American Regent is recalling more Ketorolac Tromethamine Injection. The company is now expanding its recall of the injectable painkiller to include all lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials; NDC# 0517-0601-25.

According to the Food & Drug Administration (FDA), this recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. The recalled drug product was distributed to wholesalers and distributors nationwide. (more…)

Bodybuilding.com has issued a nationwide recall for 65 dietary supplement products. All of the recalled supplements were sold through the Bodybuilding.com Web site. According to a notice on the Food & Drug Administration (FDA) website, the agency believes the recalled products contain ingredients that are steroids.

A list of the recalled dietary supplements can be accessed here. The recall includes all lots and expiration dates of the dietary supplement products listed. (more…)

Children’s and Infants’ Tylenol liquid medicines have been recalled because of possible bacterial contamination. The recall involves more than 20 Children’s and Infants’ Tylenol liquid varieties.

According to a “Dear Healthcare Professional” letter issued by McNeil Consumer Healthcare, the bacteria Burkholderia cepacia (B. cepacia) was detected in an “inactive ingredient” in products manufactured between April and June 2008. While ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection, infection has been reported following the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequence of B. cepacia infections could be potentially severe especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or compromised immune systems. (more…)

The U.S. Consumer Product Safety Commission (CPSC), in an effort to create a permanent oversees presence, is planning on opening an office in Beijing. The office is being set up, in part, reported HeraldTribune.com to better work with both Chinese regulators and companies in China and ensure exports coming into the United States from China are safe, according to agency chairwoman Inez Tenenbaum.

The move follows an unprecedented number of recalls that have involved consumer products, children’s toys, pet food, fish, dairy products, and toothpaste, to name just some, noted HeraldTribune.com. Compounding the issue, in recent months toxic Chinese drywall has been causing illness and raising alarm with residents nationwide. (more…)

Arthritis and other autoimmune medications have made recent headlines over a variety of issues including links to serious opportunistic fungal infections and cancer. Now, as part of President Barack Obama’s health care overhaul, a review of arthritis medications manufactured by Wyeth, Abbott Laboratories, and Johnson & Johnson (J&J) might warrant some additional scrutiny, reports Bloomberg.com.

Recently, we reported that federal regulators ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The U.S. Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of its Amendments Act of 2007. (more…)

Zicam maker Matrixx Initiatives Inc. said that it has received an informal inquiry from the Securities Exchange Commission (SEC) over last week’s Food & Drug Administration (FDA) warning on several Zicam nasal cold remedies. Matrixx shares plummeted a whopping 70% the day of the FDA warning.

Last week, the FDA said it had received 130 reports of anosmia – loss of sense of smell – in people who had used three Zicam nasal remedies. Following the FDA alert, Matrixx Initiatives recalled two of the products – Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA. (more…)

Some statins —drugs that lower blood cholesterol levels—have been linked to various adverse events. Now, an emerging study has found that the medications might be negatively affecting patients with Multiple Sclerosis (MS), reports Science Daily, especially in those patients taking high daily doses of statins.

MS is an autoimmune disease of the central nervous system (CNS) and involves the immune cells attacking the nerve fibers’ protective insulation, known as the myelin sheath, as well as myelin-producing cells of the CNS, called oligodendrocytes, explained Science Daily. These activities cause demyelination, which results in damage that hinders “the nerve cell’s ability to transmit signals throughout the nervous system,” Science Daily added.

Researchers looked at the effects of statins on myelin repair in mice and found that statins inhibit remyelination (myelin repair) in the central nervous system, said Science Daily. The study was conducted at the Montreal Neurological Institute (MNI), McGill University; the findings were published in The American Journal of Pathology. The study looked at how simvastatin—a statin in clinical trials—affected myelin in the brain and also looked at the remyelination process, said Science Daily.

The researchers discovered that “simvastatin has in fact, a slightly deleterious effect on myelin,” said Dr. Miron, quoted Science Daily. Dr. Veronique Miron is a post-doctoral fellow at the MNI and is a lead investigator in the study. Dr. Miron explained that during remyelination, myelin and oligodendrocyte production decreases with simvastatin, which means that simvastatin hampers CNS remyelination. This is of note because, in early MS, when an immune system attack on myelin occurs, the oligodendrocyte progenitor cells or stem cells in the CNS work to repair the damage, said Science Daily. If the myelin damage is not reversed, the degeneration continues and worsens.

Other statins have also been in the news for some time over various side effects. For instance, Baycol (generic: cerivastatin) was approved in the United States in 1997, but was pulled from the market in August 2001 because it was linked to Rhabdomyolysis, which caused 31 deaths in the United States. Rhabdomyolysis is a condition that causes muscle-cell breakdown (atrophy) and leads to muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting and is also known to be life threatening. Rhabdomyolysis also injures the kidneys because of the toxic effects of the contents of muscle cells. Myoglobin is an iron-containing pigment found in the skeletal muscle. When the skeletal muscle is damaged, myoglobin is released into the bloodstream and is filtered out by the kidneys. Myoglobin may occlude the structures of the kidney, causing damage such as acute tubular necrosis or kidney failure. Myoglobin breaks down into potentially toxic compounds, which also cause kidney failure.

Crestor, another statin, has also been linked to kidney damage, kidney failure, and Rhabdomyolysis. On October 22, 2004, the consumer group Public Citizen said 29 patients who took AstraZeneca’s cholesterol drug Crestor developed kidney damage and also noted that the rate of reported kidney problems is approximately 75 times higher with Crestor than with all other drugs in the same class combined. The FDA approved Crestor in August 2003 following a delay over safety concerns.

More than 30 dietary supplement products sold by Universal ABC Beauty Supply International, Inc. of Brooklyn, NY are being recalled because they contain Sibutramine, an undeclared drug ingredient. Sibutramine is approved by the Food & Drug Administration (FDA) as an appetite suppressant for weight loss. The FDA has not approved these dietary supplements, therefore the safety and effectiveness of these recalled products is unknown.

The ABC Beauty Supply dietary supplement recall includes the following products: (more…)

Raptiva, an injectable drug used to treat moderate to severe plaque psoriasis, is being withdrawn from the U.S. market. According to Genentech, Raptiva has been associated with progressive multifocal leukoencephalopathy (PML), a serious and almost always fatal brain infection caused by a virus.

Raptiva was approved by the U.S. Food & Drug Administration (FDA) in 2003. Raptiva works by blocking the activation of certain immune cells called T cells, and the migration of those cells into the skin. However, by suppressing the body’s natural defense system, it can also increase the risk of serious infections and malignancies in patients. (more…)

Amid lawsuits and ongoing recalls, KV Pharmaceutical is recalling most of its drugs, said the St. Louis Business Journal.  Yesterday—with the exception of some of the products it distributes, but does not manufacture—KV suspended manufacturing and shipping of all of its products.  KV is also conducting a voluntary recall of most of its products, said the St. Louis Business Journal.

KV said it is likely these moves will have a significant and an adverse effect on its financial profile, which might place it an out-of-compliance status with a number of aspects of its credit agreements, said the St. Louis Journal.  The moves will also “wipe out” most of KV’s market value, Reuters said.  KV’s line of credit totaled around $30 million at year-end, 2008, said the St. Louis Business Journal. (more…)