between Antidepressants and Autism

Published on October 7, 2011 by in Birth Defects, General Drug News & Safety, Paxil, Prozac, SSRI, Zoloft

Posted October 7, 2011 by Hive Health From 1994 to 2005, the number of children in the United States taking part in special education programs for autism increased from 22,664 to 193,637. From 1996 to 2005, the number of Americans taking antidepressants nearly doubled to the point where ten percent of the population had a prescription for at least one antidepressant. It’s difficult not to see a relationship between these two statistics. In fact, a new study shows a direct correlation between pregnant women who take antidepressants—specifically, selective serotonin reuptake inhibitors (SSRIs) like Zoloft and Paxil—and then give birth to children with Autism Spectrum Disorder (ASD). Kaiser Permanente performed a study published in July, 2011,

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Widely Used SSRIs Raise Concerns of Birth Defects

Published on August 18, 2011 by in Birth Defects, General Drug News & Safety, Paxil, Prozac, SSRI, Zoloft

Posted August 8, 2011 by Jennifer Walker-Journey According to a recent study, nearly 75 percent of all antidepressants were prescribed to patients without documented psychiatric conditions by non-psychiatrists in 2007, raising a host of concerns including the potential for patients to suffer serious side effects from the drugs that could put their unborn children at risk. The study, which was published in the Health Affairs journal, was co-authored by Mark Olfson, a professor of clinical psychiatry at Columbia University. The results were reported by the Wall Street Journal. Antidepressants were the second-most widely prescribed class of drugs in 2010, second only to cholesterol-lowering statins. Zoloft or a generic version of the drug known as sertraline

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Johnson & Johnson Wins Second Trial Over Levaquin Claims

Published on June 23, 2011 by in Carey & Danis, General Drug News & Safety

Posted June 21, 2011 on SF Chronicles June 17 (Bloomberg) – Johnson & Johnson properly warned of the risks of its antibiotic Levaquin and isn’t responsible for a tendon injury sustained by an 84-year-old man, a Minneapolis jury said. Calvin Christensen, who said he ruptured the Achilles tendon in his right foot after taking the drug while hospitalized with pneumonia, sued the company and its Ortho- McNeil Pharmaceutical unit in 2007. Christensen said the companies downplayed the risks of Levaquin to boost the drug’s sales. Johnson & Johnson denied any failure to warn and contended Christensen needed Levaquin to treat the pneumonia. The Minneapolis federal court jury rejected his claim today. Christensen was seeking unspecified

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Cymbalta vs Paxil

Published on May 18, 2011 by in General Drug News & Safety, Paxil, SSRI

Posted May 7, 2011 on Heal Blog Depression is a condition which needs immediate treatment. Fatal complications like death may occur with depression. As such, many drugs have been manufactured by drug companies and extensive researches are being conducted to arrive at the best medications to treat depression. Cymbalta and Paxil are two common drugs used in treating clinical signs and symptoms of depression. It is important to understand the difference and similarities between both drugs to be safe while taking them: What We Need To Know About Cymbalta and Paxil? Duloxetine (Cymbalta) and Paroxetine (Paxil) are both antidepressants. Though their generic names may sound similar, Cymbalta and Paxil are from two different drug categories.

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Medication Use in Pregnancy Rises

Published on May 2, 2011 by in Birth Defects, General Drug News & Safety, Paxil

Posted April 27, 2011 on MyHealthNewsDaily An increasing number of pregnant women in the United States are on medication, and many of them are taking more than one, a new study finds. Over three decades, the use of prescription medication in the first trimester of pregnancy has increased 60 percent, and the use of four or more drugs by pregnant women has tripled, the researchers say. In 2008, the latest year in the study, half of women reported taking at least one medication while pregnant. But is such a practice safe? More and more has been learned over the years about the effects of drugs on the developing fetus. Some drugs are clearly linked to

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