Drug Safety

Pharmapack North America: Protect Today’s New Drugs against Contamination

Today’s pharmaceuticals are increasingly being delivered via novel routes, and many are designed for patients to use when treating themselves. “Drug products are undergoing design revisions, giving changing patient populations user-friendly options,” explains Don Singer, Global Lead Quality Manager, Microbiology R&D, GlaxoSmithKline. “It is not just pills and tablets any more. We are seeing many inhalable and intranasal products, and parenterals are no longer just delivered directly by standard syringes and from vials, especially in the oncology field.

FDA Warns Against Use of Diarrhea Treatment

The agency has issued a safety alert on Intestinomicina, a drug product for treatment of infectious diarrhea.

 The U.S. Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a health care provider. Intestinominica contains the prescription drug ingredient, chloramphenicol. Oral forms of chloramphenicol were formally withdrawn from the United States market in July 2012 due to the risk of serious and life threatening injuries.

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FDA Issues Safety Alert on Reumofan Plus

The agency is warning consumers about supplements marketed as natural treatments for muscle pain, osteoporosis and other conditions.

The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.

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FDA Drug Warnings Can Negatively Impact Patient Adherence

Research backed by CVS Caremark suggests only a small number of patients who stop therapy after a warning switch to another treatment option.

New research sponsored by CVS Caremark examined the effects of Food and Drug Administration (FDA) drug warnings on medication adherence when the warnings are not delivered with clear clinical recommendations. The research found that immediately following a high-profile FDA communication questioning the efficacy for a cholesterol-lowering drug, the monthly level of patients who stopped filling their prescription increased by nearly 6 percent.

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American Regent Recalls Cyanocobalamin Vials

The injectable treatment, prescribed for patients with B12 deficiencies, is being recalled due to cracks discovered in certain vials.

American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product:

Cyanocobalamin Injection, USP, 100 mcg/mL, 1 mL Vial NDC # 0517-0031-25Lot # 1662, Exp Date: November, 2013Lot # 1679, Exp Date: November, 2013
Lot # 1683, Exp Date: November, 2013

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NACDS Applauds Rejection of California State Legislation

The National Association of Chain Drug Stores (NACDS) has released a statement "applauding" the rejection of California legislation that would have required a prescription for over-the-counter products containing pseudoephedrine, an ingredient in cold and allergy medications.

Odor Prompts Tylenol Recall

McNeil Consumer Healthcare is recalling one product lot of Tylenol 8-Hour caplets 50 count bottles to the retail level. McNeil is taking this action following a small number of complaints of a musty or moldy odor. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
 

Labeling Change Warns About Possible Long-Term Osteoporosis Drug Risk

The U.S. Food and Drug Administration warns patients and healthcare providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.

Meet the Press: CPGs Map the Future

A panel of respected professionals from leading consumer packaged goods companies will face the industry press at Pack Expo International 2010 to offer their opinions on the latest developments in packaging.

Avandia Concerns Widen Woes For GlaxoSmithKline

FDA is reviewing data from a long-term study concerning possible cardiovascular risks with the drug Avandia, following a recent report from the U.S. Senate Finance Committee that showed a link between the type 2 diabetes drug and thousands of heart attacks. Avandia is manufactured by GlaxoSmithKline, which is also undergoing scrutiny related to the safety of its asthma drug Advair.

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