FDA & Prescription Drugs | InjuryBoard Sarasota

After two people died, Novartis AG has pulled its pain relief drug Prexige from the market in Australia. According to a story published in the Wall St. Journal, "Australia's Therapeutic Goods Administration said it had received eight reports of serious liver reactions in patients taking the drug. "It seems that the longer people are on the medicine, the greater the chance of liver injury," its...

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Purdue Pharma L.P., the manufacturer of the popular Oxycontin, has been ordered to pay the stiff penalty of $634.5 million fine for misleading the public regarding the drug's addiction risk. In a Boston Globe article,the drug is "designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected. From 1996 to...

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Eli Lilly, the manufacturer of the drug Zyprexa, may face more legal troubles after the FDA told the company it would delay the approval of its new drug Symbyax for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac. Zyprexa has...

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Amgen was a rising star in the pharmaceutical industry until serious questions arose about the safety of two of its biggest selling drugs which treat anemia in cancer and kidney-failure patients. A black-box warning placed March 9 on the labels of those and other anemia drugs urges doctors to use the smallest possible dose of the drugs. The two anemia drugs, Epogen and Aranesp make up almost...

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Two studies linking the Parkinson's drug Permax with heart valve damage have resulted in Valeant Pharmaceuticals International pulling the once popular drug from the market. The FDA had asked the drug manufacturer to discontinue marketing the product after the heart valve injury studies. If you are taking or have taken Permax for Parkinson's disease, you should consult your physician for...

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The journal Drug Injury Watch reports that "new study published in the March 2007 issue of the medical journal Archives of Neurology provides further support to the theory that the long-term use of Permax (pergolide) for Parkinson's disease increases the risk of valvulopathy, primarily cardiac valve regurgitation. In comparison, the same study found that Mirapex (pramipexole) and Requip...

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The FDA has told manufacturers of certain sleep aids that they must put stronger warnings on their labels in order to advise consumers of the possible side effects. The products include the popular Lunesta and Ambien.

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The FDA has issued a "black box" warning concerning a family of anemia drugs that have high cancer and heart risks associated with them. The news was a particularly harsh blow to Amgen. The biotech giant alone accounted for $5.3 billion in U.S. sales from its best-selling products Aranesp and Epogen in 2006. Johnson & Johnson's Procrit fetched another $2 billion in U.S. sales. Roche Group AG,...

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Pharmaceutical companies that manufacture attention deficit hyperactivity disorder will have to warn consumers of possibly dangerous side effects from the drug including mental disorders, heart problems, even sudden death. The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides

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Ann Marie Cisneros, a former employee of contractor Pharmaceutical Product Development Inc., has testified before the House Energy and Commerce Committee that the drug manufacturer knew of Ketek's problems before regulators discovered fraud. Her testimony centered around a study that demonstrated the drug's dangers prior to its US approval by the FDA in 2004.Some House Committee members lashed...

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There's a widespread myth that FDA approval of a new drug product means that that drug is safe for consumer use. Yet, according to a notice published Friday by the US Food and Drug Administration (FDA), from October 2005 through September 2006, companies had yet to initiate 71 percent of outstanding "post-market" safety evaluations that companies have promised to undertake for currently...

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Eli Lilly, the manufacturer of the drug Zyprexa, has aggressively fought to suppress internal company documents from seeing the light of day. The documents, which were highlighted in a December 2006 NY Times article, showed that Eli Lilly intentionally downplayed and hid Zyprexa's dangerous side effects. However, the Electronic Frontier Foundation is fighting back to allow the general public...

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A recent medical study has found a link between some popular over-the-counter antacids such as Prevacid, Prilosec, and Nexium and hip fractures. The greatest danger was found in those who took the drugs in large quantities for a year or more.

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Zyprexa, an antipsychotic drug used to treat schizophrenia, has been linked to diabetes, diabetic coma, even death. The FDA issued a black box warning a few years ago concerning these dangerous side effects.

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Bristol Myers Squibb, the manufacturer of the blood thinning drug Coumadin, has strengthened its warning label concerning the dangers of potentially fatal bleeding. Coumadin, known generically as Warfarin, had previously cited a "risk of hemorrhage" and wasn't highlighted in a black box.

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