In addition to other suggestions, U.S. health advisers recommended yesterday that the maximum dose of over-the-counter (OTC) acetaminophen, be lowered.

Exceeding recommended acetaminophen dosages could increase risks for severe liver damage. In 1977, the U.S. Food & Drug Administration (FDA)—which has long been struggling with OTC acetaminophen use and overuse—wanted labels issued to indicate the potential liver damage that can occur when acetaminophen is not used correctly, explained Dow Jones previously. According to a prior FDA statement, safety data reported in medical literature indicates that people sometimes take more acetaminophen than labeling recommends. Others unknowingly take multiple products containing acetaminophen concurrently. (more…)

Lantus, a synthetic form of insulin, is the subject of an Early Communication from the Food & Drug Administration (FDA). According to the agency, it has learned of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus.

Similar to human insulin, Lantus is used to control blood sugar in people with Type 1 and Type 2 diabetes. Lantus, however, is a modified version of human insulin (an insulin analogue) that allows for the control of blood sugar for extended periods of time (a long-acting insulin). Lantus is approved for once-a-day dosage by subcutaneous injection (injection under the skin). (more…)

Fireworks injuries dropped in 2008, but the Consumer Products Safety Commission (CPSC) is reminding consumers to put safety first during the Fourth of July holiday and celebrate with caution this year when it comes to fireworks.

According to the CPSC, there were reports of seven fireworks-related deaths and an estimated 7,000 hospital emergency room treated injuries in 2008. In 2007, the CPSC had reports of eleven deaths and an estimated 9,800 injuries. However, even with fewer reported deaths and injuries in 2008, the one-month period surrounding the Fourth of July is still the most dangerous time. In fact, according to the CPSC, 70 percent of all fireworks-related injuries occurred between June 20 and July 20.

“CPSC wants to keep reducing fireworks-related deaths and injuries in 2009,” said Chairman Inez Tenenbaum. “Children should never play with or light fireworks, and adults should watch our demonstrations to see how powerful and dangerous illegal fireworks can be.”

The CPSC encourages consumers who decide to purchase legal fireworks to:

Never allow young children to play with or ignite fireworks.

Make sure fireworks are legal in your area before buying or using them.

Avoid buying fireworks that come in brown paper packaging, as this can often be a sign that the fireworks were made for professional displays and could pose a danger to consumers.

Adults should always supervise fireworks activities. Parents often don’t realize that there are many injuries from sparklers to children under five. Sparklers burn at temperatures of about 2,000 degrees - hot enough to melt some metals.

Never have any portion of your body directly over a fireworks device when lighting the fuse. Move back a safe distance immediately after lighting.

Never try to re-light or pick up fireworks that have not fully functioned.

Never point or throw fireworks at another person.

Keep a bucket of water or a garden hose handy in case of fire or other mishap.

Light one item at a time, then move back quickly.

Never carry fireworks in a pocket or shoot them off in metal or glass containers.

After fireworks fully complete their functioning, douse the spent device with plenty of water from a bucket.

As a part of its fireworks enforcement program, CPSC actively works with the Bureau of Alcohol, Tobacco and Fire Arms (ATF) to investigate roadside stands, warehouses and retail stores that sell professional grade explosives to consumers, and homes that serve as havens for the manufacture of dangerous fireworks devices. These investigations have resulted in dozens of successful prosecutions by the Justice Department’s Office of Consumer Litigation and U.S. Attorney offices across the country.

On June 19, 2009, a federal judge in the Eastern District of New York sentenced Jon Cea and Vincent Cea to 24 months and 36 months in federal prison, respectively, after they pleaded guilty to conspiracy to engage in the business of dealing in explosive materials, involving the illegal sale of more than 1,000 pounds of explosives. The defendants and their customers were not licensed, yet they purchased and sold professional display fireworks. CPSC and the Justice Department worked in partnership on this case.

Salmonella concerns have prompted Traditions of Pearl, Mississippi to recall an undetermined amount of various boxed pre-packaged meal kits. According to the U.S. Department of Agriculture (USDA), the recalled boxes contain separate portions of instant nonfat dried milk, which was previously recalled.

Those nonfat, dried milk products were originally recalled by Plainview Milk Products Cooperative, Plainview, Minnesota. In addition to the nonfat dried milk products, the company also recalled whey protein, fruit stabilizers, and gums (thickening agents) that it has manufactured over the past two year because of potential Salmonella contamination. The company sells these products to other industry customers, including distributors and manufacturers, who may have incorporated them into their own products. (more…)

BMP protein, a bone growth agent used in products like Medtronic Inc.’s Infuse Bone Graft, may be responsible for serious complications when used to treat neck pain, and may not be cost effective, according to a new study. The study, conducted by researchers at Brigham and Women’s Hospital in Boston, found that when used in the neck region of the spine, some complications from BMP products like Infuse could be life-threatening.

BMP products have become very popular since they were first introduced. According to the Associated Press, some small studies have shown that these products allow better healing of the bone and fewer repeat surgeries to fix failed spinal fusions. The product also makes it unnecessary to surgically harvest the patient’s own bone from the shin or hip for a graft. (more…)

Pms-Phenobarbital tablets have been recalled in Canada because of an overdose risk. According to Health Canada, the pms-Phenobarbital tablets may be oversized, and could contain too much Phenobarbital. The Canadian distributor, Pharmascience Inc. of Montreal Quebec, has initiated a recall of all lots presently on the market.

Phenobarbital is widely used as an anticonvulsant for the treatment of seizure disorders, and it is also used to treat anxiety and sleep related disorders as it has sedative and hypnotic properties. (more…)

Lantus, the blockbuster diabetes drug made by Sanofi-Aventis, may increase the risk of cancer in some patients. The possible link, seen in some new European Lantus studies, prompted the European Association for the Study of Diabetes to call for more studies on the drug.

Lantus is an insulin analogue - an artificial form of insulin. Lantus is an important drug for Aventis, with sales up 28% last year, to $3.43 million, Reuters said. (more…)

Drug companies may be using employees known as medical science liaisons (MSLs) to get around rules that prohibit the promotion of unapproved drug uses, The Wall Street Journal reported today. Because MSLs are considered medical - not sales staff - they are allowed to discuss off-label uses of medications with doctors and other health professionals.

According to the Journal, MSLs are often doctors or pharmacists. They call on doctors to discuss the science behind a medicine, including unapproved uses. (more…)

OKK Trading of Commerce, California, has agreed to pay a $665,000 civil penalty for failing to comply with a 30-year old ban on lead paint on toys, as well as violating other federal child safety standards, the U.S. Consumer Product Safety Commission (CPSC) announced.

The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that from November 2007 through August 2008, OKK Trading knowingly imported and sold toys with paints that contained lead levels that exceeded legal limits. In 1978, a federal ban was put in place that prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. Lead can be toxic if ingested by young children and can cause adverse health consequences. (more…)

Distributor DEWALT Industrial Tool Company, of Towson, Maryland has voluntarily recalled about 9,000 DEWALT D51825 and D51850 Framing Nailers, the U.S. Consumer Product Safety Commission (CPSC) just announced.

The DEWALT Nailers have been recalled because the bump action trigger on the framing nailers could have been incorrectly assembled during production, which would allow the nailer to eject a fastener unexpectedly or cause the trigger lock-off not to function. This potential assembling error can pose a serious injury hazard to the user or bystander. To date, no injuries or incidents have been reported. (more…)