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New Weight-Loss Drug Qnexa Shows Promise in Trial

Posted 17 days ago by Drugs.com

THURSDAY, May 10 – A new weight-loss drug that is awaiting approval from the U.S. Food and Drug Administration showed promising results in a recent international trial, researchers report. Volunteers who took Qnexa, a combination of the drugs phentermine and topiramate, experienced substantial weight loss, even if they had many weight-related health problems, the study found. The findings were reported this week during the European Congress on Obesity in Lyon, France. The 56-week clinical trial included 994 patients who took a placebo, 498 who took a medium dose of Qnexa, and 995 who took a high dose of the drug. Patients who took Qnexa had significantly greater weight loss than those who took the placebo, researchers Stephan Rossner, of the Karolinska Institute in Stockholm, Sweden, and Arya Sharma, of the University of Alberta in Edmonton, Canada, said in a news release from the ... Read more

Migraine Guidelines: What Works, What Doesn't

Posted 23 Apr 2012 by Drugs.com

MONDAY, April 23 – Dozens of medications are available to prevent debilitating migraine headaches, but most migraine sufferers don't use them, a new study finds. "Approximately 40 percent of people with migraines need preventive treatment, and only about one-third of them are actually getting it," said Dr. Stephen D. Silberstein, co-author of new guidelines developed by the American Academy of Neurology and the American Headache Society. The drugs include prescription, over-the-counter and herbal medications. Which will work best "depends on the patient," said Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. The guidelines, published in the April 24 issue of Neurology, were scheduled for presentation at the academy's annual meeting in New Orleans, April 21 to 28. Dr. Brian M. Grosberg, director of the Montefiore Headache Center in ... Read more

Prescription Meds Can Put on Unwanted Pounds

Posted 2 Mar 2012 by Drugs.com

FRIDAY, March 2 – Medications taken by millions of Americans for mood disorders, high blood pressure, diabetes and other chronic conditions can have an unhealthy side effect: weight gain. While other choices exist for some types of drugs, adjusting medications is not simply a matter of switching, said Ryan Roux, chief pharmacy officer with the Harris County Hospital District, in Houston. In the late 1990s, Dr. Lawrence Cheskin conducted early research on prescription medicines and obesity. "Some medicines make an early, noticeable difference, causing patients to become ravenously hungry, while changes are subtle for others. A few months taking them and you've gained 10 pounds," said Cheskin, now director of the Johns Hopkins Weight Management Center, in Baltimore. To help increase awareness, Roux and his pharmacist group have compiled a list of "weight-promoting" and "weight-neutral or ... Read more

FDA Weighs Fate of Qnexa for Weight Loss, Again

Posted 21 Feb 2012 by Drugs.com

TUESDAY, Feb. 21 – The U.S. Food and Drug Administration plans to take a second look at the weight loss pill Qnexa on Wednesday, after initially rejecting it because of concerns about heart problems and possible birth defects. While effective at reducing weight, the drug, manufactured by Vivus Inc., was denied approval in 2010 because of its potential side effects. An FDA advisory panel will now review two years of data; when advisers last voted on Qnexa, only one year's worth of follow-up data was available. The drug combines the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. Phentermine was once widely prescribed as the "phen" part of the fen-phen weight loss drug. This combo was withdrawn from the market after its use was linked to high blood pressure in the lungs and heart valve disease. The problems were related to the "fen" or fenfluramine part of ... Read more

New Guidelines Issued for Common Tremor Disorder

Posted 19 Oct 2011 by Drugs.com

WEDNESDAY, Oct. 19 – An antiseizure drug called primidone (Mysoline) and a high blood pressure drug called propranolol (Inderal) are the most effective medicines to treat shaking in people with essential tremor, according to an updated treatment guideline from the American Academy of Neurology. Essential tremor, which affects about 10 million people in the United States, is the most common type of tremor disorder and is often mistaken with other movement disorders such as Parkinson's disease. The condition usually starts after age 40 and affects the hands, head and voice. It can cause difficulties with daily activities such as eating, writing, shaving and sewing. Along with primidone and propranolol, other helpful medicines include the antiseizure drugs gabapentin (Fanatrex, Neurontin) and topiramate (Topamax), the high blood pressure drugs atenolol (Tenormin) and sotalol (Betapace, ... Read more

New Uses Found for Old Drugs

Posted 17 Aug 2011 by Drugs.com

WEDNESDAY, Aug. 17 – Many drugs already approved to combat certain illnesses may also be helpful in treating a slew of other seemingly unrelated health problems, a new study indicates. Researchers from the Stanford University School of Medicine used computers to pair drugs with all illnesses for which they might be beneficial. They argued their findings make the case for drug repositioning – or the use of existing drugs to boost progress on the development of new treatments – for other serious conditions. One high-profile example of how a drug can be used to treat conditions for which it was not originally intended involves Viagra. This medication was first developed to treat heart problems. It turned out that Viagra is also effective in treating erectile dysfunction as well as a lung disorder called pulmonary hypertension. The researchers from Stanford, however, sought to predict ... Read more

Newer Epilepsy Meds Less Likely to Cause Birth Defects: Study

Posted 17 May 2011 by Drugs.com

TUESDAY, May 17 – Newer epilepsy medications don't increase the risk of major birth defects in women taking these drugs during the first trimester of pregnancy, according to new research. But because the drugs are relatively new, further studies are needed to get a clearer picture of their safety profile, experts said. In a large study of children born in Denmark, including those exposed to newer anti-epileptic drugs, researchers found the rate of major birth defects was 3.2 percent for babies born to women taking the epilepsy medications and 2.4 percent for women not taking these drugs. "In a nationwide Danish study of more than 800,000 births, we found no support for an increased risk of birth defects following use of newer generation anti-epileptics in early pregnancy," said the study's lead author, Ditte Molgaard-Nielsen, an epidemiologist at Statens Serum Institute in Copenhagen. ... Read more

FDA: Risk of oral birth defects in children born to mothers taking topiramate

Posted 8 Mar 2011 by Drugs.com

SILVER SPRING, Md., March 4, 2011 - New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today. Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug. Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines. “Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug E ... Read more

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Epilepsy Drugs Don't Raise Suicide Risk, Study Shows

Posted 5 Aug 2010 by Drugs.com

WEDNESDAY, Aug. 4 – In 2008, the U.S. Food and Drug Administration required epilepsy medications to bear a warning label about an increased risk of suicidal behaviors. The move came after an agency review of 199 studies that found patients taking the drugs showed about twice the risk of suicidal behavior. But now a study of more than 5 million patients contradicts the FDA's findings. It suggests that the increased risk of suicide has more to do with the conditions for which these drugs are prescribed than the medications themselves. For the study, researchers in Spain and the United States evaluated the health records of primary care patients in England. They found that people with epilepsy who currently use an antiepileptic drug are at no greater risk of suicide-related events than those who aren't taking the medications. "In our opinion, in the long term, it is not the drugs ... Read more

FDA Medwatch Alert: Antiepileptic Drugs

Posted 5 May 2009 by Drugs.com

[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of ... Read more

FDA Adds Suicide Warning to Epilepsy Drugs

Posted 16 Dec 2008 by Drugs.com

TUESDAY, Dec. 16 – The U.S. Food and Drug Administration announced Tuesday that it was adding a label warning on heightened suicide risk for users of antiepileptic drugs. The move, which follows the advice last summer of an FDA advisory panel, stops short of slapping the strongest "black box" warning on this class of drugs, which includes widely used medications such as clonazepam (Klonopin), phenytoin (Dilantin) and topiramate (Topamax). "Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. But, he added, "patients who are currently taking an antiepileptic medicine should not make ... Read more

Related support groups: Klonopin, Lyrica, Lamictal, Topamax, Depakote, Keppra, Trileptal, Carbatrol, Tranxene, Zonegran, Di-Phen, Zarontin, Mysoline, Gabarone, Gabitril

FDA Medwatch Alert: Topamax (topiramate)

Posted 30 Sep 2005 by Drugs.com

[UPDATE November 10, 2005] Letters from Novartis Pharmaceuticals Corporation added below [UPDATE September 30, 2005] Letters from Ortho-McNeil Neurologics, Inc. added below [Posted 09/26/2005] AstraZeneca and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between Toprol-XL (metoprolol succinate) extended release tablets, indicated for the treatment of hypertension, long-term treatment of angina pectoris, and heart failure NYHA Class II or III, and Topamax (topiramate), a product of Ortho-McNeil Neurologics, Inc, indicated for the treatment of epilepsy and migraine prophylaxis. There have also been reports of medication errors involving confusion between Toprol-XL and Tegretol or Tegretol-XR (carbamazepine), products of Novartis Pharmaceuticals Corporation, indicated for the treatment of complex partial seizures, generalized tonic-clonic ... Read more

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FDA Medwatch Alert: Topamax (topiramate) Tablets/Sprinkle Capsules

Posted 30 Dec 2003 by Drugs.com

Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS sections of the prescribing information, notifying healthcare professionals that Topamax causes hyperchloremic, non-anion gap metabolic acidosis (decreased serumbicarbonate). Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. [December 2003 Read more

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FDA Medwatch Alert: Topamax (topiramate) Tablets/Sprinkle Capsules

Posted 10 Jul 2003 by Drugs.com

Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS sections of the prescribing information to provide updated information about oligohidrosis (decreased sweating) and hyperthermia, which have been reported in topiramate-treated patients. Oligohidrosis and hyperthermia may have potentially serious sequelae, which may be preventable by prompt recognition of symptoms and appropriate treatment.[July 9, 2003 Letter - Ortho-McNeil] PDF Format[June, 2003 Revised label - Ortho-McNeil] PDF Format Read more

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