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FDA Medwatch Alert: Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects

Posted 2 Jul 2015 by Drugs.com

ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids. In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years, and that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions ... Read more

Related support groups: Cough, Codeine, Cold Symptoms, Cheratussin AC, Tylenol with Codeine, Tylenol with Codeine 3, Statuss, Promethazine with Codeine, Codeine/Promethazine, Fioricet with Codeine, Fiorinal with Codeine, Robitussin-AC, Acetaminophen/Codeine, Tylenol with Codeine 4, Phenergan with Codeine, Poly-Tussin, Iophen, Iophen-C NR, Guiatuss AC, Fiorinal with Codeine III

That Lingering Cough Could Be Bronchitis

Posted 21 May 2015 by Drugs.com

THURSDAY, May 21, 2015 – If you have a cold that lasts a long time or a persistent cough, you could have bronchitis and should see a doctor, a doctor says. "We see a lot of cases of bronchitis at our immediate care centers," said Dr. Khalilah Babino, an assistant professor of family Medicine at Loyola University Chicago Stritch School of Medicine. Although most cases are caused by the common cold virus or influenza virus, bronchitis can lead to more serious conditions, such as pneumonia, which require medical treatment, she added. Symptoms of bronchitis – a serious disorder of the lower respiratory tract – include fever, chills, chest congestion and productive cough that lasts more than five days, Babino said. "The cough can last two to three weeks and could be an indicator of a more serious condition. If symptoms persist for more than seven to 10 days or symptoms start to get worse, ... Read more

Related support groups: Hydrocodone, Cough, Codeine, Bronchitis, Mucinex, Pneumonia, Guaifenesin, Dry Cough, Dextromethorphan, Robitussin, Benzonatate, Cough and Nasal Congestion, Delsym, Acetylcysteine, Tussin, Tessalon, Tessalon Perles, Mucomyst, Potassium Iodide, NAC

Vernalis and Tris Pharma Receive FDA Approval for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex)

Posted 1 May 2015 by Drugs.com

May 1, 2015 – Vernalis plc and Tris Pharma Inc. today announce that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III). Tuzistra XR is an extended-release oral suspension combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1(H1) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older. It is indicated for oral use, with or without food, and is to be dosed every 12 hours. Tuzistra XR is the only codeine based extended-release oral suspension cough-cold treatment in a U.S. prescription cough cold market which sees 30-35 million prescriptions written each year and is estimated to be worth ... Read more

Related support groups: Cough, Codeine, Cold Symptoms, Upper Respiratory Tract Infection, Chlorpheniramine, Cough and Nasal Congestion, Chlorpheniramine/Codeine

Placebo Treatment May Quiet Kids' Cough

Posted 27 Oct 2014 by Drugs.com

MONDAY, Oct. 27, 2014 – Giving young children agave nectar or a placebo treatment of flavored, colored water both appear to help reduce cough symptoms at night more than not giving any treatment, according to a new study. "Many pediatricians suggest doing nothing for cough and cold symptoms other than maintaining hydration and perhaps giving acetaminophen or ibuprofen," said lead researcher Dr. Ian Paul, chief of the Division of Academic General Pediatrics at Penn State College of Medicine in Hershey, Pa. "It is possible that giving a sweet liquid 'placebo' is preferred for families and children than doing nothing or, even worse, taking an unnecessary antibiotic," he said, adding that this is a discussion families should have with their providers. Paul's research team compared three treatment types among 120 children under 4 years old who had a nighttime cough lasting less than a week ... Read more

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Too Much Codeine Still Prescribed to U.S. Kids: Study

Posted 21 Apr 2014 by Drugs.com

MONDAY, April 21, 2014 – Emergency room physicians still hand out hundreds of thousands of codeine prescriptions for children every year, despite warnings that kids' responses to codeine vary wildly and the drug can cause an accidental overdose, a new study finds. ER doctors issued about 560,000 to 880,000 prescriptions for codeine to kids each year between 2001 and 2010, according to an analysis of hospital survey data collected annually by the U.S. Centers for Disease Control and Prevention. "We have hundreds of thousands of children still getting codeine, even though there are better and safer alternatives available," said study author Dr. Sunitha Kaiser, an assistant clinical professor of pediatrics at the University of California, San Francisco (UCSF). The study was published online April 21 in the journal Pediatrics. These prescriptions continued to be handed out despite repeated ... Read more

Related support groups: Pain, Cough, Codeine, Cheratussin AC, Tylenol with Codeine, Tylenol with Codeine 3, Statuss, Promethazine with Codeine, Codeine/Promethazine, Fioricet with Codeine, Fiorinal with Codeine, Robitussin-AC, Acetaminophen/Codeine, Tylenol with Codeine 4, Phenergan with Codeine, Iophen, Iophen-C NR, Guiatuss AC, Fiorinal with Codeine III, Codeine/Phenylephrine/Promethazine

Health Tip: Dealing With a Child's Cough

Posted 27 Sep 2013 by Drugs.com

-- Parents may become fearful at the first signs of a child's cough. But experts say a cough is the body's way of protecting itself against respiratory damage. The American Academy of Allergy Asthma & Immunology offers this advice about coughs that develop in children: A lingering daytime cough that follows a viral respiratory infection probably doesn't need treatment, and should subside in a week or two. See the pediatrician if your child's cough lasts longer than you think it should. Also see the pediatrician if your child can't engage in daily activities because of the cough, or if your child is coughing up blood. Many cough medicines are not effective in children. Schedule a consultation with an allergist or immunologist if you think your child's cough may be triggered by allergies or asthma. Read more

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Many Parents Give Kids Cold Medicines When They Shouldn't, Survey Finds

Posted 23 Apr 2013 by Drugs.com

TUESDAY, April 23 – More than 40 percent of American parents give over-the-counter cough and cold medicines to kids under age 4 even though they're too young for such products, a new survey finds. In young children, these medicines can cause allergic reactions, increased or uneven heart rate, slow and shallow breathing, confusion or hallucinations, drowsiness or sleeplessness, convulsions, nausea and constipation. Since 2008, labels on cough and cold medicines have warned that they should not be given to children under age 4. The use of cough and cold medicines in children in that age group did not differ by parent gender, race/ethnicity or household income, according to the University of Michigan C.S. Mott Children's Hospital National Poll on Children's Health. The survey included 498 parents of children aged 3 and under. Children can get five to 10 colds a year, so parents often turn ... Read more

Related support groups: Cough, Sta-D, Cold Symptoms, NyQuil, Phenylephrine, Dry Cough, Dextromethorphan, Mucinex DM, Alka-Seltzer, Delsym, DayQuil, Daytime, Bromfed, Bromfed DM, C-Phen DM, Tylenol Cold, Tussin DM, Promethazine DM, Actifed, Rondec

Pernix Therapeutics Receives FDA Approval for Vituz

Posted 28 Feb 2013 by Drugs.com

THE WOODLANDS, Texas--(BUSINESS WIRE)--Feb 28, 2013 - Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration (FDA) approval of a new drug application (NDA) for Vituz Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate). Vituz is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. Cooper Collins, President and CEO of Pernix, said, “Vituz broadens our cough and cold product line and is our first NDA approved by the FDA, since we closed the acquisition of Hawthorn and Cypress at the end of December 2012. We look forward to the launch of this new treatment option for cough and cold symptoms, which is expected prior to the fall of this year.” Indication fo ... Read more

Related support groups: Cough, Cold Symptoms, Chlorpheniramine/Hydrocodone

Patient Education Helps Prevent Overuse of Antibiotics for Cough, Study Finds

Posted 18 Jan 2013 by Drugs.com

FRIDAY, Jan. 18 – Patient education in the form of brochures and posters helps reduce the overuse of antibiotics to treat bronchitis in teens and adults, according to a new study. The overuse of antibiotics to treat bronchitis could worsen trends in antibiotic resistance, the researchers noted. They said computer prompts alerting nurses to the need for patient education on the difference between bronchitis and pneumonia also are effective in reducing reliance on antibiotics. The study, led by Dr. Ralph Gonzales of the University of California, San Francisco, involved 33 primary care practices that are part of an integrated health care system in central Pennsylvania. At 11 practices, printed materials – including educational brochures and posters explaining the difference between bronchitis and pneumonia – were routinely offered to patients suffering from a cough. In 11 more ... Read more

Related support groups: Cough, Doxycycline, Bactrim, Azithromycin, Bronchitis, Cipro, Ciprofloxacin, Levaquin, Zithromax, Sulfamethoxazole, Erythromycin, Minocycline, Clarithromycin, Bactrim DS, Levofloxacin, Upper Respiratory Tract Infection, Avelox, Tetracycline, Biaxin, Sulfasalazine

Most Coughs Don't Respond to Antibiotics, Study Confirms

Posted 18 Dec 2012 by Drugs.com

TUESDAY, Dec. 18 – Commonly prescribed antibiotics don't help cure most coughs in adults, new research confirms. Patients with a cough or bronchitis are often prescribed antibiotics, and previous studies have had conflicting results about their effectiveness. For this study, researchers randomly assigned more than 2,000 adults complaining of a cough to take either the antibiotic amoxicillin for a week or an inactive placebo. Overall, the antibiotic was no more effective at relieving symptoms or their duration than the placebo, the study found. The findings also held among people who were older than 60. "The main message here is that antibiotics are usually not necessary for respiratory infections, if pneumonia is not suspected," said Dr. Philipp Schuetz of the Kantonsspital Aarau in Switzerland. "Only a few patients benefit from antibiotics and these may be identified with new blood ... Read more

Related support groups: Cough, Amoxicillin, Bronchitis, Amoxil, Amoxil Pediatric Drops, Trimox, Biomox, Moxatag, Apo-Amoxi, Amoxicot, DisperMox, Moxilin, Wymox

Antibiotics Don't Ease Coughs in Kids With Common Cold: Study

Posted 25 Oct 2012 by Drugs.com

WEDNESDAY, Oct. 24 – Children with a cough associated with the common cold should not be given antibiotics, according to a new study. Although they are not effective in treating this type of cough, researchers in Italy said many children are prescribed antibiotics anyway. Antibiotics are also overprescribed to children in the United States, other experts have said. The findings were presented Monday at the American College of Chest Physicians (ACCP) annual meeting in Atlanta. "In our experience, antibiotics are often prescribed by the general practitioner to treat cough in children, many times to pacify parents," study lead author Dr. Francesco de Blasio, of the Clinic Center Private Hospital in Naples, Italy, said in an ACCP news release. "However, antibiotics show very little effectiveness at treating cough due to your average head cold." It's not hard to understand why this can ... Read more

Related support groups: Cough, Cold Symptoms

Health Tip: Treating a Chronic Cough

Posted 26 Sep 2012 by Drugs.com

-- If you've had a cough that's lasted at least eight weeks, you may have a chronic cough. The best way to treat that cough depends on its cause. The American Academy of Family Physicians says possible causes of a chronic cough include: Being a smoker. Having allergies, including seasonal allergies or allergies to pets, plants, fumes, smoke or dust. Taking a medication that triggers coughing. Having asthma that isn't well-controlled by medication. Having heartburn. Read more

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Chronic Cough Responds to Epilepsy Drug, Study Finds

Posted 28 Aug 2012 by Drugs.com

TUESDAY, Aug. 28 – A drug commonly used to control epileptic seizures and pain, gabapentin, also appears to ease hard-to-treat chronic coughs, a new study says. Chronic cough affects 11 percent to 16 percent of the population, the researchers report. The exact cause is unknown, but it might relate to a malfunction in a part of the brain that causes coughing. Gabapentin works by suppressing that "cough center," they said. "It is effective and well-tolerated, and may provide significant relief and respite from such a physically and psychologically disabling condition," said lead researcher Nicole Ryan, a clinical research scientist at the University of Newcastle in Australia. "Gabapentin is a real treatment option for people with refractory chronic cough, especially for those with features of central sensitization." People with this kind of cough feel the need to cough when there is no ... Read more

Related support groups: Gabapentin, Cough, Neurontin, Gralise, Horizant, Gabarone, Fanatrex

Secondhand Smoke May Impair Children's Cough Reflex

Posted 20 Aug 2012 by Drugs.com

MONDAY, Aug. 20 – Secondhand smoke impairs children's vital cough reflex, a new study suggests. Researchers from the Monell Center in Philadelphia found exposure to secondhand smoke lowers kids' sensitivity to irritants that would normally make them cough. And because these children's lungs aren't protected through coughing, they are at greater risk for pneumonia, bronchitis and other respiratory diseases. Despite these increased risks, the study showed children exposed to secondhand smoke may be more likely to develop a smoking habit because experimentation with cigarettes may be less unpleasant for them. "Cough protects our lungs from potentially damaging environmental threats, such as chemicals and dust. Living with a parent who smokes weakens this reflex, one of the most vital of the human body," study co-director Julie Mennella, a developmental biologist at Monell, said in a news ... Read more

Related support groups: Cough, Smoking

Honey a Sweet Treatment for Kids' Night-Time Cough

Posted 6 Aug 2012 by Drugs.com

MONDAY, Aug. 6 – Instead of reaching for a commercial medicine when your child is coughing through the night because of a common cold, Israeli researchers suggest giving honey a try. A teaspoon or two of honey before bedtime can safely relieve the symptoms of an upper respiratory tract infection, they report. "The cough due to a viral [upper respiratory infection] is generally a self-limited disease," said study author Dr. Herman Avner Cohen, chairman of the Pediatric Community Ambulatory Care Clinic with Clalit Health Services in Petah-Tikva, Israel. "However, parents often [want] some active intervention," Cohen said. This often leads to the use of over-the-counter cough medications, which are potentially dangerous because of the possibility of accidental overdose, he said. For this reason, "honey may be a preferable treatment for the cough and sleep difficulty associated with ... Read more

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