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FDA Approves Return of Drug for Morning Sickness
Posted 9 Apr 2013 by Drugs.com
WASHINGTON (AP) — A treatment pulled off the market 30 years ago has won Food and Drug Administration approval as the only drug specifically designated to treat morning sickness. That long-ago safety scare proved to be a big false alarm. Monday's decision means a new version of the pill once named Bendectin will return to U.S. pharmacies — this time called Diclegis. U.S. doctors have had no officially approved treatment for morning sickness since lawsuits forced Bendectin off the market in 1983. But the drug's main ingredients are vitamin B6 (pyridoxine) and an over-the-counter antihistamine called doxylamine (Unisom), and obstetricians often advised pregnant women how to mix up the right dose themselves. Diclegis is made by a Canadian company that has long sold the medication in that country, and plans to begin U.S. sales in June. NewsEdge Read more
Related support groups: Doxylamine, Pyridoxine
FDA Approves Diclegis for Pregnant Women Experiencing Nausea and Vomiting
Posted 9 Apr 2013 by Drugs.com
April 8, 2013 – The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy, such as dietary and lifestyle modifications. These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest and avoiding smells that can trigger nausea. “Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Res ... Read more
Related support groups: Nausea/Vomiting, Doxylamine, Pyridoxine, Nausea
Diclegis Approved for Morning Sickness
Posted 9 Apr 2013 by Drugs.com
TUESDAY, April 9 – Diclegis (doxylamine succinate and pyridoxine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat nausea and vomiting associated with "morning sickness" during pregnancy. The drug was sanctioned for pregnant women who haven't responded to other therapies, such as eating smaller meals, eating lower-fat foods and avoiding smells that can prompt nausea, the agency said in a media release. Diclegis was evaluated in 261 adult women with morning sickness who had been pregnant between seven and 14 weeks. Women who took the drug had less nausea and vomiting than those who took a placebo. Studies also showed the drug didn't pose a threat to the fetus, the FDA said. The most common side effect of the drug – with a typical once-daily dose of two pills – was potentially severe drowsiness. Women who take Diclegis should avoid driving or operating ... Read more
Related support groups: Nausea/Vomiting, Doxylamine, Pyridoxine
FDA Allows Return of Once-Banned Morning Sickness Pill
Posted 9 Apr 2013 by Drugs.com
TUESDAY, April 9 – A morning-sickness medication that was banned 30 years ago has won U.S. Food and Drug Administration approval under a new name. In its new form, the drug – formerly called Bendectin and now renamed Diclegis – is the only medication specifically approved to treat the stomach upset many women suffer from during pregnancy. In the intervening decades between the drug's withdrawal from the market and its re-approval on Tuesday, the medicine has undergone rigorous scrutiny and is now deemed safe by the FDA. Obstetricians welcomed the announcement. "The nausea and vomiting of early pregnancy can range from mild to debilitating," said Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City. "Patients will welcome more options for treatment with the reintroduction of Bendectin." Their nausea may not disappear completely, but "it will hopefully ... Read more
Related support groups: Nausea/Vomiting, Doxylamine, Pyridoxine
Is a Better Sleeping Pill on the Way?
Posted 3 Apr 2013 by Drugs.com
WEDNESDAY, April 3 – A new class of sleep medications appears to help people fall asleep without causing grogginess the next day, researchers say. These new medications – known as dual orexin receptor antagonists (DORA) – target a more specific region of the brain than popular sleep drugs such as Ambien and Lunesta, promoting sleep without affecting learning and memory (also called "cognition"), according to the new research. "We've shown that these compounds improve sleep at doses that don't impact cognition," said Jason Uslaner, lead author of a study published in the April 3 issue of Science Translational Medicine. Uslaner is director of In Vivo Pharmacology at Merck & Co., which funded the study. Merck already has one such drug, suvorexant, under review by the U.S. Food and Drug Administration (FDA). More than 30 million Americans struggle to get a good night's sleep, and about ... Read more
Related support groups: Xanax, Klonopin, Ambien, Ativan, Valium, Clonazepam, Lorazepam, Alprazolam, BuSpar, Benadryl, Diazepam, Hydroxyzine, Zolpidem, Buspirone, Melatonin, Temazepam, Diphenhydramine, Lunesta, Vistaril, Restoril
Another Drug 'Take-Back Day' Scheduled for Saturday
Posted 26 Apr 2012 by Drugs.com
THURSDAY, April 26 – The fourth National Prescription Drug Take-Back Day is scheduled for Saturday from 10 a.m. to 2 p.m., the U.S. Drug Enforcement Administration says. The event gives Americans an opportunity to safely dispose of unwanted and unused prescription drugs. At the third Take-Back Day last October, participants turned in more than 377,000 pounds (188.5 tons) of unwanted or expired medications at more than 5,300 sites located in all 50 states. In total, the three Take-Back Days have taken in nearly 1 million pounds of prescription drugs during the past 13 months. "The amount of prescription drugs turned in by the American public during the past three Take-Back Day events speaks volumes about the need to develop a convenient way to rid homes of unwanted or expired prescription drugs," DEA administrator Michele Leonhart said in an agency news release. "The DEA remains hard at ... Read more
Related support groups: Suboxone, Xanax, Methadone, Oxycodone, Percocet, OxyContin, Adderall, Hydrocodone, Vicodin, Morphine, Klonopin, Norco, Fentanyl, Lortab, Ambien, Phentermine, Opana, Ativan, Valium, Subutex
Accidental Medication Poisonings in Kids on the Rise
Posted 16 Sep 2011 by Drugs.com
FRIDAY, Sept. 16 – Despite ongoing prevention efforts, a growing number of young children are being accidentally poisoned with medications, according to new research. The study, which was based on data reported to the American Association of Poison Control Centers between 2001 and 2008, found that medication poisoning among children aged 5 and under increased by 22 percent, although the number of children in the United States in this age group rose by only 8 percent during the study period. "The problem of pediatric poisoning in the U.S. is getting worse, not better," Dr. Randall Bond, of Cincinnati Children's Hospital Medical Center, said in a hospital news release. In conducting the study, which is scheduled for publication in the Journal of Pediatrics, the researchers reviewed information on over 544,000 children who landed in the emergency department due to medication poisoning ... Read more
Related support groups: Suboxone, Xanax, Methadone, Oxycodone, Percocet, OxyContin, Hydrocodone, Vicodin, Morphine, Klonopin, Norco, Lisinopril, Fentanyl, Lortab, Ambien, Opana, Ativan, Valium, Subutex, Codeine
FDA Bans Unapproved Prescription Cough, Cold and Allergy Meds
Posted 2 Mar 2011 by Drugs.com
WEDNESDAY, March 2 – The U.S. Food and Drug Administration said Wednesday that it plans to remove about 500 unapproved prescription cough, cold, and allergy medicines from pharmacy shelves. These drugs have not been evaluated by the FDA for safety and effectiveness, and they may be riskier to take than approved over-the-counter (OTC) drugs that treat these same conditions, agency officials explained. "This action is necessary to protect consumers from the potential risks posed by unapproved drugs, because we don't know what's in them, whether they work properly or how they are made," Deborah M. Autor, director of the agency's Office of Compliance at the Center for Drug Evaluation and Research, said during a morning news conference. Of particular concern are drugs that have time-release formulations, Autor said. "We know from experience that these type of products are complicated to ... Read more
Related support groups: Benadryl, Mucinex, Sta-D, Diphenhydramine, Pseudoephedrine, Sudafed, Tylenol PM, Cold Symptoms, Phenylephrine, NyQuil, Cheratussin AC, Guaifenesin, Mucinex DM, Night Time, Dextromethorphan, Chlorpheniramine, Robitussin, Dry Cough, Claritin-D, Tussionex Pennkinetic
Psychotropic Medications Associated With Risk of Falls in Older Adults
Posted 1 Dec 2009 by Drugs.com
CHICAGO, Nov. 23, 2009 - Older adults who take several types of psychotropic medications—such as antidepressants or sedatives—appear more likely to experience falls, according to an analysis of previous studies reported in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. More than 30 percent of individuals older than 65 will fall at least once a year, and falls and their complications are the fifth-leading cause of death in the developed world, according to background information in the article. Each year, 85 percent of all injury-related hospital admissions and more than 40 percent of nursing home admissions are related to falls, and the annual costs related to falls and their complications are estimated to be in the billions of dollars worldwide. Both internal and external risk factors contribute to falls, and medications have previously been i ... Read more
Related support groups: Xanax, Lexapro, Zoloft, Cymbalta, Wellbutrin, Effexor, Klonopin, Prozac, Celexa, Ambien, Paxil, Ativan, Valium, Clonazepam, Trazodone, Pristiq, Citalopram, Effexor XR, Amitriptyline, Lorazepam
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