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FDA Medwatch Alert: Mirapex (pramipexole): Drug Safety Communication - Ongoing Safety Review, Possible Risk of Heart Failure

Posted 19 Sep 2012 by Drugs.com

ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available. FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex than with placebo; however, these results were not statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex use. However, study limitations make it difficult to ... Read more

Related support groups: Restless Legs Syndrome, Parkinson's Disease, Mirapex, Pramipexole

Parkinson's Drugs Linked to Behavior Problems in Study

Posted 30 Mar 2011 by Drugs.com

TUESDAY, March 29 – Parkinson's disease drugs called dopamine agonists appear to cause impulse control problems in almost one-quarter of patients, says a new study. Previous research has linked dopamine agonists, which include Mirapex (pramipexole) and Requip (ropinirole), to impulse control disorders, such as gambling addiction and hypersexuality, and to compulsive behaviors, such as binge eating, overspending and excessive computer use. In this study, Mayo Clinic researchers analyzed Parkinson's disease patient records over two years. "What we found was that as many as 22 percent of patients during that two-year period had a new-onset impulse control disorder," lead investigator and neurology fellow Dr. Anhar Hassan said in a Mayo Clinic news release. The higher the dose of dopamine agonist, the more likely a patient was to develop an impulse control disorder, the researchers found. ... Read more

Related support groups: Parkinson's Disease, Mirapex, Requip, Sinemet, Ropinirole, Emsam, Pramipexole, Azilect, Bromocriptine, Levodopa, Carbidopa, Cabergoline, Selegiline, Amantadine, Neupro, Parlodel, Stalevo, Dostinex, Requip XL, Carbidopa/Levodopa

Parkinson's Drugs Tied to Compulsive Behaviors

Posted 10 May 2010 by Drugs.com

MONDAY, May 10 – Medicines used to treat Parkinson's disease may increase the risk of impulse control disorders, such as problem gambling, compulsive shopping and binge eating, researchers warn. In a new study that included 3,090 patients being treated for Parkinson's at 46 movement disorder centers in the United States and Canada, the researchers found that 13.6 percent of the patients had impulse control disorders. These impulse disorders included gambling (5 percent), compulsive sexual behavior (3.5 percent), compulsive shopping (5.7 percent) and binge eating (4.3 percent), and nearly 4 percent of the patients had two or more of these disorders. Impulse control disorders were more common among patients taking dopamine agonist medications (17.1 percent) than in those not taking the drugs (6.9 percent), the study authors found. Other factors associated with impulse control disorders ... Read more

Related support groups: Parkinson's Disease, Mirapex, Requip, Sinemet, Ropinirole, Emsam, Pramipexole, Azilect, Bromocriptine, Levodopa, Carbidopa, Cabergoline, Selegiline, Amantadine, Neupro, Parlodel, Stalevo, Dostinex, Requip XL, Carbidopa/Levodopa

Once-Daily Mirapex ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease

Posted 24 Mar 2010 by Drugs.com

RIDGEFIELD, Conn., March 23 /PRNewswire/ – Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily Mirapex ER (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease (PD), which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure. "In a pivotal trial of patients with advanced Parkinson's disease, Mirapex ER not only demonstrated significant symptom improvement, but also increased the number of hours during which people with advanced Parkinson's disease had better mobility," said Anthony Schapira, M.D., head of department and chairman of Clinical Neurosciences Specialties, The Institute of Neurology, University College London, London, UK. "With ... Read more

Related support groups: Parkinson's Disease, Mirapex

FDA Approves Once-Daily Mirapex ER for the Treatment of Early Parkinson's Disease

Posted 23 Feb 2010 by Drugs.com

RIDGEFIELD, Conn., Feb. 22 /PRNewswire/ – Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease (PD). Mirapex ER is not indicated in advanced PD. Parkinson's disease is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes. "Mirapex ER for early Parkinson's disease is a positive development in the treatment of this disease. This new, once-daily treatment has a more convenient dosing schedule, offering greater flexibility as someone with early Parkinson's disease plans his or her day," said Robert Hauser, M.D., professor of ... Read more

Related support groups: Parkinson's Disease, Mirapex

Cutting Parkinson's Drug Dose Linked to Withdrawal Effects

Posted 14 Jan 2010 by Drugs.com

WEDNESDAY, Jan. 13 – Reduced dosages of dopamine agonists, drugs routinely used to treat Parkinson's disease, can cause symptoms similar to those experienced by addicts in withdrawal, such as anxiety, panic attacks, pain, dizziness and drug cravings, researchers say. The symptoms of what the researchers have dubbed "dopamine agonist withdrawal syndrome" have been linked to a disruption in levels of dopamine in the brain, according to the study published in the Jan. 12 issue of the Archives of Neurology. "Like cocaine and methamphetamines, dopamine agonists work by stimulating the reward pathways in the brain," senior study author Dr. Melissa J. Nirenberg, said in a news release from Weill Cornell Medical Center. "For this reason, it makes sense that they would engender similar withdrawal symptoms, particularly in those with high cumulative drug exposure," explained Nirenberg, associate ... Read more

Related support groups: Parkinson's Disease, Mirapex, Requip, Sinemet, Ropinirole, Pramipexole, Emsam, Azilect, Levodopa, Bromocriptine, Carbidopa, Selegiline, Amantadine, Neupro, Parlodel, Stalevo, Sinemet CR, Carbidopa/Levodopa, Requip XL, Comtan

Parkinson's Drugs Can Trigger Unhealthy Behaviors

Posted 10 Apr 2009 by Drugs.com

FRIDAY, April 10 – A class of Parkinson's disease drugs called dopamine agonists can cause patients to develop destructive behaviors such as compulsive gambling or hypersexuality, says a new study. Mayo Clinic researchers found that one in six patients taking therapeutic doses of dopamine agonists, such as pramipexole and ropinirole, developed unhealthy behaviors. But decreasing the dosage of these drugs may eliminate the problem. For their study, the researchers analyzed the medical records of 267 Parkinson's disease patients treated at the Mayo Clinic in Rochester, Minn., between 2004 and 2006. Of those patients, 66 were taking dopamine agonists, including 38 who were taking therapeutic doses (doses expected to be at least minimally beneficial). Seven of the 38 patients taking therapeutic doses of dopamine agonists developed compulsive gambling or hypersexuality after they started ... Read more

Related support groups: Parkinson's Disease, Mirapex, Repreve

Parkinson's Treatment Drugs Even Out Over Long Term

Posted 11 Mar 2009 by Drugs.com

WEDNESDAY, March 11 – Two drugs – levodopa and pramipexole – used to treat early stage Parkinson's disease each have advantages and disadvantages, but their overall impact appears to even out over a long period of treatment. That's the conclusion of a new study that included hundreds of patients in Canada and the United States. "Clinicians and patients often struggle with what is the right initial approach to treating Parkinson's disease. This study tells us that, over the long haul, patients on the different drugs end up at roughly the same place in terms of their level of disability and quality of life," lead author Dr. Kevin Biglan, a neurologist at the University of Rochester Medical Center in New York, said in a school news release. The two drugs use different mechanisms to counteract the decline in the production of dopamine in the brain that causes Parkinson's symptoms. ... Read more

Related support groups: Parkinson's Disease, Mirapex, Dopar

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Related Condition Support Groups

Restless Legs Syndrome, Periodic Limb Movement Disorder, Parkinson's Disease

Mirapex Patient Information at Drugs.com