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Drug Approvals Up for 2011

Published on January 20, 2012 by Scott G. 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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Vaginal Mesh Lawsuits Have Senate Seeking Increased Safety Measures

Published on December 23, 2011 by Scott G. in Kugel & Transvaginal Mesh

Posted December 21, 2011 by OpenPR (openPR) – Los Angeles, CA, December 20, 2011 – Nadrich & Cohen LLP reports that the U.S. Senate has proposed a new piece of legislation aimed at reducing the number of consumers who suffer serious injuries caused by a defective medical device. The bill, which would require manufacturers to conduct ongoing safety studies of these devices after obtaining FDA approval, was drafted in part as a response to the growing number of lawsuits filed against the makers of problematic vaginal mesh implants. Currently, the Food and Drug Administration allows certain medical devices to be approved under its 510(k) system. Based on these guidelines, manufacturers need only to demonstrate that

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Recent Cancer Lawsuits Highlight Alleged Danger of Actos

Published on November 11, 2011 by Scott G. in Actos

Posted October 19, 2011 by Newsome The U.S. Food and Drug Administration recently announced “that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” The FDA explains that from January 2010 through October 2010, “approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.” The FDA also explains that the “patient Medication Guide for these medicines will be revised to include information on the risk of bladder cancer.” However, these safety measures may have come too late. Actos bladder cancer lawsuits have already been filed by dozens of individuals who claim Takeda pharmaceuticals, the maker of the

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FDA Reviewing Yaz Blood-Clots Risk

Published on October 7, 2011 by Scott G. in Yaz

Posted October 4, 2011 by WebWire Lawsuits alleging that a popular birth-control pill Yaz is causing blood clots and a host of other medical problems for women got a boost from the Food and Drug Administration when it recently announced it was going to review the drug.Thousands of women already have filed a Yaz lawsuit against Bayer the manufacturer of Yaz and Teva, the pharmaceutical company that makes Yaz in other forms called Yasmin and Ocella. The lawsuits contend that the pharmaceutical companies did not sufficiently disclose or warn potential users of the birth-control pill of its serious and sometimes fatal side effects.A federal judge has already established a schedule for some of the ground-breaking

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Does Paxil Cause Birth Defects?

Published on August 18, 2011 by Scott G. in *Featured, Birth Defects, FDA, Paxil

Posted August 16, 2011 by Kidgas I was watching TV over at my parent’s house this weekend since we were there to celebrate the family birthdays for the month and noticed one of those lawyer ads about Paxil. It implored anyone who had taken Paxil for depression and had had a baby with birth defects to call this particular number and find out if you had a claim. I was surprised and hadn’t heard anything about Paxil birth defects, so I thought I would look it up on the internet. Paxil is used for the treatment of depression and other psychiatric disorders. It is part of a class of drugs known as selective serotonin reuptake

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Study: American’s Use of Antidepressants On The Rise

Published on August 8, 2011 by Scott G. in *Featured, Paxil, Prozac, SSRI, Zoloft

Posted July 21, 2011 on USA Today Americans are popping more antidepressants than ever before to deal with everyday stress, and non-psychiatrists are increasingly willing to prescribe the drugs to patients with no mental health diagnosis, a new study finds. Antidepressants such as Prozac, Paxil and Lexapro are now the third most widely prescribed group of drugs in the United States, and many people may take them for minor complaints without being fully aware of potential risks, the researchers said. “Both consumers and prescribers of antidepressants should be more knowledgeable about the indications (or symptoms) that antidepressants are better for,” said study lead author Dr. Ramin Mojtabai, an associate professor of psychiatry at the Johns

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If Your Child Is Suffering From Paxil Birth Defects, You Have Legal Rights That Should Be Explored

Published on July 26, 2011 by Scott G. in Birth Defects, GSK, Paxil

Posted July 20, 2011 on paxilblog1msn Paxil is a popular antidepressant medication that has been regularly prescribed to people dealing with behavioral disorders since it was released in 1992. People take Paxil to treat conditions such as anxiety, stress and depression. The drug has proven to be effective for these disorders but studies have revealed that there are risks to Paxil use that were not originally communicated to patients. Specifically, women who are pregnant or plan to get pregnant, are now advised not to take the medication as it could lead to Paxil birth defects. Warnings of potential Paxil birth defects, however, were not given until just the last few years. In 2009, the Food

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Johnson & Johnson Wins Second Trial Over Levaquin Claims

Published on June 23, 2011 by Scott G. 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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Antidiabetic Drug Avandia To Be Pulled From Retail

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

Posted May 24, 2011 on TheAdvertiser USA TODAY The diabetes drug Avandia will be pulled from retail pharmacy shelves in November because it poses such a big heart attack risk, the federal government announced Tuesday. When the new program goes into effect on Nov. 18, only certified doctors will be allowed to prescribe the drug, and only to patients who’ve been informed of the risks and who will fill their prescriptions by mail order through specific pharmacies. “It’s like a decade-long nightmare coming to an end,” said Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic. “Eleven years after this drug was introduced, it will be so restricted in access that virtually no one

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What Causes Many Birth Imperfections Of The Heart, Lungs And Brain? Antidepressant Paxil

Published on March 30, 2011 by Scott G. in *Featured, Birth Defects, Heart Risk, Paxil, SSRI

Posted March 30, 2011 on LawsuitInformation.org One of a family’s worst nightmares is for an innocent child to be born with birth defects threatening their life or well being. And many have been subjected to this nightmare due to a defective drug: the antidepressant Paxil. When a pregnant woman takes Paxil while pregnant, particularly during the first 3 months, her baby is a great deal more sure to suffer one or more of a spread of birth defect injuries as a result. Such birth problems include injuries to the heart, lungs, brain, backbone, limbs, abdominal wall, urinary tract and gastrointestinal system. Such wounds may need surgery or perhaps repeated surgeries to fix, especially heart birth

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Posts Tagged ‘Drug Administration’:

Drug Approvals Up for 2011

Vaginal Mesh Lawsuits Have Senate Seeking Increased Safety Measures

Recent Cancer Lawsuits Highlight Alleged Danger of Actos

FDA Reviewing Yaz Blood-Clots Risk

Does Paxil Cause Birth Defects?

Study: American’s Use of Antidepressants On The Rise

If Your Child Is Suffering From Paxil Birth Defects, You Have Legal Rights That Should Be Explored

Johnson & Johnson Wins Second Trial Over Levaquin Claims

Antidiabetic Drug Avandia To Be Pulled From Retail

What Causes Many Birth Imperfections Of The Heart, Lungs And Brain? Antidepressant Paxil

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