FDA & Prescription Drugs | InjuryBoard Orange County

A comprehensive new study is underway by two U.S. Department of Health and Human Services agencies, to determine if prescription medications used to treat attention deficit hyperactivity disorder (ADHD) increases the risk of heart attack, cardiovascular problems or stroke.Research supported by the U.S. Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ)...

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According to a new study, reports of adverse drug affects reported to the Food and Drug Administration has doubled over the past decade. Deaths associated with serious adverse drug effects also doubled."A change of this magnitude ought to be cause for alarm," says Thomas J. Moore, senior scientist, drug safety and policy, for the Institute for Safe Medication Practices in Huntingdon Valley, Pa.,...

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GlaxoSmithKline's (GSK) type2 diabetes drug Avandia, is once again the center of controversy after new research claims that using the drug increases the risk of heart attack. A research paper published in the Journal of the American Medical Association (JAMA) discovered that patient's who take Avandia, were 42 percent more likely to suffer a heart attack then those that were in the control...

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Manufacturers of certain drugs approved for treating Type 2 diabetes have agreed to add stronger warnings on the risk of heart failure, announced the U.S. Food and Drug Administration (FDA). The information will be included in a "boxed" warning - the FDA's strongest warning. The updated warning label will highlight that certain drugs may cause or worsen heart failure in some patients.The FDA...

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Safety data from controlled clinical trials has shown a significant increase in the risk of heart attack and heart-related deaths in patients that are taking Avandia (rosiglitazone) for type 2 diabetes.However, there is other published and non published data from long term clinical trials that contradict the evidence about the risk of heart attack in patients currently taking Avandia.While the...

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The U.S. Food and Drug Administration last week turned down pharmaceutical giant, Merck & Co.'s request to market Arcoxia, a successor to its banned arthritis drug Vioxx, according to an article posted on HealthDay's Web site. The decision came as little surprise, since an FDA advisory panel of medical experts had already voted 20-1 on April 12 against the approval of Arcoxia, a drug very...

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The FDA has requested that the makers of antidepressant drugs expand their warning labels to include adults age 18-24. The labels currently have similar warnings for adolescents and children.The maker of Prozac - Eli Lily Co and Pfizer Inc - Zoloft manufacturer and many other drug companies, said they will comply with the FDA's request."We believe this step will help ensure that the millions of...

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The FDA in cooperation with the manufacturers that distribute Permax (pergolide), have agreed to withdraw the drug from the market due to potential heart valve damage. Two new studies showed that patients with Parkinson's disease that were treated using Permax (Pergolide) had an increased chance of serious damage to their heart valve. Permax is a member of a class of drugs that are known as...

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Jen-On Herbal Science International Inc. is voluntarily recalling one of their supplements sold under the name HS Joy of Love. The recall was announced after they were informed by the Food and Drug Administration (FDA) that lab analysis completed by the FDA, found the product contained Piperadion Vardenafil, an analog of Vardenafil, an FDA approved drug that is used for the treatment of male...

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A class action lawsuit against Merck, filed by investors', has been dismissed by a U.S. federal judge regarding their drug Vioxx, an anti-inflammatory medication.The lawsuit was filed over specific disclosures regarding Vioxx which Merck took off the market in September 2004. Clinical studies showed patients that were taking the drug for 18 months or longer were at a higher risk of suffering a...

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A furor over the a new Merck painkiller that is "just like Vioxx" has spurred the U.S. Food and Drug Administration, according to an article in The Boston Globe.The article says that some analysts are scratching their heads at Merck & Co.'s plan to sell a new painkiller that is not much different than Vioxx, the blockbuster drug it pulled from the market in 2004 after several said that it...

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A jury in the Midwest this week cleared drugmaker Merck of liability in a case involving its once-blockbuster painkiller Vioxx saying that a 52-year-old obese woman didn't die because she took Vioxx, but from several other health complications.A Madison County court jury found that Merck & Co. adequately warned doctors and consumers about possible complications from using Vioxx. After...

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Should we trust Merck after Vioxx?Is mandating innoculations the way to go? The National Vaccine Information Center has asked state officials to investigate the safety of a Merck-produced "breakthrough cancer vaccine," which is said to prevent the sexually transmitted virus that causes cervical cancer, the Washington Times reported.According to the Feb. 3 article, negative side effects are being...

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Osteonecrosis allege by Fosamax Users Merck & Co., the drug maker who was already battered by numerous Vioxx lawsuits, is preparing for an avalanche of litigation from patients claiming they were harmed by Fosamax, the company's quick-selling osteoporosis drug, according to an article on consumer.com.Merck reportedly announced last week that it is setting aside $48 million to set up a defense...

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The Food and Drug Administration is now proposing steps to improve the safety of prescription medication after years of criticism of its drug safety standards and the much-publicized Vioxx scandal.The new steps are designed to make sure concerns about potential drug safety are widely circulated within the agency before a drug is given the stamp of approval, according to an article in...

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