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.

A widely used chemical compound has officially added as a “chemical of concern,” federal regulators said Monday. The chemical, Bisphenol A or BPA, has drawn increased scrutiny in recent years after being linked to health problems ranging from heart disease to abnormal development in animals. The announcement by the Environmental Protection Agency does not existing regulation of the chemical, according to the Washington Post.

Newly released research suggests that the rising cost of cancer treatments may cause some patients to turn down the care they need. According to the analysis, published in the Journal of the American Medical Association, from 1990 to 2008, cancer care costs increased from $27 billion to $90 billion as new drugs were created and less invasive procedures discovered. Researchers agree that a great deal of the cost increase can be traced to financial incentives to doctors who prescribe more expensive drugs. Due to rising costs and increasing number of eligible patients, charities such as the American Cancer Society are able to help less people. In the past, the ACS could help one in five people with the medical bills. Today, they can only help one in six.

Two recently released studies have found that a popular drug to fights osteoporosis may increase the risk of bones breaking if taken for more than five years. Doctors say that the bisphosphonates drugs initially work well to halt bone deterioration, but for some reason begin to have the opposite effect after a number of years. The largest occurrence of the drugâ??s failure happens in post-menopausal women, USA Today reported. The FDA is analyzing the affects of the drugs, but doctors say that much more research is needed to find the cause.

A newly released study has found that three aggressive treatments to prevent heart attacks among Type 2 diabetics could be more harmful than helpful to patients. Doctors have been trying three strategies to reduce the risk of heart attack for diabetics: getting blood pressure to a normal range; raising levels of good cholesterol and lowering levels of dangerous triglycerides; or modulating sharp upswings in blood sugar after a meal. Unfortunately, it has been found that each of those strategies either put patients at more risk of heart attack, or caused severe unwanted side effects without alleviating the heart problems. Doctors across the country expressed disappointment over the results of the study.

Environmental advocates filed a lawsuit in San Francisco Tuesday against five companies who make fish oil supplements, along with retail stores that sell them, claiming the supplements contain levels of polychlorinated biphenyl compounds at levels above what has been deemed safe by health regulators. According to the lawsuit, tests done on fish oil products found levels of PBCs that exceed the California daily limit by a factor of 10 in terms of cancer risk. PCBs were banned by Congress in 1979 as they were know to cause cancer and birth defects. The lawsuit is asking for a label to be put on the products warning consumers of the risks.