Showing posts with label oseltamivir. Show all posts
Showing posts with label oseltamivir. Show all posts

Sunday, November 16, 2014

Bad Medicine, Can You Trust Big PHarma, Clinical Trial Data Or Even FDA?

I was searching for information on cold / flu season that is ahead of us. I did find some information but I got stuck at "Bad Medicine". It is hard even to think about this after reading an article on Newsweek. The following is an excerpt from the article and have left me totally confused. Follow the link after the jump for the complete article.
Millions have taken Tamiflu and still living but if Tamiflu does nothing, and there’s even a slight chance of life-threatening side effects, why was it approved? And why continue to prescribe it? That’s what the Cochrane Collaboration argued in a report it published in April.
Do you still want Tamiflu this cold / flu season. Looks like only Tamiflu, I would take is the fake Tamiflu that appeared in 2005, an export from China, at lease it had Vitamin C.

On the morning of March 2, 2005, a 14-year-old Japanese girl woke up scared. At first she thought someone was outside the house watching her, but then she decided the stranger must be inside. She wandered restlessly and, despite the cold weather, threw open all the windows. Later, over a meal, she declared, “The salad is poisoned.” Two days later, she said she wanted to kill herself.
This teenager with no history of mental illness was diagnosed with delirium. The night before the hallucinations started, she began taking an anti-influenza drug called Tamiflu (generic name: oseltamivir), which governments around the world have spent billions stockpiling for the next major flu outbreak.
But evidence released earlier this year by  Cochrane Collaboration, a London-based nonprofit, shows that a significant amount of negative data from the drug’s clinical trials were hidden from the public. The Food and Drug Administration (FDA) knew about it, but the medical community did not; the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as regulators, had recommended the drug without being able to see the full picture. When results from those unpublished trials finally did emerge, they cast doubt over whether Tamiflu is as effective as the manufacturer says.
..........
That Japanese girl, whose case was detailed in an FDA report, did not kill herself. But at least 70 people have died, many of them by suicide, after Tamiflu-induced episodes. The deaths were almost surreal: A 14-year-old who took Tamiflu jumped off a balcony, and a 17-year-old on the drug ran in front of a truck. Scientists documented other cases of “psychopathic events,” including a South Korean girl who temporarily developed bipolar disorder and an 8-year-old Japanese boy who wouldn’t answer to his name and began to growl.

Big Pharma Plays Hide-the-Ball With Data NewsWeek
fake Tamiflu that appeared in 2005

Thursday, June 17, 2010

Counterfeit Tamiflu Sold On Internet! And Is Dangerous To Patients Allergic To Penicillin.

Tamiflu: Counterfeit ( “Generic Tamiflu” ) Product Sold on Internet
product is dangerous to patients allergic to penicillin.

Audience: Consumers, Pharmacists
[Posted 06/17/2010]

Issue: FDA notified consumers and healthcare professionals 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. Patients who are allergic to penicillin products 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.
Background: 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. 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
Recommendation: 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 visiting the OCI website (http://www.fda.gov/OCI).
Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Online: www.fda.gov/MedWatch/report.htm
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178
  • 06/17/2010] News Release - FDA]

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