A study of patients exposed to gadolinium contrast dyes at the Mayo Clinic has revealed that hemodialysis patients had a 77-fold higher risk of developing nephrogenic systemic fibrosis (NSF), while kidney transplant patients had a 69-fold higher risk of the disease. The NSF study was published in the October issue of the Archives of Dermatology.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. (more…)

The U.S. Food & Drug Administration (FDA) just issued 22 warning letters to Web site operators as part of its International Internet Week of Action (IIWA), a coordinated, weeklong, international effort intended to curb illegal actions involving medical products.

The FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada, the FDA noted. (more…)

Vicks Sinex nasal spray is being recalled in three countries because of potential bacterial contamination. According to a recall notice issued by Proctor & Gamble, the recall includes three lots of Vicks Sinex nasal spray sold in the United States, United Kingdom and Germany. The bacteria, B. cepacia, has been found in a small amount of Vicks Sinex nasal spray from the recalled lot sold in the States, the notice said.

The three lots of Vicks Sinex nasal spray being recalled are:

United States: Lot # 9239028831; Product Name: Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray

United Kingdom: Lot # 9224028832l; Product Name: Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml

Germany: Lot # 9224028833; Product Name: Wick Sinex Schnupfenspray Dosiersystem, 15 ml

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The maker of OptiMARK gadolinium contrast agent is modifying the product’s label to contraindicate its use in patients with severe kidney impairment because of its association with nephrogenic systemic fibrosis (NSF). Mallinckrodt Inc., a Covidien company, has submitted this label change to the U.S. Food and Drug Administration (FDA) and says it is implementing the new label in the U.S. effective immediately.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnostics, Bayer Healthcare’s Magnevist and GE Healthcare’s Omniscan. (more…)

RockHard Laboratories is conducting a voluntary nationwide recall of specific lots of its dietary supplement sold under the name RockHard Weekend (RHW), the U.S. Food & Drug Administration (FDA) just announced.

RockHard Laboratories is conducting the recall after being informed by the FDA that voluntary lab analysis found that RHW, specific to the affected lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This makes RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label. (more…)

Three gadolinium contrast dyes – Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan, and Covidien ’s OptiMARK -carry a higher risk of nephrogenic systemic fibrosis (NSF) than other agents on the market, according to the U.S. Food & Drug Administration (FDA). Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition to Omniscan, Magnevist and OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnotics. (more…)

Gardasil or other HPV vaccination will no longer be a requirement for immigrant girls and women seeking a green card, according to the Associated Press (AP). Currently, the U.S. Centers for Disease Control and Prevention (CDC) requires that all immigrants filing for a green card must receive a variety of shots; the HPV vaccine is currently among those required.

Effective December 14, the HPV vaccination will not be required, said the AP, in an effort to not single out immigrants. The requirement to receive at least the first dose of the HPV vaccine, which is administered in three doses, was implemented by the CDC for female immigrants between the ages of 11 and 26 in July 2008. (more…)

Prilosec and Nexium reduce the anti-clotting effects of Plavix, according to a Public Health Advisory issued by the U.S. Food & Drug Administration (FDA). As a result, patients at risk for heart attacks or strokes who use Plavix to prevent blood clots will not get the full effect of this medicine if they are also taking Prilosec or Nexium. The agency warned yesterday that patients who take Plavix should use different medications to treat acid reflux, such as Mylanta or Zantac.

Prilosec inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said. New studies compared the amount of Plavix’s active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as 47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said. (more…)

News media are reporting that the U.S. Food and Drug Administration (FDA) has issued warning letters to Shire PLC and Eisai Co Ltd about drug promotions for Dacogen and Fosrenol. The warning letters state that the Dacogen (Eisai) and Fosrenol (Shire) promotions understate the risk and overstate the benefits of the medications.

The FDA said that a customer-intended promotional card created by Eisai “presents numerous claims that misleadingly overstate the efficacy” of Dacogen, reported Reuters. Dacogen is a medication used in the treatment of the blood disorders myelodysplastic syndromes. The letter, dated November 6, also stated that Eisai’s campaign “omits material risks associated with Dacogen treatment.” (more…)

The U.S. Food and Drug Administration (FDA) informed GMP Herbal Products, Inc. that its weight loss dietary supplement, sold and marketed as Pai You Guo, contains undeclared ingredients.

An FDA lab analyses of dietary supplements distributed by GMP Herbal Products found them to contain two undeclared ingredients: (more…)