Drug Topics - December 3, 2007 - (Page 7) 7 uate the safety data and has requested additional data to further investigate the risk, estimating that the review will take approximately four months to complete. Until that time, the agency urges healthcare professionals to consider the potential risks when using cefepime and to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program at 1-(800) 332-1088. Lawsuit blames infant’s death on OTC cough, cold products An Illinois woman who found her son dead in his crib is suing two drugmakers, claiming their failure to warn consumers about the dangers of OTC cough and cold products contributed to his death. Filed Nov. 14 in Lake County Circuit Court, the lawsuit accuses the Walgreen Co. and McNeil Consumer Healthcare, a unit of Johnson & Johnson, of misleading parents about the safety of children’s cough and cold medicines, specifically those that contain dextromethorphan, a cough suppressant. The lawsuit was filed on behalf of Dimitria Alvarez of Bloomington, Ill., who gave her four-monthold son Infant Tylenol Cold Decongestant Plus Cough and Walgreen-brand Pediatric Drops-Cough Plus Cold. Both medications contain dextromethorphan. Alvarez’s son died from dextromethorphan intoxication; tests revealed he metabolized the ingredient slowly, leading to a lethal buildup. Alvarez’s lawsuit states that neither drugmaker warned consumers about the dangers of dextromethorphan and marketed the OTC products as safe for children. Walgreens, however, said the products’ labeling was in compliance with FDA standards and included use restrictions. “Walgreens was one of the first retailers to voluntarily remove these products last month out of an abundance of caution,” read a statement from the chain. “The FDA has found that these products are safe when used as directed, but should not be combined with other products with the same active ingredient.” Government and Law DEA issues final rule on Schedule II Rxs The Drug Enforcement Administration has issued a final rule allowing prescribers to give patients multiple prescriptions for up to a 90-day supply of Schedule II narcotics. Current laws do not permit the dispensing of more than a 30-day supply on a single Rx for Schedule II narcotics or refills, forcing many patients with chronic conditions to visit the doctor monthly to receive a new prescription. While some doctors had given multiple prescriptions to patients in the past, prior to the rule it was unclear whether the practice was legal. DEA received nearly 300 comments after the rule was first proposed, with the majority approving of the change. Under the new rule, which is set to go into effect Dec. 19, prescribers can give patients multiple dated Rxs for the same Schedule II drug that when combined do not add up to more than a 90-day supply. Pharmacists will not be able to fill any of the Rxs before the date on the prescription. Feds seize $2 million worth of ‘cosmetic’ eye product U.S. Marshals have seized 12,682 applicator tubes of Age Intervention Eyelash, a product the FDA claims could cause vision problems. Authorities estimated the seized tubes to be worth about $2 million. Jan Marini Skin Research Inc., the San Jose, Calif.-based seller and distributor of the product, has touted Age Intervention Eyelash as a way to grow longer lashes. But the FDA considers the product to be an unapproved and misbranded drug. The agency claims the product contains bimatoprost (Lumigan, Allergan), a drug used to treat elevated eye pressure. Bimatoprost patients who use Age Intervention Eyelash can damage their optic nerves, which can lead to poor vision and possibly blindness. Consumers, dermatologists, and others who have Age Intervention Eyelash should immediately discontinue using the product and discard it. Health Net investigated for denying coverage to poor kids Connecticut officials are investigating whether Health Net improperly sent denial-of-care messages to pharmacists for medications for low-income children. According to a report in the Hartford Courant, state Attorney General Richard Blumenthal has started an investigation and is calling for sanctions against the managed healthcare company. The company provides health benefits to approximately 6.7 million people nationwide and is one of four companies that had contracted with Connecticut to provide benefits to Medicaid beneficiaries. According to the report, Health Net sent “not covered” messages to pharmacies that falsely led some pharmacists to believe the medications were not covered, when the medications only required prior authorization. The state HUSKY Medicaid program had previously asked two of the other providers, Anthem and WellCare, to cease sending the same type of message. Anthem stopped immediately, while WellCare expected to change the practice by Dec. 1. DT http://www.drugtopics.com/drugtopics/Drug+Topics+Daily+News/Several-companies-voluntarily-withdraw-infant-coug/ArticleStandard/Article/detail/464886?contextCategoryId=10239&searchString=children?s%20OTC%20cough%20and%20cold http://www.courant.com/news/local/hc-ctdrugs1115.artnov15,0,194446.story
Table of Contents Feed for the Digital Edition of Drug Topics - December 3, 2007 Contents Do People Sue People who Counsel? New Standard Issued for Pseudoephedrine Tracking Latest News Roundup Drug Topics - December 3, 2007 Drug Topics - December 3, 2007 - Contents (Page 1) Drug Topics - December 3, 2007 - Contents (Page 2) Drug Topics - December 3, 2007 - Contents (Page 3) Drug Topics - December 3, 2007 - Do People Sue People who Counsel? (Page 4) Drug Topics - December 3, 2007 - New Standard Issued for Pseudoephedrine Tracking (Page 5) Drug Topics - December 3, 2007 - Latest News Roundup (Page 6) Drug Topics - December 3, 2007 - Latest News Roundup (Page 7)
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