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It’s Official! Feds Nix Cold and Cough Meds for Kids Under Six

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After weeks of speculation, the Food and Drug Administration (FDA) took the additional step of recommending that cold and cough medicines used by parents for generations no longer be administered to children under six.

While the resolution of the FDA is "not binding," it will surely impact how such medications are marketed, displayed and used.

The recommendation applies to medications containing any of the following ingredients: decongestants, antitussives (against cough) and antiistamines.

Not only to the over-the-counter medicines for cough and colds apparently not work for kids, but there are documented incidents of the meds leading to death in the recipient kids (generally due to parental misuse).

In a separate action, the American Academy of Pediatrics recently backed a petition by pediatricians urging banning such medications from kids under six.

Source: FDA

 

New Drug Isentress (Raltegravir) Approved by FDA for HIV Treatment

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The U.S. Food and Drug Administration (FDA) has approved raltegravir tablets for treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

Raltegravir is the first agent of the pharmacological class known as HIV integrase strand transfer inhibitors, designed to interfere with the enzyme that HIV-1 needs to multiply. Raltegravir, sold under the trade name Isentress, received a priority review by the FDA.

"This is an important new product for many HIV-infected patients whose infections are not being controlled by currently available medications," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.

When used with other anti-HIV medicines, raltegravir may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight off other infections.

FDA’s approval of raltegravir is based on data from two double-blind, placebo-controlled studies in 699 HIV-1 infected adult patients with histories of extensive antiretroviral use. A greater proportion of the patients who received raltegravir in combination with other anti-HIV drugs experienced reductions in the amount of HIV in the blood, compared with patients who received placebo in combination with other anti-HIV drugs.

The most common adverse events reported with raltegravir were diarrhea, nausea, and headache. Blood tests also showed abnormal elevated levels of a muscle enzyme in some patients receiving raltegravir. Caution is advised when using raltegravir in patients at increased risk for certain types of muscle problems, including those who use other medications that can cause muscle problems.

Patients taking raltegravir may still develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV-1 infection. The long-term effects of raltegravir are not known, and its safety and effectiveness in children less than 16 years of age has not been studied.

Raltegravir also has not been studied in pregnant women. Women who are taking HIV medications when they get pregnant are advised to talk with their physician or other health care professional about use of this drug during pregnancy, and about registering with the Antiviral Pregnancy Registry if they use raltegravir.

Raltegravir is distributed by New Jersey-based Merck & Co., Inc.

Source: U.S. Food and Drug Administration (FDA)

List of Withdrawn Pediatric Cold Medicines

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The following medicines are among those that have been withdrawn from the market by their manufacturers for treatment of coughs and colds in infants. If you have any of these medicines at home, it would be wise to discard them to avoid accidental administration.

If you wish to use any of these medications for children between the ages of 2 -6, please contact your pediatrician for additional information. Be advised that their use in the 2-6 age group, while not covered by the current voluntary withdrawal, remains controversial.

Manufactured by Johnson & Johnson:

  • Concentrated Infants’ Tylenol Drops Plus Cold
  • Concentrated Infants’ Tylenol Drops Plus Cold & Cough
  • Pediacare Infant Drops Decongestant (PSE)
  • Pediacare Infant Drops Decongestant & Cough (PSE)
  • Pediacare Infant Dropper Decongestant (PE)
  • Pediacare Infant Dropper Long-Acting Cough
  • Pediacare Infant Dropper Decongestant & Cough (PE)

Manufactured by Novartis:

  • Triaminic Infant & Toddler Thin Strips Decongestant
  • Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough

Manufactured by Prestige Brands Holding

  • Little Colds Decongestant Plus Cough
  • Little Colds Multi-Symptom Cold Formula

Manufactured by Wyeth Labs

  • Dimetapp Decongestant Infant Drops
  • Dimetapp Decongestant Plus Cough Infant Drops
  • Robitussin Infant Cough DM Drops

Source: FDA

Baby Cold Medicines Withdrawn

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In a voluntary drug withdrawal initiated by the FDA, major manufacturers of over-the-counter cold and cough medicine targeted to infants have withdrawn their products.

The stated reason was to avoid misuse by misinformed parents. The withdrawal only affects products for infants, leaving products for use in children 2 and older on the market.

Further research, and further negotiations between pharmaceutical companies and the FDA will decide the fate of cold medicines marketed to the 2 – 6 year old population.

In the New York Times, Dr. Daniel Fratarelli, a pediatrician on the American Academy of Pediatric’s committee on drugs stated in regard to pediatric cough and cold medicines, "I don’t recommend their use in any child… These medicines don’t help, they may hurt, so don’t use them."

Bisphosphonates for Osteoporosis May be Associated with Atrial Fibrillation

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Atrial fibrillation may be associated with the use of bisphosphonates such as Reclast and Fosamax used to treat Osteoporosis, according to an article in a recent issue of the The New England Journal of Medicine. Atrial fibrillation is a heart rhythm disorder.

Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis. Bisphosphonates are also used to slow bone turnover in patients with Paget’s disease of the bone and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer.

There are 7 FDA-approved bisphosphonates: alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel W/Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa).

The New England Journal of Medicine article describes increased rates of serious atrial fibrillation (defined by the authors as life-threatening or resulting in hospitalization or disability) in two different studies of older women with osteoporosis treated with the bisphosphonates, Reclast and Fosamax.

In both studies, more women who received one of the bisphosphonates (Reclast-1.3% or Fosamax-1.5%) reportedly developed serious atrial fibrillation as compared to women who received placebo (Reclast study-0.5%, Fosamax study-1.0%). In both studies, the rates of all atrial fibrillation (serious plus nonserious) were not significantly different between groups treated with bisphosphonate versus placebo.

The FDA has reviewed some safety data and requested additional data to further evaluate the risk of atrial fibrillation in patients who take bisphosphonates.

According to the Food and Drug Administration, the FDA has reviewed spontaneous post-marketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation.

In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, the FDA evaluated the possible association between atrial fibrillation and the use of Reclast.

Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

Atrial fibrillation is a heart rhythm disorder common in individuals 65 years old and older, the same age range of many of the patients studied in the article published in The New England Journal of Medicine. Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, the FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.

The FDA says it is seeking additional data to allow for an in-depth evaluation of the atrial fibrillation issue for the entire class of bisphosphonates. It may take up to 12 months to complete the evaluation at which time FDA will communicate the conclusions and any resulting recommendations to the public. Moreover, FDA is continuing to monitor spontaneous post-marketing reports of atrial fibrillation reported in patients who have taken bisphosphonates.

The FDA urges both healthcare professionals and patients to report side effects from the use of bisphosphonates to the FDA’s MedWatch Adverse Event Reporting program.

This information in this article reflects the FDA’s current analysis of available data concerning these drugs. The FDA has not necessarily concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products.

FDA is considering, but has not reached a conclusion yet about whether this information warrants any regulatory action, and will provide additional updates when more information is available.

Sources:

  • FDA, "Early Communication of an Ongoing Safety Review," October 1, 2007
  • New England Journal of Medicine, May 3, 2007

Deaths Linked to Cephalon’s Cancer Pain Drug, Fentora

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After receiving reports of deaths and other serious side effects, FDA is alerting consumers and health care professionals to concerns about the use of Fentora (fentanyl buccal) tablets, a potent opioid pain medication.

Fentora is used only for treating breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it—those who take a regular, daily, around-the-clock narcotic pain medicine. Breakthrough pain is intense increases in pain that occur rapidly, even when opioid pain-control medication is being used.

People who develop tolerance to narcotic pain medicines are more resistant to the dangerous side effects of these medications than those who take narcotic pain medication less frequently.

The deaths reported indicate that some cancer patients

  • should not have been prescribed this medicine
  • were prescribed the wrong Fentora dose
  • took too many Fentora doses
  • received Fentora as a substitute for another fentanyl-containing product that is not equal to Fentora

Important Safety Information

  • Ask your doctor if you are opioid-tolerant before taking Fentora. The drug should only be used for breakthrough pain in opioid-tolerant patients with cancer.
  • Fentora should not be used to treat any type of short-term pain, including headaches or migraines, pain after an operation, or pain due to injury.
  • People who only take narcotic pain medications occasionally should not use Fentora.
  • Do not substitute Fentora for other fentanyl medicines, including Actiq. The dosage strength of fentanyl in Fentora is NOT equal to the same dosage strength of fentanyl in other fentanyl-containing products. Using the same dose can result in a fatal overdose.
  • Read the Medication Guide that comes with Fentora,and follow the directions exactly.

Watch For These Signs

Get medical attention right away if you have any of these signs:

  • trouble breathing or shallow breathing
  • tiredness, extreme sleepiness, or sedation
  • inability to think, talk, or walk normally
  • feeling faint, dizzy, or confused

FDA Actions

  • requested the manufacturer, Cephalon Inc., strengthen warnings and improve the dosing instructions in the drug’s product labeling and Medication Guide for patients
  • requested the company improve their education plan for prescribers and pharmacists
  • published a Public Health Advisory and Health Care Professional Sheet warning health care professionals that it is critical to follow Fentora’s product labeling
  • monitoring the Fentora issue closely and reviewing available information, including adverse events
  • working with the manufacturer to ensure the safest use of the medicine
  • providing updates as new information is available

Adverse events related to Fentora should be reported to MedWatch, the FDA’s voluntary reporting program.

Source: FDA

Shingles Vaccine: What You Need to Know

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According to a CDC "vaccine statement" a shingles vaccine was licensed in 2006, and in clinical trials it prevented shingles in 50% of people 60 years or older. In addition, the vaccine reduces the pain associated with the disease.

Shingles occurs only in someone who has had a case of chickenpox, or has had the chickenpox vaccine. The virus stays in one’s body and can reappear much later, causing the shingles outbreak. 

The main symptom is a painful rash, often with blisters. Other symptoms include fever, headache, upset stomach and chills.

 So what should one know in evaluating whether or not to get this vaccine?

First, no-one should get the vaccine if they have HIV /AIDS or another disease that affects the immune systom. Nor should they get the vaccine if they are under treatment with drugs, such as steriods, that affect the immune system. Nor should anyone under cancer treatment with radiation or chemotherapy, or any bone marrow disease (such as leukemia or lymphoma). Tuberculosis and pregnancy are other contraindications for the vaccine.

Then the choice is between you and your health care provider. According to the CDC "no serious problems have been identified with shingles vaccines."

For more information, contact your physician, local or state health department, or the CDC at www.cdc.gov.nip

SOURCE: Centers for Disease Control and Prevention

Botulism Warning from FDA – Canned French Cut Green Beansbo

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The FDA warned consumers this week to avoid specific brands of French Cut Green beans because the beans may not have been processed properly to eliminate the potential for botulism toxin.

So far there have been no illnesses associated with the products, but the potential for serious illness exists.
Anyone who has any of the following list of beans should immediately throw them away. If you are unable to read the code on the affected cans, it is recommended to dispose of them anyway.
The affected Lakeside cut green beans are sold nationwide under the following labels: Albertson’s, Happy Harvest, Best Choice, Food Club, Bogopa, Valu Time, Hill Country Fare, HEB, Laura Lynn, Kroger, No Name, North Pride, Shop N Save, Shoppers Valu, Schnucks, Cub Foods, Dierbergs, Flavorite, IGA, Best Choice and Thrifty Maid. The specific codes (top line of can code) involved are: EAA5247, EAA5257, EAA5267, EAA5277, EAB5247, EAB5257, ECA5207, ECA5217, ECA5227, ECA5297, ECB5207, ECB5217, ECB5227, ECB5307