FDA News

April 2009

FDA News

• FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely (April 28)The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

• SAMHSA and FDA Join to Educate the Public on the Safe Use of Methadone (April 28)The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Food and Drug Administration (FDA) today launched an initiative to help ensure the safe use of methadone. A prescription drug best known as a treatment for addiction and dependence on heroin and other narcotic pain medicines, methadone is also prescribed to treat moderate-to-severe chronic pain patients. The campaign responds to concerns about an escalating number of poisoning deaths linked to the improper use of this medication.

• FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans (April 27)The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.

• Raw Alfalfa Sprouts Linked To Salmonella Contamination (April 26)The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time.

• FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis (April 24) The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion.

• Updated FDA Action on Plan B (levonorgestrel) Tablets (April 22) On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court’s order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.

  Plan B is manufactured by Duramed Research, Inc. of Bala Cynwyd, Pa.

• FDA Researchers Contribute Insights into Avian Flu Virus (April 21) An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus.

  The findings by U.S. Food and Drug Administration scientists and collaborators better explain what part of the “bird flu” virus is seen by the immune system once a person becomes infected. As one result of this research, a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus.

• FDA Alerts the Public to Uncle Chen and Lian How Brand Expanded Recall (April 16)The U.S. Food and Drug Administration (FDA) is alerting the public to the expanded, voluntary recall by Union International Food Company (Union City, Calif.) of sauces, oils, and oil blends sold under the Uncle Chen and Lian How brands. The expanded recall is based on the investigation into the ongoing foodborne illness outbreak of Salmonella Rissen. It is in addition to the recall announced last month by the company of its dry spice products.

• FDA Imposes Restrictions on Coast IRB due to Violations (April 14)
• FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs (April 10) The U.S. Food and Drug Administration today 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.

• FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioid (April 9)
• FDA Approves Benzyl Alcohol Lotion for the Treatment of Head Lice (April 9)
• FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market (April 8)
• FDA Consumer Health Information Updates for This Week (April 8)

• On The Road Again: The FDA’s Mobile Laboratories
  http://www.fda.gov/consumer/updates/mobilelabs0309.html
  This article (with slide show) reveals how mobile labs help the FDA test food and drugs for contaminants.
• Slide Show: Take a Tour of the FDA’s Mobile Laboratories
  http://www.fda.gov/consumer/updates/mobilelabs_slide01.html
  Take a slide show tour and see how the FDA's mobile labs are protecting your health.
• Pistachio Recall Expanded
  http://www.fda.gov/consumer/updates/pistachios033109.html
  On April 6, 2009, Setton Pistachio, Terra Bella, Calif., expanded its recall of pistachio products.
• Insulin Pens are Not for Sharing
  http://www.fda.gov/consumer/updates/insulin_pens032509.html
  Insulin pens should not be used on multiple patients.
• FDA’s MedWatch Safety Alerts: March 2009
  http://www.fda.gov/consumer/updates/medwatch032309.html
  This article summarizes a few of the most recent safety alerts prompted by reports received by the FDA from health care professionals and their patients.

• FDA to Review Medical Devices Marketed Prior to 1976 (April 8)
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• FDA Approves Coartem Tablets to Treat Malaria (April 8)The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).
  

• FDA Serves Warrant for Inspection of Westco Fruit and Nuts Inc. (April 8) At the request of the U.S. Food and Drug Administration, U.S. Marshals today executed an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts.

  The company, which produces and distributes peanuts and peanut products, received peanuts and peanut product from the Peanut Corporation of America (PCA), a Georgia company that recalled products in January due to concerns of Salmonella contamination.

• FDA Clears Rapid Test for Avian Influenza A Virus in Humans (April 7) The U.S. Food and Drug Administration today cleared for marketing a new, more rapid test for the detection of influenza A/H5N1, a disease-causing subtype of the avian influenza A virus that can infect humans. The test, called AVantage A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results.

• Routine Tests Uncover Listeria Contamination in Strubs Norwegian Style Steelhead Salmon (April 7) The U.S. Food and Drug Administration today warned consumers not to eat Strubs Norwegian Style Sliced Smoked Steelhead Salmon in 300 gram packages because of potential contamination with the bacterium Listeria monocytogenes. L. monocytogenes is a foodborne pathogen that can cause serious illness and death.

• FDA Approves Generic Topamax to Prevent Seizures (April 1) The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures. Topiramate tablets in several different strengths have been approved to be marketed by the following firms: Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Barr Laboratories Inc., TEVA Pharmaceuticals USA, Ranbaxy Laboratories Ltd., CIPLA Ltd., Glenmark Generics Ltd., Cobalt Laboratories, Apotex Inc., Zydus Pharmaceuticals USA, Aurobindo Pharma Ltd., Torrent Pharmaceuticals Ltd., Invagen Pharmaceuticals Inc., Unichem Laboratories Ltd., Sun Pharmaceuticals Ltd. and Pliva Hrvatska.

CDC In the News

CDC Responds to Swine Flu Outbreak Among Humans
Last week the CDC activated its Emergency Operations Center to augment the CDC ongoing investigation of human cases of swine influenza A (H1N1). CDC is working very closely with officials in states where human cases of swine influenza A (H1N1) have been identified, as well as with health officials in Mexico, Canada and the World Health Organization.

Published: April 27, 2009