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topiramate 14 articles

Few people are aware there are drugs available to help treat alcohol addiction

Over-the-counter nicotine patches and prescription drugs can help cigarette smokers kick the habit, but many people are not aware that there are drugs that can help curb one’s desire to drink alcohol. One reason is because the drugs are rarely prescribed, researchers say. Both acamprosate (Campral) and naltrexone (Revia) are approved by the Food and Drug Administration (FDA) – along with support from groups or psychological counseling – to help people avoid alcohol. Two other drugs – the painkiller nalmefene (Selincro) and the anti-seizure medication topiramate (Topamax) – are also occasionally prescribed off-label to treat alcohol addiction. “Most people with ... Read More

Johnson and Johnson, Janssen settle dozens of Topamax birth defects lawsuits

Johnson & Johnson and its subsidiary Janssen Pharmaceuticals have agreed to settle 76 lawsuits in Pennsylvania court over allegations that its anti-seizure and migraine drug Topamax caused birth defects in babies born to women who used the drug during pregnancy. News of the settlement comes a month after a Philadelphia County jury awarded $3 million in damages to the family of a 5-year-old who claimed the companies did not update the safety label of Topamax to reflect data that showed the drug increased the risk of cleft lip and cleft palate in newborn babies. Johnson & Johnson and Janssen also ... Read More

Anti-seizure drug Topamax approved for treatment of migraine headaches in teens

Federal drug regulators have approved the anti-seizure drug Topamax, known generically as topiramate, as a prophylaxis treatment for migraine headaches in teenagers ages 12 to 17. It is the first medication to be approved by the Food and Drug Administration (FDA) for adolescents. It is intended to be taken daily to prevent or reduce the frequency of migraines. Topamax first won FDA approval in 1996 to help prevent seizures. It was approved as a migraine prevention for adults in 2004. The expanded indication to include adolescents was based on a clinical trial involving 103 patients ages 12 to 17. Among ... Read More

European drug advisors reject Qsiva (Qsymia) diet drug based on safety concerns

Advisors for the European Union’s health agency has again recommended against approving the new weight loss drug Qsiva, made by Vivus Inc. The Committee for Medicinal Products for Human Use raised concerns about the cardiovascular safety of the drug, saying it would need more data proving its safety before it would reconsider its rejection. Qsiva is a combination of two FDA-approved drugs – phentermine, an appetite suppressant, and topiramate, used to treat epilepsy and migraines. Phentermine was part of the fen-phen diet drug cocktail that was popular in the 1990s, but was pulled from the market after studies showed the ... Read More

Diet pill Qsymia sales sluggish but analysts say pill has blockbuster potential

About 14,500 people have filled prescriptions for the new diet pill Qsymia since it hit the market in September, and the number of prescriptions are growing each month. Qsymia became the first weight loss pill to be sold in the U.S. since 1999. It is intended to be a lifelong treatment to help overweight and obese people manage their weight. Qysmia is a combination phentermine, a stimulant that acts as an appetite suppressant, and topiramate, a drug used to treat seizures. Analysts speculate that it could become blockbuster drug within a few years, generating sales of $1 billion or more. ... Read More

New diet drug Qsymia may be rejected by European drug regulators

Qsymia, first diet drug to be approved in 13 years by the U.S. Food and Drug Administration (FDA), may not get clearance from the European Medicines Agency because of the potential for heart problems. A European Union advisory panel is expected to rule on the weight loss treatment sometime next month, but the drug’s maker Vivus Inc. says it has been getting some cold vibes from the group. If rejected, Vivus says it will file a new marketing application or appeal the decision. Vivus wants to market Qsymia in Europe under the name Qsiva. This summer, the FDA approved Qsymia ... Read More

New diet drug Qsymia now available by prescription

The much anticipated diet drug Qsymia is officially on the market. Qsymia, made by Vivus, is one of two new weight loss drugs approved earlier this year by the Food and Drug Administration (FDA), becoming the first diet pills cleared by the FDA in more than 13 years. Unlike other drugs for weight loss, Qsymia, and new rival Belviq, are considered “life-long” treatments for obesity and should be used along with a diet and exercise program. Though both help users lose weight, they work in entirely different ways. Belviq contains the active ingredient lorcaserin, which works by activating a part ... Read More

Qsymia makers worry generics may take bite out of profits

Makers of the new obesity drug Qsymia have significantly scaled back their profit expectations after concerns that doctors may prescribe the drug’s ingredients separately rather than the drug itself. Vivus Inc., had estimated profits of as much as $3.6 billion per year, but scaled back its estimate to $1.2 billion, causing Vivus shares to tumble 7.7 percent earlier this week. Qsymia was one of two new long-term diet drugs approved by the Food and Drug Administration (FDA) earlier this year, making the drugs the first weight loss medications to be approved in 13 years. Qsymia was thought to be the ... Read More

FDA approves two life-long prescription diet drugs

Two new medications are the first in 13 years to be approved by the Food and Drug Administration (FDA) for long-term weight management. Marketed as Belviq and Qsymia, the prescription drugs are designed to be taken for the rest of a person’s life – along with a healthy lifestyle – for obese and overweight people who have been unsuccessful in getting their weight under control with diet and exercise. More than a third of adults in the United States are obese, and obesity contributes to a number of health conditions including high blood pressure, type 2 diabetes, and high cholesterol. “For ... Read More

FDA approves new medication for erectile dysfunction

Move over Viagra and Cialis, there’s a new erectile dysfunction drug in town, and it’s name is Stendra. The new drug, made by Vivus, got a nod from the Food and Drug Administration (FDA) just last week. It works in much the same way as its competitors, by inhibiting the same enzyme to increase blood flow to the penis. The drug will provide another option to the nearly 30 million men who suffer from erectile dysfunction, a condition in which men have difficulty getting or keeping an erection. Stendra, also known as avanafil, will come with the same side effect ... Read More