FDA Warns About Fraudulent Tamiflu

/USNewswire/ -- The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.

There is no FDA-approved generic drug for the prescription product Tamiflu.

The FDA bought the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however.

"A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient."

The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, "Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules" and "Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD."

Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.

Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info

The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989, or by visiting the OCI website (http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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Tamiflu Overdose? Consequences?

From time to time over the last few months, we seem to stumble across children who were given the wrong dosage of Tamiflu. Are there long lasting adverse side effects to this?

Read the heart wrenching story of this young child who was given an adult dose of Tamiflu--- and then see what you think.

If anyone else has a similar experience, please contact Olivia's mom directly....

Tamiflu Overdose

Olivia was given 2.5 times the children's dose of Tamiflu. Since that time, she has developed neurological problems. In addition, the patient information sheet with the Tamiflu has also been revised.

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Community Pharmacists Report Supply Shortages, Insurance Red Tape in Growing Fight against H1N1 Flu

(BUSINESS WIRE)--Community pharmacists have stepped up to meet the shortage of Tamiflu by compounding doses for children suffering from the H1N1 flu virus, but they are struggling with supply problems and insurance plans, according to the National Community Pharmacists Association.

Tamiflu’s manufacturer, Roche, asked pharmacists to compound the medicine until supplies improve. The time-intensive process involves extracting powder from capsules, calculating the quantity of medicine, and mixing the right amount with liquid, such as cherry syrup, to produce a suspension with the appropriate prescribed strength for young children.

Over a recent 48-hour period, 80 community pharmacists from around the country told NCPA about their experiences compounding Tamiflu. Nearly half (48%) reported preparing 25 or more suspension compounds since Sept. 1. Virtually all (97%) experienced difficulty in obtaining commercial Tamiflu suspension and many (48%) said the same about Tamiflu capsules, consistent with a front-page story in The Washington Post.

Most prescription coverage is administered by pharmacy benefit managers (PBMs) and 61% of pharmacists surveyed had difficulty adjudicating claims with them for compounded Tamiflu. Most commonly mentioned were the big three – CVS Caremark, Express Scripts, Inc. and Medco Health Solutions, Inc. – but nearly every PBM was identified as a source of difficulty.

Experts advise starting antiviral treatment as quickly as possible. But one pharmacist said, “We had several children that are ‘covered’ by the federal employee [health benefits] program [administered by CVS Caremark] and were told that this compound requires prior authorization which can take from 24 to 72 hours to obtain.”

“Compounding has long been a specialty of independent community pharmacists, and they’re working overtime against H1N1,” said NCPA Executive Vice President and CEO Bruce T. Roberts, RPh. “They’ve helped countless children and won the gratitude of just as many parents.”

“Unfortunately, this is harder than it should be,” Roberts added. “We hope insurance plans and PBMs will reexamine their claims processes to ensure kids get relief as quickly as possible.”

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Children Prescribed Tamiflu Could Get Wrong Dose

TT Note: It seems like so many parents are rushing to the doctor with children who are exhibiting flu like symptoms. Please be aware that the dosing for Tamiflu could be wrong. Be sure to double check everything with your pharmacist.

Medical and public health officials should be alerted to the serious potential for dosing errors in children prescribed Tamiflu® due to confusion when trying to follow the medication label and using the prepackaged dosing syringe, warns Emory University health literacy researcher Ruth Parker, MD, in the Sept. 23 online edition of the New England Journal of Medicine.

Parker, lead author of the special article and professor of medicine in the Emory School of Medicine, and colleagues say parents and caregivers may face difficulty calculating the correct dosage of Tamiflu® (oseltamivir) Oral Suspension to administer to their children because of misaligned instructions on the pharmacy label, the manufacturer's printed label, the accompanying Consumer Medication Information and the dosing syringe packaged with the Tamiflu®.

In the article, Parker, Kara Jacobson, MPH, of Emory's Rollins School of Public Health, and colleagues provide the example of a 6-year-old recently prescribed Tamiflu® for H1N1 influenza. While the medication bottle specified dosage in volume units (¾ of a teaspoon twice a day), the syringe prepackaged with the medication was marked in mass units (milligrams). It required a complex calculation for the parents to convert teaspoons to milligrams to determine just how much medication the child should receive.

"It is critical that immediate steps are taken to improve the prescribing instructions for this drug in children to ensure its safe use," says Parker. "We recommend that all pharmacies are instructed to ensure that the label instructions for use are in the same dosing units as those on the measurement device dispensed with Tamiflu® (oseltamivir)."

Tamiflu® is an antiviral medication prescribed to help stop the spread of the flu virus inside the body. It is typically given within a couple of days of a patient experiencing flu-like symptoms. It also can be used to prevent flu in someone who may have been exposed to the virus but is not yet displaying symptoms.

Parker says there is a need to improve instructions on medication labels beyond Tamiflu® Oral Suspension. She and colleagues suggest that all medication-measuring devices for children be changed to include volumetric dosage markings (milliliters or teaspoon). In addition, all materials (e.g. package insert, Consumer Medication Information, package label, and stick-on container label dosing instructions) should contain clear, consistent information that patients can understand and follow for safe and effective medication use.

"We view this as an issue at the intersection of patient safety and health literacy," says Parker.

In addition to Parker and Jacobson, study authors were: Michael S. Wolf, PhD, MPH, of the Feinberg School of Medicine, Northwestern University; and Alastair J.J. Wood, MD, of Symphony Capital LLC and Weil Cornell School of Medicine.

The article, "Serious Risk of Confusion in Dosing Tamiflu Oral Suspension in Children," published online Sept. 23 by the New England Journal of Medicine, can be viewed at www.nejm.org and h1n1.nejm.org. It will be published in print at a later date.

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