Statement from CHPA on Today's FDA Advisory Committee Meeting on Dextromethorphan

/PRNewswire/ -- The Consumer Healthcare Products Association issued the following statement on the Drug Safety and Risk Management Advisory Committee's recommendation not to schedule over-the-counter (OTC) medicines containing dextromethorphan:

"Today's FDA advisory committee decision not to recommend scheduling OTC cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of over-the-counter medicines containing dextromethorphan.

"Today, 40 million American households turn to dextromethorphan-containing OTC medicines each year to relieve their cough symptoms. More common than heartburn and severe headaches, cough burdens the sufferer, families, and society (as a very rapid way to spread virus). Because of cough's widespread prevalence and effects, it's vital for people to have OTC access to safe and effective self-treatment. Dextromethorphan is in nearly 90 percent of OTC cough suppressants sold today. We agree that dextromethorphan should not be scheduled as a controlled substance.

"We do, however, recognize the need for continued education to keep any abuse levels low. We also have long called for federal legislation that would limit purchases of bulk quantities of dextromethorphan to manufacturers who are registered with FDA. We believe that a statutory ban on sales of dextromethorphan medicines to those under 18 would limit abuse. We also believe legislation must be matched with targeted research-based education, which has been shown to be effective in reducing substance abuse.

"Research over the past 35 years clearly shows that targeted educational interventions focusing on increased parental awareness and increased perceptions of the risks and social disapproval are the most effective abuse-reduction strategies. Since 2003, we have had educational programs focusing on the dangers of misuse of over-the-counter medicines, including those containing dextromethorphan. We will continue to expand upon these programs through our comprehensive Abuse Mitigation Plan that targets the key risk factors leading to abuse, along with limiting the various points where teens are accessing these medicines.

"It is our hope that FDA will follow the advisory committee's guidance and weigh the important public benefit of continued over-the-counter access to these medicines in making its final recommendation."

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Researchers Find Common Respiratory Virus Hijacks Lung Cells to Stay Alive

/PRNewswire/ -- Approximately one-half of all infants are infected with the respiratory syncytial virus (RSV) during the first year of life, and almost all children have been infected at least once by the time they reach their second birthday. Researchers at West Virginia University have discovered what makes RSV such a severe and persistent illness.

Senior author Giovanni Piedimonte, M.D., and his team have discovered that RSV prompts the release of a molecule that keeps the invaded cells alive despite the infection. The mechanism allows infected cells to survive for a longer period of time while they continue to produce viral particles, thus contributing to the severity and persistence of the infection.

Research results are published in the current issue of the journal PLoS ONE.

Inflammation of the airways caused by RSV often results in wheezing, cough and respiratory distress, creating the most common respiratory infection in infancy or childhood. Each year, an estimated 125,000 infants in the United States are hospitalized with RSV, the leading cause of infant hospitalization.

"There is still no effective therapy or medical treatment for RSV infection. While often mild, it still is responsible for the deaths of hundreds of infants in the United States each year," said Dr. Piedimonte, chair of the WVU Department of Pediatrics and physician-in-chief of WVU Children's Hospital. "The virus also strikes in nursing homes and causes deaths in the elderly population, so understanding how it works is critical."

Piedimonte said up to 500 infants may die of the infection each year. RSV may also predispose children to long-term health problems such as asthma. Other groups at high risk for severe RSV disease include the elderly, adults with underlying respiratory or cardiac disease, and those with a compromised immune system.

"Viruses must find a way to survive inside the host, and in this case RSV has found a way of keeping alive the cells that they infect," Piedimonte explained. "The virus invades the cell, which then produces a small molecule called NGF, or nerve growth factor. NGF allows the cell to survive while the virus reproduces itself. Finally, the cell explodes releasing new viral particles ready to infect the neighboring cells."

In determining how the virus instructs the infected cell to prolong its life, the researchers may have established a blueprint for development of new anti-viral drugs aimed at interfering with the action of NGF, Piedimonte said. He added that RSV may prefer the lower respiratory tract specifically because the smaller airways there allow for more efficient production of NGF.

"The interesting part of the RSV infection is that the viruses induce NGF production within an hour of coming into contact with the human cells - that is, even before they start multiplying," said the paper's lead author, Sreekumar Othumpangat, Ph.D., a researcher in the WVU Pediatric Research Institute.

Children born prematurely as well as those with chronic lung or heart disease are at higher risk for severe RSV infections.

The laboratory studies were done using human cells. Now that Piedimonte's team has discovered how RSV prolongs the life of its host cell, they are proceeding with other studies to see if they can pinpoint the same mechanism in common cold and influenza viruses.

The paper's other authors are Laura F. Gibson, deputy director of the Mary Babb Randolph Cancer Center at WVU, and Lennie Samsell, a research assistant in the Pediatric Research Institute.

The article, "NGF Is an Essential Survival Factor for Bronchial Epithelial Cells during Respiratory Syncytial Virus Infection," is available online at http://dx.plos.org/10.1371/journal.pone.0006444.

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FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs

The U.S. Food and Drug Administration recently announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.

Both Neilgen, which does business as Unigen Pharmaceuticals Inc. (Unigen), and Advent are contract manufacturers and distributors of more than 25 different unapproved drug products each. The more than 50 unapproved drug products primarily include prescription cough and cold products. The unapproved drugs manufactured by Unigen and/or Advent include, but are not limited to:

* RE All 12 Suspension;
* BP Allergy Junior Suspension;
* PE Tann 20 mg/CP Tann 4 mg Suspension;
* BP New Allergy DM Suspension;
* D-Tann CT Tablets;
* B-Vex D Suspension;
* Histex SR; and
* Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets.

The unapproved drugs manufactured by these companies have not undergone the FDA's drug approval process, so their safety and effectiveness have not been established and the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.

Consumers in possession of any of these products should discontinue using them and discuss FDA-approved treatments with their health care professional. Pharmacists should discontinue dispensing these products.

The defendants signed a consent decree that orders them to destroy their existing drug supply, and prohibits them from commercially manufacturing and distributing any new drugs without the FDA's approval. Further, the firms must retain outside experts who will advise them on appropriate compliance standards with U.S. current Good Manufacturing Practice (cGMP) requirements for drugs, and obtain written authorization from FDA to resume operations. The consent decree also authorizes the FDA to order the defendants to cease operations or take other corrective action in the event of future violations and further subjects the defendants to liquidated damages of $1,000 for each violation. An additional $5,000 per day, up to $1 million per year, can be levied for each violation, if the defendants fail to comply with any of the provisions of the decree. The consent decree was entered by Chief Judge Benson E. Legg in the U.S. District Court of Maryland on April 9, 2009.

“The FDA's key enforcement priorities include shutting down manufacturers and distributors of unapproved drugs. Drugs not in compliance with cGMP cause great risk to public health,” said Michael Chappell, acting associate commissioner for the FDA's Office of Regulatory Affairs.

The FDA sought an injunction after the defendants failed to comply with previous warnings and continued to manufacture drugs in violation of federal law. Multiple FDA inspections of both the Unigen and Advent facilities found that the companies continued to manufacture unapproved new drugs. FDA inspections also revealed numerous and recurring violations of the cGMP requirements for drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Both Unigen and Advent failed to respond adequately to issues raised by the FDA's inspection findings.

“To protect the American public, companies that continue to market unapproved drugs must be required to cease that illegal activity,” said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research. “It is critical that only drugs that are safe, effective and manufactured in accordance with good manufacturing practices be allowed into the U.S. marketplace.”

In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs - Compliance Policy Guide” (CPG). The CPG makes clear that companies may not market drugs that require approval without first establishing in applications that the products are safe and effective. Among priorities in the CPG are enforcement actions against manufacturers that violate provisions of the FD&C Act.

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FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

Over the last year, FDA has been working on several fronts to address the safe use of nonprescription OTC cough and cold medicines in children.

FDA has held two public meetings to hear from stakeholders and consumers on the issue, most recently, a public hearing that focused on labeling of these products on Oct. 2, 2008. In January of this year, FDA issued a nationwide Public Health Advisory recommending that these products not be used in children under the age of two because of the risk of serious and potentially life-threatening side effects.

Another part of the agency's work includes outreach to other public health agencies, consumer and patient groups companies that manufacture these products, and CHPA.

FDA will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of these products and to develop educational materials for parents and consumers. The Agency will also continue to reach out to the scientific community to obtain more up-to-date information and scientific data about the effects of these products in children so that it can take the appropriate regulatory steps moving forward.

All these areas are vital to support the development and review of data regarding the safe and effective use of these products.

FDA is proceeding with its rulemaking process to update the existing OTC monograph for cough and cold products for children, and will consider input from the recent hearing of Oct. 2. The rulemaking process affords additional opportunity for the submission of data and public comment.

Until all these issues are resolved, FDA continues to recommend to parents and caregivers the following:

• Do not give children medications labeled only for adults.
• Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
• Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children.
• Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose. This will help you understand what symptoms the "active ingredients" in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
• Be very careful if you are giving more than one medicine to a child. If you are giving more than one medicine to a child make sure that they do not have the same type of "active ingredients." If you use two medicines that have the same or similar active ingredients, a child could get too much of an ingredient and that may hurt your child. For example, do not give a child more than one medicine that has a decongestant.
• Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of these products can lead to serious and potentially life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system, seizures and other adverse events.
• Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use common household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines.
• Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child’s symptom(s) such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick.

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