Alonso Krangle LLP Calls for Reauthorization of Legislation to Increase Pediatric Clinical Trials, Child Safety Information on Prescription Drug Labels

Share Article

According to New Study Published in Journal of the American Medical Association (JAMA), Half of Prescription Drug Labels Lack Information on Pediatric Use and Proper Dosage for Children.

Alonso Krangle LLP - Fighting for victims of personal injury cases, defective drug and medical device litigation, construction site accidents, nursing home abuse, medical malpractice negligence, qui tam/whistleblower actions and consumer fraud cases.

Alonso Krangle LLP - Fighting for victims of personal injury cases, defective drug and medical device litigation, construction accidents, nursing home abuse, medical malpractice, and whistleblower actions.

Alonso Krangle LLP is committed to protecting the legal rights of children who have been injured by unsafe products, especially dangerous drugs and defective medical devices.

Attorneys Andres Alonso and David Krangle, founding partners of Alonso Krangle LLP, a national law firm focused on child safety and child product liability injuries, are today calling for the renewal of legislation to increase pediatric clinical trials and require that child safety information be added to the labels of prescription drugs likely to be used to treat children. According to U.S. Food & Drug Administration (FDA) researchers, a study of over 500 medication labels from 2009 revealed that half lacked information regarding their use in children, including instruction on proper pediatric dosage. The study appears in the May issue of the Journal of the American Medical Association (JAMA). [abcnews.go.com/blogs/health/2012/05/08/how-do-docs-prescribe-kids-meds-guess/]

Alonso Krangle LLP is offering free lawsuit consultations to families of children injured by defective drugs, or children injured by unsafe products, dangerous toys, and defective medical devices. To discuss a potential lawsuit with one of the experienced and compassionate child safety lawyers at Alonso Krangle LLP, please contact us at 1-800-403-6191 or visit our website, FightForVictims.com.

The authors of the JAMA study said they conducted their analysis to gauge the effectiveness of legislation passed in the last decade to increase pediatric clinical trials and child safety information on drug labels. The Pediatric Research Equity Act allows the FDA to require drug companies conduct pediatric clinical trials if a drug is likely to be used widely in pediatrics. The Best Pharmaceuticals for Children Act gives incentives for drug companies to test their products on children. According to the FDA researchers, these laws have resulted in new pediatric labeling for almost 400 drugs as of March 2011. However, the current legislation is set to expire this year.

The JAMA study looked at 560 medications and found that only 231 included information regarding the drug’s safety and effectiveness in children and teens, including age-specific dosage information. Another 29 had dosing information for at least some younger age groups, but not all.

The remainder – 54 percent – lacked any useful pediatric information. Even after the research team took 100 medications that weren't relevant for use in children out of the equation, 44 percent still had no child-relevant labeling. What’s more, over half of drugs with new ingredients approved between 2002 and 2008 lacked specific information for safety and dosing in children.

According to Alonso Krangle, LLP, a lack of clear child safety information, including proper dosage instructions, on prescription drug labels poses a serious public health threat. In April, Harvard researchers reported that four out of every five children hospitalized in the U.S. are treated with drugs that have never been tested in children and are FDA-approved only for adults. For this reason, the firm is calling on the U.S. Congress to reauthorize both the Pediatric Research Equity Act and Best Pharmaceuticals for Children Act as soon as possible, preferably before this important legislation expires later this year. [pediatrics.aappublications.org/content/129/5/e1291.abstract?sid=ee5636cc-a1a6-459e-879c-5b9cca808829]

Alonso Krangle LLP is committed to protecting the legal rights of children who have been injured by unsafe products, especially dangerous drugs and defective medical devices. If your child sustained a serious injury from a medication, medical device or other defective product, your family may be able to file a lawsuit seeking compensation from the manufacturer, supplier and others who brought the dangerous item to market. To discuss a potential lawsuit with one of the experienced and compassionate child safety lawyers at Alonso Krangle LLP, please contact us at 1-800-403-6191 or visit our website, http://www.FightForVictims.com.

About Alonso Krangle LLP

Andres Alonso and David Krangle, attorneys with almost 40 years of collective legal experience, have focused their law practice on the handling of significant product liability cases, defective drug and medical device litigation, construction site accidents, nursing home abuse, medical negligence, qui tam/whistleblower actions and consumer fraud cases. A national law firm representing injured victims throughout the U.S., Alonso Krangle LLP is headquartered in Long Island, New York, with offices in New York City, and plans to open additional locations in New Jersey.

For more information about Alonso Krangle or to join the fight and be a part of our team, please contact us at 1-800-403-6191 or visit our website, http://www.FightForVictims.com.

Contact:
Alonso Krangle LLP
445 Broad Hollow Road
Suite 205
Melville, New York 11747
Toll-FREE 1-800-403-6191
Tel: 516-350-5555
Fax: 516-350-5554

Share article on social media or email:

View article via:

Pdf Print

Contact Author

David Krangle

Andres Alonso
Visit website