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FDA Medwatch Alert: Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

Posted 20 Aug 2017 by Drugs.com

[Posted 08/18/2017] ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.   BACKGROUND: The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release. RECOMMENDATION: Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall ... Read more

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Swimming Lessons: For Starters, Watch Out for Germs in the Water

Posted 5 Jul 2017 by Drugs.com

WEDNESDAY, July 5, 2017 – A dip in a pool, stream or lake on a hot summer day is refreshing, but take some precautions to avoid bacteria and parasites that might lurk in the water. "One of the worst offenders is the kiddie wading pool," said Dr. Christopher Ohl, a professor of infectious diseases at Wake Forest Baptist Medical Center in Winston-Salem, N.C. "Warm, shallow water and kids in swim diapers – which don't do a good job of containing feces – can create a perfect breeding ground for water-borne infections even though the water is chlorinated," he said. "The best way to prevent young children from getting sick is to keep them from swallowing that water." Ohl offered some other tips: For starters, keep children who have had any type of gastrointestinal illness away from pools or water parks for several days to prevent contamination of the water. Don't swallow the water when ... Read more

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Nasal 'Nerve Block' May Help Ease Kids' Migraines

Posted 5 Mar 2017 by Drugs.com

SUNDAY, March 5, 2017 – Kids and teens who suffer with migraines may find relief from a nasal "nerve block" that's commonly used in adults with the debilitating headaches, a new study suggests. During the procedure, a catheter is placed in each nostril and inserted until it reaches a bundle of nerves at the back of the nose. At that point, an anesthetic is released that deadens those nerves, thus relieving the headache pain. "The treatment does not require needles and often gives relief in just minutes, and relief can last for up to months," said lead researcher Dr. Robin Kaye, from Phoenix Children's Hospital. "Migraine headaches are really common in the pediatric population, and affect up to 12 percent of kids over the age of 12," she noted. These headaches can be debilitating for kids, and especially for teenagers, Kaye said. "When kids have these, it prevents them from ... Read more

Related support groups: Migraine, Migraine Prevention, Migraine Prophylaxis, Maintain, Lidoderm, Orajel, Anbesol, Pramoxine, Emla, Xylocaine Jelly, Phenol, Caladryl, Lanacane, Bactine, Nupercainal, Caladryl Clear, Zilactin Toothache, Solarcaine, Boil Ease Pain Relieving, Lidocaine Viscous

Health Tip: Getting Your Child Vaccinated

Posted 22 Dec 2016 by Drugs.com

-- Vaccinations are a necessary part of keeping your child healthy, but the pain and fear may be difficult to endure. The American Academy of Pediatrics suggests: Talk to the pediatrician about ways to manage your child's pain. Distract a young child during the shot by singing a song, blowing bubbles or playing a game. Act the doctor about using a numbing spray or cream. Breast-feed or offer a pacifier to babies during vaccination. Stay calm and reassure your child that everything is OK. Read more

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How to Ease the Pain of Infant Vaccinations

Posted 12 Dec 2016 by Drugs.com

MONDAY, Dec. 12, 2016 – Infant vaccinations are no fun. But anesthetic cream can take away some of the sting, new research suggests. After testing several techniques, researchers determined the best recipe for minimizing babies' discomfort includes lidocaine cream at the site of the injection, a little sugar by mouth and parental soothing. "Vaccinations cause acute distress for both infants and their parents, contributing to vaccination avoidance. However, there are gaps in knowledge about what is the best way to alleviate pain during vaccination," said study co-author Dr. Anna Taddio. She is a pharmacist and senior associate scientist at the Hospital for Sick Children in Toronto. The study included 352 healthy infants who received scheduled vaccinations during their first year. The babies were randomly assigned to one of four groups. In one group, parents received video instruction on ... Read more

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Retail Prices of Dermatology Drugs Skyrocket

Posted 25 Nov 2015 by Drugs.com

WEDNESDAY, Nov. 25, 2015 – Patients using prescription creams, gels, sprays and pills for skin conditions may shell out substantially more at the pharmacy than they did just six years ago, a new study suggests. Between 2009 and 2015, retail prices of brand-name dermatologic drugs rose 401 percent, on average, study authors reported Nov. 25 in JAMA Dermatology. Even generics have succumbed to price inflation, up 279 percent between 2011 and 2014, based on the drugs surveyed. Price increases for skin treatments far outpaced the general inflation rate of 11 percent during the six-year study period, the researchers said. "Cancer drugs were the worst in terms of the numbers" – up 1,240 percent or nearly $11,000 over the six-year study period – primarily because of two medicines, said Dr. Steven Rosenberg, voluntary professor of dermatology at the University of Miami Miller School of ... Read more

Related support groups: Monistat, RID, Monistat 3, Eczema, Monistat 7, Voltaren Gel, Dermatitis, Clobetasol, Contact Dermatitis, Therapeutic, Mupirocin, Efudex, Bactroban, Drysol, Maintain, Sulfur, Hypercare, Epiduo, Retin-A, Fluocinonide

FDA Medwatch Alert: Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain

Posted 30 Jun 2014 by Drugs.com

ISSUE: FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death. Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have r ... Read more

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Numbing Medications Can Harm Teething Babies, FDA Warns

Posted 28 Jun 2014 by Drugs.com

THURSDAY, June 26, 2014 – Teething infants can come to serious harm or even death from certain "gum-numbing" medications, according to a new warning from the U.S. Food and Drug Administration. The agency said Wednesday that local anesthetics known as viscous lidocaine, or benzocaine-containing teething products, should never be used for teething children, except under the advice and supervision of a health care professional. Viscous lidocaine contains a local anesthetic in a gel-like syrup. It requires a prescription and is typically used to treat mouth ulcers that can occur in patients undergoing chemotherapy. Parents who happen to have viscous lidocaine on hand may be tempted to use it to help teething babies, but they should not do so, the FDA said in a news release. There have been reports of teething babies suffering overdoses of viscous lidocaine, according to the Institute for ... Read more

Related support groups: Oral and Dental Conditions, Maintain, Lidoderm, Orajel, Anbesol, Xylocaine Jelly, Bactine, Lanacane, Zilactin Toothache, Solarcaine, Anbesol Gel, Lidocaine Viscous, Boil Ease Pain Relieving, RectiCare, Orabase Baby Teething Gel, Dermoplast, Zilactin-B, Medicone, Solarcaine Aerosol, Play Longer

Pain Patches Making Gains in U.S.

Posted 22 Jan 2011 by Drugs.com

FRIDAY, Jan. 21 – Americans suffering from muscle pain are used to taking a pill or rubbing in a cream to help soothe their aches. But a new form of pain relief seems to be catching on: analgesics delivered through a medicated patch placed directly where it hurts. The U.S. Food and Drug Administration approved the country's first over-the-counter, pain-relieving transdermal patches in 2008. But the patches, marketed under the brand name Salonpas, are nothing new. They've been sold in various countries in Asia since the 1930s, according to their manufacturer, the Japanese firm Hisamitsu Pharmaceutical. "Salonpas is the Western world catching up with Asia," said Dr. Rick Rosenquist, a professor of anesthesia and director of pain medicine at the University of Iowa Carver College of Medicine and chairman of the American Society of Anesthesiologists' committee on pain medicine. "If you are ... Read more

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