Category Archives: Drug Side Effects

By Robert Weisman, Globe Staff Federal regulators Friday morning said they approved T-DM1, a promising new breast cancer therapy with potentially serious side effects, for sale in the United States. Key components of the drug were developed by Waltham biotechnology company ImmunoGen Inc., but the drug is being marketed by its partner, the Genentech division of Swiss drugmaker Roche AG, under the brand name Kadcyla. Kadcyla was approved for sale to patients with HER2-positive metastatic breast cancer, an aggressive form of the disease, who have received prior treatment with the drug Herceptin along with a chemotherapy. It is the first antibody-drug conjugate for the disease okayed by the Food and Drug Administration. The approval comes two and a half years after the FDA surprised ImmunoGen, Genentech, and the patient community by rebuffing a bid to give T-DM1 fast-track status in a refuse to file letter that declined to accept an application for accelerated review. While many patients have been taking the drugs in clinical trials or through so-called compassionate use programs, others have been unable to obtain it, sparking protest against the FDA. In a statement Friday, the FDA did not address that controversy. But it said Kadcyla is being … Continue reading →

By Robert Weisman, Globe Staff Federal regulators Friday morning said they approved T-DM1, a promising new breast cancer therapy with potentially serious side effects, for sale in the United States. Key components of the drug were developed by Waltham biotechnology company ImmunoGen Inc., but the drug is being marketed by its partner, the Genentech division of Swiss drugmaker Roche AG, under the brand name Kadcyla. Kadcyla was approved for sale to patients with HER2-positive metastatic breast cancer, an aggressive form of the disease, who have received prior treatment with the drug Herceptin along with a chemotherapy. It is the first antibody-drug conjugate for the disease okayed by the Food and Drug Administration. The approval comes two and a half years after the FDA surprised ImmunoGen, Genentech, and the patient community by rebuffing a bid to give T-DM1 fast-track status in a refuse to file letter that declined to accept an application for accelerated review. While many patients have been taking the drugs in clinical trials or through so-called compassionate use programs, others have been unable to obtain it, sparking protest against the FDA. In a statement Friday, the FDA did not address that controversy. But it said Kadcyla is being … Continue reading →

With pharmaceutical companies having to state the negative side effects of taking their products, drug commercials are often deadly comical. They usually go something like this: If you cant sleep, take medication X and you will sleep like a baby. Warning, side effects may include loss of consciousness and bladder, heart and lung malfunctions. Death could occur with frequent use. Interestingly, the acknowledged potential and serious negative side effects of drugs dont seem to adversely impact sales. People, it would seem, like their drugs and are willing to turn a blind eye to any potential negative outcome, until, of course, their lives become threatened by one of the serious side effects, and then they will likely look to sue the drug company. Much like pharmaceutical companies, congressional Republicans over the past four years have been selling debt and deficit remedies with serious side effects for the economy and the American people, and that is why I am rooting for the March 1 sequestration deadline and the automatic spending cuts it triggers to come to pass, because as the old saying goes, who feels it, knows. The sequestration deadline came out of the Budget Control Act of 2011. The act cut … Continue reading →

According to court documents, on February 5th, 2013 an Illinois man filed a lawsuit in Pennsylvania Eastern District Court alleging that Mercks drug Propecia can lead to serious side effects such as sexual dysfunction. In light of this news, AttorneyOne, a recognized authority on law, informs that they are now providing advice, including how to get in contact with legal counsel, to people potentially affected by Propecia side effects. San Diego, CA (PRWEB) February 21, 2013 According to court documents, on February 5th, 2013 an Illinois man filed a lawsuit in Pennsylvania Eastern District Court (case no. 2:2013cv00659) alleging that Propecia can lead to serious side effects such as sexual dysfunction. Propecia is a pill, manufactured by Merck, for use in males only and indicated for the treatment of male pattern hair loss. It was approved by the FDA in 1997. In the lawsuit plaintiff claims that Merck knew or should have known that Propecia contributes to an increased risk of side effects including depression, cognitive impairment and erectile dysfunction. As Merck & Co reported on November 9th, 2012 approximately 265 lawsuits, involving a total of approximately 415 plaintiffs, have been filed as of September 30th, 2012 alleging persistent sexual … Continue reading →

Vivus Inc. (VVUS)s obesity drug, approved in July in the U.S., failed for a second time to gain the backing of European regulators because of its potential side effects. The European Medicines Agencys Committee for Medicinal Products for Human Use recommended against approving Vivuss pill in October because of concern about the long-term effects on the heart and nervous system. Vivus appealed, and the Mountain View, California-based company said today in a statement that its request was rejected. The agency, called CHMP, said Vivus must conduct a cardiovascular trial to show the drug, which would be called Qsiva in Europe, is safe before it could be approved. We are disappointed with the CHMP decision regarding Qsiva and the position the committee adopted with respect to the need for a pre-approval cardiovascular outcomes trial, Peter Tam, president of Vivus, said in the statement. A majority of CHMP members have failed to recognize the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery. The drug, called Qsymia in the U.S., was the second weight- loss drug to be cleared last year by the Food and Drug Administration. The therapy is a combination of the appetite … Continue reading →

MORE than 1.5 million Australians suffer the side effects of medicines every year, presenting a real danger to public health, physicians say. The Royal Australasian College of Physicians (RACP) wants healthcare professionals to report instances of patients having adverse reactions to drugs to minimise the risk of people taking the wrong medicines. In its federal budget submission, the RACP on Friday called on the Labor government to make the proposed reporting measure mandatory for doctors and healthcare workers. Currently, health carers aren't required to notify the Therapeutic Goods Administration (TGA) about adverse drug reactions. At present only nine per cent of reported cases are provided by this group of professionals. Without reporting, there was a danger that safety issues involving certain medications will go undetected, RACP warns. "Adverse drug events are a significant cost to the Australian community in terms of related visits to general practitioners, hospitals, and in severe cases, death," said Winston Liauw from the RACP's ethics advisory group. At least 400,000 GP visits and 190,000 hospital admissions are linked to the side effects of medicines. The public costs associated with medicine-related hospital visits in 2008 was $660 million, and around half of those visits were preventable, the … Continue reading →

Medications that treat overactive bladder (OAB) have notorious side effects such as dry mouth, constipation, and urinary retention. Womens Excellence in Bladder Control is now trialing and sampling a brand new medication that treats OAB differently. Shelby Township, Michigan (PRWEB) February 20, 2013 Anticholinergic medications used to treat OAB can cause a variety of unpleasant side effects. In most patients, these side effects are mild and tolerable, but in some patients may be severe and intolerable. Common side effects caused by anticholinergic medications include: dizziness, constipation, urinary retention, and dry mouth. These side effects can be severe enough to cause a patient to quit the medication leaving them with no other oral medication option till now. Astellas pharmaceuticals has recently put on the market a new medication to treat OAB, its called Myrbetriq (mirabegron). The agent is as unique as its name and might just become a go to medication for those patients who fail traditional anticholinergic OAB therapy. Myrbetriq is not an anticholinergic drug. It is a beta-3 adrenergic agonist but relaxes the bladder smooth muscle just as anticholinergics do. Myrbetriq can help with symptoms of urge incontinence, urgency, and frequency. It also helps to increase the bladders capacity … Continue reading →

Dallas, TX (PRWEB) February 20, 2013 The birth control resource center at DrugRisk.com is alerting women who have used NuvaRing contraceptive devices of new safety warnings added to the site. Also, complaints to the FDA over the devices continue to rise as trials are set to begin this summer for more than 1,000 cases. DrugRisks mission is to improve patient safety by providing the latest drug warnings, recalls, studies and litigation news. Weve noticed an increase in both injury claims and complaints to the FDA related to NuvaRing following the recent blood clot warnings, explains DrugRisk representative Ryan Mayer. The resource center previously added warnings which link vaginal ring contraceptives such as NuvaRing to higher risks of blood clots than traditional birth control pills. On June 14, 2012, the New England Journal of Medicine published a study finding vaginal ring contraceptives could relate to a 2.5 to 3-fold increased risk of blood clots.* DrugRisk has also discovered that the FDA has received nearly 5,500 adverse event reports of complications among women using NuvaRing devices.** Most common were 1,177 reports of pulmonary embolism and 806 reports of deep vein thrombosis, with hospitalization resulting in over 30% of cases.** The resource center … Continue reading →

New York, NY (PRWEB) February 20, 2013 The birth control resource center at DrugRisk.com is alerting women using the IUD contraceptive Mirena of updated legal news added to the site showing a federal court will meet next month to decide the fate of the growing Mirena litigation. DrugRisks mission is to improve patient safety by providing the latest drug warnings,recalls, studies and legal news. This allows users to have informed discussions with their doctors about drug side effects and decide if they need legal advice, explains DrugRisk representative Ryan Mayer. DrugRisk has added information from the FDA showing more than 47,000 patients have filed AERS reports after suffering complications from the Mirena IUD.* Of these, 5079 involved dislocation and 1421 involved migration of the devices, which can perforate or damage the uterine wall.* In more than 6% of cases, patients required hospitalization or surgery. The resource center has also learned that the FDA warned Bayer, the maker of Mirena, about the marketing of the device in 2009, after they failed to disclose safety risks while claiming the devices could help busy moms with intimacy and make them look and feel great.** DrugRisk reported that, with litigation over Mirena perforation growing, … Continue reading →

Methamphetamine crystals in a bag. (AP Photo/DEA) Some of the negative side effects of taking methamphetamines begin only after users have stopped taking them, according to a recent study by University of Florida researchers. A study led by Dr. Habibeh Khoshbouei, an associate professor of neuroscience and psychiatry at the UF College of Medicine, showed that mice withdrawing from methamphetamines had memory loss and a decrease in neuronal activity two weeks after the withdrawal began -- the equivalent of one year in humans. The mice did not have the same symptoms while they were still taking the drugs. It is very well established that people who abuse meth show symptoms of neurodegeneration and psychosis, so long-term meth abuse can produce all sorts of problems, Khoshbouei said. Meth induces an uncontrolled release of dopamine, a neurotransmitter responsible for pleasure. It exposes the brain to too much dopamine, which feels good at the time but has both immediate and long-term consequences namely of killing neurons, said Dr. Jamie Smolen, an addiction psychiatrist at UF. Smolen added that the long-term use of meth might change receptors in the brain permanently, impairing memory, attention span and what is called executive function, or the ability … Continue reading →