Drugmaker raided by U.S. marshalls

“At the request of the FDA, U.S. Marshals raided generic drug manufacturer Caraco Pharmaceutical Laboratories, Ltd., shutting down manufacturing and seizing inventory. The action came after FDA inspections found that the drug maker was continuing to fail to meet federal safety and health requirements.

In March 2009, Caraco recalled digoxin, a heart medication that requires exact dosage, after it was discovered that some tablets distributed were thicker or thinner than they were supposed to be. This created a serious risk for consumers, as receiving too much of the drug could cause a potentially life-threatening condition known as digoxin toxicity, and receiving too little of the medication could result in injury from the underlying heart condition.”

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Soda being regulated by FDA?

I saw a link to the Examiner but no article appeared and I haven’t seen another news source report.

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Skin care product recall

“The FDA is warning consumers not to use any Clarcon skin products, including Citrushield, Dermassentials, Skin Shield and Total Skin Care, as they may be contaminated with bacteria that could cause serious skin infections.

The skin care product recall involves over-the-counter topical antimicrobial skin sanitizers and hand protectant products made by Clarcon Biological Chemistry Laboratory, Inc., which have been found to contain “high levels of disease-causing bacteria,” according to the FDA. This could cause infections of the skin or underlying tissue, potentially requiring surgery or resulting in permanent damage.”

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FDA:smoking cure-all may have nasty side effects

“Chantix (varenicline tartrate) is one of 19 drugs or classes of medications identified by the FDA that showed potential signs of safety issues in the Adverse Event Reporting System (AERS) between October 2008 and December 2008.

Side effects of Chantix are being examined for a possible increased risk of angiodema, serious skin reactions, visual impairment and accidental injury. The FDA indicates that they are evaluating these issues to determine whether there is any need for regulatory action, such as stronger warnings.”

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Food safety wishlist for new FDA boss

Read all of them here but these are a couple that I didn’t know weren’t better regulated.

“6. We know you need Congress for this, but isn’t it ridiculous that the FDA can’t mandate a company to stop shipping tainted food? Today, all recalls are voluntary.

7. While we’re at it, ask Capitol Hill to allow prosecution of CEOs and processing plant managers who knowingly continue to ship poisoned products. Nothing like the fear of jail time to get folks thinking straight.

…

9. Lastly – Food safety is divided among too many government bodies, including the FDA, USDA, the Bureau of Alcohol, Tobacco, Firearms and Explosives, and others. At times there is overlap between the regulatory bodies, and sometimes the opposite. Wouldn’t it be smarter to have all food safety issues handles under one roof?”

Arthritis drug has fungal infection side effects

“The FDA issued a MedWatch Alert on Thursday to remind doctors about the potential side effects of Simponi, a recently-approved drug for treatment of arthritis, which can increase the risk of serious fungal infections. Delays in recognizing the infections and starting patients on antifungal treatments could result in potentially life-threatening injuries.”

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Cheerios lower cholesterol? FDA unhappy

“General Mills is in trouble over some health claims it has been making over its popular cereal, Cheerios. The Associated Press (AP) reported that federal regulators are miffed over the cereal giant’s claims that Cheerios can lower cholesterol and treat heart disease, claims, says the U.S. Food and Drug Administration (FDA), that are only allowable on FDA-approved medications.

The AP noted that the cereal’s labeling states, “you can lower your cholesterol four percent in six weeks.” General Mills argued that the claims have been approved for 12 years, said the AP. The San Francisco Gate (SF Gate) pointed out that the problem has to do with how the cereal is marketed on the box with the words “lower cholesterol” larger and separate from “ability to reduce the risk of heart disease.”

Feds says: beware of fake swine flu products

“The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending Web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.

“Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families,” said Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs. “In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

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Dietary supplements need FDA pre-market testing

Pharmaceuticals go through several rounds of clinical testing but non-pharmaceutical medications like Hydrocut, a dietary supplement does not and the results are last weeks huge recall because of serious reports of liver damage.

“Supplements like Hydroxycut and StarCaps are allowed to endanger the public because the FDA has no authority to order premarket testing of such products. In fact, according to the FASEB editorial, since 1994,the FDA has had no effective regulatory authority over dietary supplements, unless they cause harm or are doped with prescription drugs. Thus, as in the case of Hydroxycut, such products can harm dozens of people before they are removed from the market.”

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Lawyers eye on suits against Hydroxycut

Two days after the FDA warning against dietary supplement Hydroxycut, here comes the lawyers:

“A group of lawyers are seeking to sue the manufacturer of Hydroxycut after the FDA issued a warning against use of the popular weight loss supplements.

The FDA issued a statement on May 1 advising consumers to immediately stop using 14 Hydroxycut products, manufactured by Canadian company Iovate Health Sciences Inc., after receiving 23 reports of health problems which include potential liver injury and one death.”

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