A committee within the F.D.A. has advised the agency to denounce its marketing approval of the popular cancer drug Avastin for treating breast cancer because “new trials showed no apparent benefit from the drug.” The committee found that new trials of the drug, which is combined with the breast cancer drug paclitaxel to treat metastatic breast cancer, actually showed that survival rates decreased slightly for women due to complications from the drugs. If the F.D.A. decides to follow the committee recommendation, it would not affect marketing of the drug for brain, lung, colon and kidney cancer.

One of the nation’s leading brain imaging centers at Columbia University has be temporarily shut down after F.D.A. investigators found that the center “injected mental patients with drugs that contained potentially dangerous impurities.” The Kreitchman PET Center came under fire from the F.D.A. in December 2008 for violating federal regulations, and the agency raided the labs in January 2010 when the center failed to fix its lax quality control and sloppy procedures for formulating drug injections. To perform certain scans, doctors must first inject patients with a radiotracer, but if the tracer contains too many unknown chemicals, the injection may have harmful affects on the body. The F.D.A investigation found that “at least 10 batches of drugs had been released and injected into human subjects with impurities” above federal regulatory levels since 2007.

A voluntary recall of of 82,000 drop-side cribs has been issued by Pottery Barn due to the high risk that a child may become stuck within the frame and suffocate. This is the 12th recall of such cribs and the U.S. Consumer Product Safety Commission reports that 32 children have died since 2000. The CPSC has also proposed a nation-wide ban on the product and may also require stronger mattresses to be installed in all cribs.

A Food and Drug Administration official last week harshly criticized a major clinical trial for the popular diabetes drug Avandia, saying that the drug maker ignored numerous cases of patients suffering heart problems during the trial. The examiner said he found a dozen instances that point to Avandia causing heart attacks and strokes in patients, which seconds the criticism of many of the drug’s critics. A panel will meet next week to decide if a recommendation should be made to the FDA that Avandia be withdrawn from the market.

High levels of the toxic metal cadmium have forced Wal-Mart stores across the country to pull its Miley Cyrus line of children’s jewelry from the shelves. The Associated Press reported earlier this week that Wal-Mart received information about the high cadmium levels in February, but continued to sell the product. In April, company officials said they were testing all incoming products, but would not test items already on the shelves because “it would be too difficult.” USA Today is reporting that the retailer finally did pull the jewelry because of the AP report.

Tylenol PM and other widely used acetaminophen pain drugs that include a sleep aid, failed to show any significant benefit in a key study, U.S. health regulators have told drugmakers 15 years after industry submitted the data.

Patients taking the drugs, most commonly sold as Johnson & Johnson’s Tylenol PM and Novartis AG’s Excedrin PM, did not fall asleep significantly faster than those who took only acetaminophen or the sedative, known as diphenhydramine citrate, the FDA said in a letter to the industry earlier this year.

The letter, obtained this week by Reuters, comes amid closer scrutiny of dozens of other Tylenol products for children recalled last Friday after FDA inspection turned up contaminated ingredients and unsanitary conditions.

While the agency’s letter does not raise any safety question with such acetaminophen nighttime drugs, it does call into question data backing up their effectiveness.

It is not immediately clear what impact the agency’s decision could have on the combination products, for which the industry initially sought FDA backing in 1995.
Such nonprescription products are not big moneymakers for the drugmakers, but carry significant brand recognition and are widely used.
While they have been sold on the U.S. market for years, winning the FDA’s formal backing offers companies stronger ground with which to market their products.

Tylenol PM is the top-selling nighttime painkiller, ahead of Excedrin PM and Pfizer’s Advil PM, which combines the same sleep aid with ibuprofen.

Still, the FDA’s 15-year gap comes somewhat as a surprise even at an agency where actions can take years.

A report released last month by the Institute of Medicine has found that the high salt content in supermarket and restaurant foods has reached unsafe levels, and urges government officials and the F.D.A. to step in and regulate. High sodium leads to elevated blood pressure and can result in heart disease, and there is no current limit as to how much companies can put in their products. The report urges the F.D.A. to institute a gradual reduction of the maximum amount of salt that can be used in food preparation. According to research, regulating salt use could prevent up to 100,000 deaths each year.

The Agency for Healthcare Research and Quality recently released a report that shows that doctors are still struggling to cut down on post-operative infections acquired by patients in hospitals. The rates of post-operative bloodstream infections and catheter-associated urinary tract infections both increased by substantial amounts over the last year, the report said. The new health care laws may help subdue this trend, however. Hospitals with high rates of infection will face stiff penalties from the government starting in 2015.

The U.S. Food and Drug Administration announced last week that it was bulking up its approval process for new radiotherapy equipment in an effort to cut back on radiation overdoses. The former process of allowing equipment to be approved by outside, third-party reviewers will be eliminated, and the agency will start more aggressively reviewing the devices. As part of their analysis, the F.D.A. found that many of the device problems “could be mitigated by the incorporation of additional safeguards.”

The F.D.A.’s Tobacco Products Scientific Advisory Committee will take a close look at the issue of menthol flavorings in cigarettes this week. Congress has instructed the F.D.A to issue a report on menthol in cigarettes and take action by 2012. Anti-smoking experts say that menthol masks the harsh taste of cigarettes and thus is a useful tool in marketing to young consumers. They also claim that menthol cigarettes are marketed to African-American smokers, who have the highest rates of smoking-related diseases, the New York Times reports. Committee officials have refused to comment on the possibility the F.D.A. may ban menthol completely.