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…)

One infant has died and four other children have fallen ill from a disease that had been all but eradicated, CNN has reported; the baby was just seven months old.  Hib—Haemophilus influenzae type b—is the pathogen responsible for the deaths and illnesses, which have all occurred in Minnesota, CNN added.

The baby and two other children did not receive any vaccinations, according to the U.S. Centers for Disease Control and Prevention (CDC), said CNN.  FiercePharma reported that the other two children had not completed the immunization series.  “The situation is of concern,” said Dr. Anne Schuchat, CDC director of the National Center for Immunization and Respiratory Disease.  “It could be happening elsewhere and, of course, it’s tragic that one of the children actually died from a preventable disease,” quoted CNN. (more…)

The U.S. Food and Drug Administration (FDA) just announced it is adding a Boxed Warning to the prescription oral sodium phosphate (OSP) products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy, which is a type of serious kidney injury.  OSPs are generally taken by patients for bowel cleansing prior to certain medical procedures such as colonoscopy.

The FDA has also mandated that the OSP maker develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of OSPs, and conduct a post-marketing clinical trial to further assess the risk of acute kidney injury with OSP use. (more…)

The U.S. Food and Drug Administration (FDA) has issued two immediately effective recalls involving potentially dangerous nutritional supplements.  Both recalls have been implemented over undeclared, prescription-level ingredients, which classifies them as unapproved drugs.

In the first recall, Balanced Health Products, Inc. is voluntarily recalling Starcaps Dietary Supplement Capsules because they were found to contain an undeclared drug ingredient:  Bumetanide at a level of 0.8 mg per capsule.  The lot number involved is 12/2011–84810 and the supplements were sold in 30-capsule plastic bottles.  The bottles—1,974 in total—were distributed nationwide from August 2008 to October 30, 2008 to retail outlets and via online sales. (more…)

Acne creams sold at Dollar General, Kroger or Wal-Mart have been recalled because of bacterial contamination.  According to the Food & Drug Administration (FDA), the recalled acne creams most likely do not pose a hazard to healthy people, but could be harmful to anyone with a compromised immune system.

All of the acne creams involved in this recall were manufactured by CSI, USA, Inc.  The acne cream recall involves all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: “DG Maximum Strength Acne Medicated Gel” (sold at Dollar General); “Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication” (sold at Kroger); and “Equate: Medicated Acne Gel” (sold at Wal-Mart). No other acne medications sold by Dollar General, Kroger or Wal-Mart are affected by this recall. (more…)

Mylicon Drops, a popular remedy for infant gas, are being recalled because they may contain pieces of metal.  Johnson & Johnson, the maker of Mylicon Drops, said in a press release that the chances for injury is low, but decided to issue the recall as a precaution.

Infants’ Mylicon drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods. (more…)

In its most recent recall, the U.S. Consumer Product Safety Commission (CPSC), in cooperation with Hewlett Packard, today announced a voluntary recall of its HP Fax 1010 and 1010xi machines because an internal electrical component failure can cause overheating of the product, which poses a risk of burn or fire.

About 367,000 units—and an additional 84,000 units sold outside of the U.S.—which were imported by Hewlett-Packard Company of Palo Alto, California, have been recalled.  To date, Hewlett-Packard has received three reports of overheating including two in the U.S. resulting in minor property damage. No injuries have yet been reported. (more…)