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FDA Warning on Toxic Head Lice Drugs

The maker of Linade Shampoo and Lindane Lotion,  head lice treatments has stopped promoting the drugs since a December Food & Drug Administration (FDA) warning that chastised Morton Grove Pharmaceuticals for minimizing the rare, but very serious, risks of the insecticide-based head lice drugs,

The FDA warning cites concern over some of the information drug maker Morton Grove Pharmaceuticals provided on websites and in mailed materials, including a statement by the company that treating head lice effectively requires two applications, several days apart. According to the FDA, this is “extremely alarming given that re-treatment with Lindane Shampoo can lead to increased exposure and possibly death.” According to the products’ warning label, hospitalizations, seizures, and deaths have been reported after the use of Lindane Shampoo and Lindane Lotion; the FDA requires that the prescriptions carry that warning. The warning label also cites “lindane toxicity, verified by autopsy” in two deaths: One infant and an adult who used the product to commit suicide. (more…)

NSF Gadolinium MRI Link Documented by CDC

The Centers for Disease Control (CDC) has documented several cases of  Nephrogenic Systemic Fibrosis (NSF)  associated with the use of Gadolinium contrast agents used in Magnetic Resonance Imaging (MRI). This latest NSF research  is just the latest to confirm the link between Gadolinium in MRI and NSF.

The CDC  NSF study began after May 2006 after nephrologists at an unidentified St. Louis hospital reported a cluster of NFS among patients treated in their dialysis units. The CDC conducted an investigation to determine the number of affected patients and identify risk factors for NFS. Of the 19 patients eventually included in the study, only five had no identified gadolinium exposure within 1 year preceding NFS diagnosis. However, of these, four had gadolinium exposure from 16 to 68 months preceding diagnosis. Thirteen patients had multiple gadolinium-containing contrast exposures during the preceding year. (more…)

Contamination Prompts NuCel Recall

NuCel-brand eye drops and eye-ear wash are subject to a voluntary, nationwide recall due to possible contamination, the U.S. Food and Drug Administration (FDA) announced today. According to the FDA,  an  testing of the NuCel products during an inspection  indicated there was bacteria and particulate matter in the defective drugs, presenting a health risk. Non-sterile eye drops pose a risk of causing eye infections, which in rare cases could lead to blindness.

No illnesses or injuries have been reported to date in connection with the recalled NuCel eye drops and ear wash.

(more…)

RU-486 Made by Chinese Company that Sold Tainted Cancer Drugs

Concerns over the safety of the “abortion pill” RU-486 were raised today, when it was learned that the Chinese company that supplies RU-486 to the US is accused of selling tainted drugs drugs in that country. Shanghai Hualian is the only supplier to the US of the “abortion pill”, but the Food & Drug Administration is downplaying worries over RU-486, saying that the “abortion pill” is not made at the same facility that produced tainted cancer drugs.

Problems with cancer drugs surfaced last summer after leukemia patients received injections of methotrexate and experienced leg pain and/or paralysis. Authorities recalled two batches of the drug, issuing mild warnings. Another cancer drug made in the same factory caused adverse reactions and investigators suspected contamination. In September, health and drug officials announced they found two drugs were contaminated with vincristine sulfate, a third cancer drug, during production. After issuing a nationwide alert, the government announced a wider recall and Shanghai’s drug agency sealed manufacturing units at the plant. There are an estimated 53 victims in Beijing and at nearly 200 nationwide and it remains unclear how many were paralyzed, as authorities have not released an official figure. About half of those injected still cannot walk. (more…)

Glaxo-Paid Consultant Admits Leaking Avandia Study

A physician who peer reviewed an Avandia study for the New England Journal of Medicine (NEJM) has admitted to leaking a copy of the paper to GlaxoSmithKline more than 2 weeks before it was published in the NEJM.   According to a report in the Wall Street Journal, Steven Haffner, a physician at the University of Texas Health Science Center at San Antonio, broke NEJM confidentiallity rules when he faxed a copy of a Cleveland Clinic Avandia study to a colleague who worked for the drug maker.  What’s more, Haffner had enjoyed a long-term relationship with Glaxo, which had been paying him substantial speaking and consulting fees since 1999.

The news of the Avandia study leak has one Congressman asking questions. Senator Charles Grassley (R-Iowa), a ranking member of the Senate Finance Committee has written Glaxo, asking for more information on the breach of confidentiality, as well as payments Haffner received from the drug maker. (more…)

Vioxx Plaintiffs in Florida Ask for Settlement Changes

Vioxx plaintiffs in Florida are trying to convince the federal judge overseeing the $4.85 billion Merck Vioxx settlement to let them in on the deal, even though they did not file Vioxx lawsuits by the settlement’s Nov. 7, 2007 deadline. Lawyers for about 300 Vioxx plaintiffs in Florida claim that the lawsuits were not filed by the November deadline because under Florida law, they had until September 2008 to sue Merck for their Vioxx injuries.

According to the Associated Press, the Florida lawyers representing these plaintiffs say they had an agreement to set up an “amicable, working relationship” with the plaintiffs’ steering committee “for the mutual benefit of their clients,” and had submitted a list of clients who had not yet filed suit. However, they said, they weren’t informed that a settlement was close, and therefore could not get their clients’ situation considered. (more…)

Ketek Probe Intensifies, as Panel OKs Subpoenas

Subpoenas have been issued by a congressional subcommittee trying to figure out how the dangerous drug Ketek received Food & Drug Administration (FDA) approval, even thought the agency was aware that some of Ketek’s clinical trials were fradulent.

In October, the FDA sent a Warning Letter to Sanofi-Aventis, outlining various instances of misconduct by doctors involved in the Ketek clinical trial, and criticizing the drug maker for ignoring those issues. But it appears the FDA ignored the fraud as well, because it still approved Ketek in spite of the irregularities found in the clinical trials. (more…)

CPSC Recalls Short-Circuiting Glue Guns

Glue guns that short circuit are the latest Chinese made product to be recalled by the Consumer Products Safety Commission (CPSC). According to the CPSC, the defective mini glue guns sold by Dollar Tree Stores can short circuit, causing fires, and putting users at risk of serious injury.

According to the CPSC, the Dollar Tree glue gun recall involves 253,000 “Crafters Square Hot Melt Mini Glue Guns” manufactured in China and imported by Greenbrier International Inc., of Chesapeake, Va. The defective glue guns dispense hot glue, and are intended as a tool for craft projects. Dollar Tree said it had received reports of seven incidents in which the defective glue guns short circuited. At least two injuries involving electrical shocks and burns have been tied to the faulty glue guns. (more…)

Foxwoods Resort Casino Fire is Second Rooftop Casino Blaze This Week

The roof of another casino hotel erupted in flames yesterday.   The rooftop fire at the Great Cedar Hotel the Foxwoods Resort Casino in Connecticut was the second such blaze since the Monte Carlo Hotel and Casino fire last Friday.  The Foxwoods Resort Casino fire yesterday  afternoon resulted in the evacuation of nearly 300 guests. No one was injured as a result of the rooftop blaze at the Great Cedars Hotel at the Foxwoods Resort Casino, but the hotel is expected to remain so for several days.

The fire at the Great Cedars Hotel at the Foxwoods Resort Casino was reported by a security guard stationed across from the building around noon yesterday. At least 50 firefighters from the tribe and surrounding towns responded to the Foxwoods Resort Casino. The fire at the Great Cedar Hotel at Foxwoods Resort Casino smoldered throughout the afternoon, but by early evening it was extinguished. (more…)

Ketek Subpoenas Could be Coming

A Ketek investigation in the US Congress could take a dramatic turn today if a subcommittee approves subpoenas for several Food & Drug Administration (FDA) officials involved in the defective antibiotic’s approval.Congressman Bart Stupak and John Dingell, both Michigan Democrats, want to know why Ketek was able to be approved even though the FDA found instances of serious fraud in its clinical trials. Doctors participating in those clinical trials were paid $400 by Aventis (now part of Sanofi-Aventis) for every patient they convinced to participate in the Ketek study.

This afternoon, the House Energy and Commerce Committee Subcommittee on Oversight and Investigation, headed up by Dingell and Stupak, is scheduled to vote on whether or not to subpoena several FDA officials who investigated Ketek trials. The subpoenas are needed to compel the testimony of Ann Marie Cisneros, a clinical researcher who found fraudulent data in a Ketek study, two current FDA investigators, Robert West and Douglas Loveland, and one former investigator, Robert Ekey. (more…)

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