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Pharmaceutical Liability

FDA warns that antipsychotic may cause compulsive sex, eating

A drug commonly used to treat mental illness has a frightening side effect, the Food and Drug Administration announced recently. The agency says the drug, Abilify ( aka aripiprazole ) can cause compulsive behavior, including overeating, gambling and an uncontrollable desire for sex, TIME reports. Abilify is an antipsychotic used as a mood stabilizer and reduces hallucinations. Doctors prescribe it to treat schizophrenia, bipolar disorder, Tourrette’s syndrome and autism. The FDA was already aware that aripiprazole can cause compulsive gambling, in a new statement the agency warned that it appears to cause other extreme behaviors in some people. Specifically, some…

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Feds Concerned By Compounding Pharmacy Quality Controls

Officials from the U.S. Food and Drug Administration are concerned by the quality controls at several compounding pharmacies. The drug injury lawyers at Walkup Melodia law firm have handled a number of cases over the last ten years where injury occurred as a result of adulterated or misbranded drugs produced at so-called “compounding pharmacies”. The FDA recently announced large scale recalls of non- sterile compounded consumer products due to the failure of an independent third party laboratory to properly conduct sterility tests. The most recent compounding pharmacy to recall its product is Medaus Pharmacy. The FDA says that the procedures…

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Sleeping aids may create unsafe morning drivers, officials say

On an early July morning, the wife of New York governor Andrew M. Cuomo was driving on Interstate 684 when she crashed her car into a tractor-trailer. After swerving into the truck, Mrs. Kennedy kept driving and exited the highway. The New York Times reports that New Castle police officer Joel Thomas found Mrs. Kennedy dazed in her damaged Lexus. Officer Thomas said that Mrs. Kennedy had impaired speech. She complained of being dizzy and had no memory of the crash. Speculation immediately began that the governor’s wife was intoxicated behind the wheel. Mrs. Kennedy told authorities that she occasionally…

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FDA Issues Compounding Pharmacy Warning

Officials from the U.S. Food and Drug Administration recently issued a warning to healthcare providers concerning drugs made by NuVision Pharmacy. The FDA questions the sterility of products manufactured by this compounding pharmacy. Sterile drugs which contain microbes can seriously sicken or kill patients. This most recent FDA announcement comes amid a renewed focus on sterility issues at compounding pharmacies. Last year at least 50 people were killed and another 700 were injured because of a fungal meningitis outbreak linked to drugs from a Massachusetts-based compounding pharmacy. Officials found unsanitary conditions at the facility were the defective drugs were manufactured….

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Amgen to pay $762M for marketing deadly drug to cancer patients

Drugmaker Amgen recently agreed to a $762 million settlement of criminal penalties and whistleblower lawsuits related to its illegal marketing of Aranesp, an anemia drug. Federal prosecutors say that the drugmaker marketed its pharmaceuticals for uses that the U.S. Food and Drug Administration (FDA) explicitly ruled out. “Promoting drugs for unapproved purposes is beyond wrong; it jeopardizes the health and safety of the public,” said FBI Assistant Director in Charge George Venizelos. The bulk of Amgen’s off-label marketing was through the promotions of its anemia drug Aranesp to cancer patients who were not undergoing chemotherapy. The FDA explicitly ruled out…

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Report: Counterfeit medicines a growing problem in the U.S.

The cost of pharmaceuticals is a growing problem in the United States and many doctors and patients seek to cut costs by buying online. One internet pharmaceutical company called CanadaDrugs has grown exponentially in the past few years by allowing American physicians and consumers to buy drugs from price-controlled countries such as the U.K. and Turkey. Although lots of physicians are willing to ignore the fact that prescribing many of these imported discount drugs is illegal, an arguably bigger problem is that many of these drugs turn out to be fake. The Wall Street Journal reports that counterfeit pharmaceuticals are…

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Experts debate the safety of newer oral contraceptives

Medical experts in the U.S. and around the world are beginning to review the safety of newer forms of oral contraceptive pills. The safety of these potentially dangerous pharmaceuticals has been debated due to the risk of blood clots and strokes they pose. Some studies have shown that newer, third- and fourth-generation birth control pills actually double the risk of a woman experiencing a blood clot. The risk of stroke appears to be the same. French health regulators recently decided to stop allowing its state-backed insurers to reimburse the prescription costs of third-generation birth control pills. That country’s health ministry…

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FDA says Pradaxa is unsafe for patients with mechanical heart valves

Drugmaker Boehringer Ingelheim has started to inform physicians that its drug Pradaxa (dabigatran) is not safe for patients with mechanical heart valves. The German pharmaceutical giant says that its oral anticoagulant should not be given to patients with mechanical heart valves because it increases their risk of strokes. The U.S. Food and Drug Administration (FDA) recently issued a “Dear Doctor” letter and a drug safety podcast informing doctors that Pradaxa was a dangerous pharmaceutical for patients with mechanical heart valves and that one European study actually ended early due to the severity of this risk. “The RE-ALIGN clinical trial in…

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Worldwide test proves that ALS drug is ineffective

Drugmaker Biogen Idec recently announced that one of its new pharmaceuticals has proven to be ineffective on patients who suffer from amyotrophic lateral sclerosis (ALS). The drugmaker’s Phase 3 EMPOWER trial found that the drug dexpramipexole failed to show efficacy in function and patient survival. This means that the pharmaceutical is defective and that the drugmaker will have to pursue other solutions for ALS treatment. “We share the disappointment of members of the ALS community, who had hoped that dexpramipexole would offer a meaningful new treatment option,” said Douglas E. Williams, Ph.D., executive vice president of research and development at…

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Investigation continues into deadly fungal meningitis outbreak

A nationwide investigation continues into a fungal meningitis outbreak that has sickened at least 424 people and killed 31 in 19 states, including California. The outbreak is linked to contaminated steroid injections from Massachusetts-based New England Compounding Center. The specialty pharmacy has been on the radar of health and safety inspectors for years but always managed to avoid public reprimand for its unsanitary facilities. The methylprenisolone acetate shots from NECC are not the only dangerous pharmaceutical to be impacted by the specialty pharmacy’s lax cleanliness standards. The Food and Drug Administration recently announced that it found bacteria in several other…

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