FDA News

Stolen Advair Diskus Inhalers Pose Risk

07/17/2010

The Food and Drug Administration is warning consumers not to use inhalers stolen from a Virginia warehouse after some of the pilfered medicine turned up in some pharmacies.

The stolen Advair Diskus inhalers (fluticasone propionate and salmeterol inhalation powder) were found recently—the first batch known to have hit the supply chain since the August 2009 theft. As the investigation continues, FDA officials warned the public that more of the stolen inhalers could still be on the market.More »

Advair Diskus, FDA, GlaxoSmithKline

FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin

07/11/2010

The U.S. Food and Drug Administration warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

Qualaquin is not FDA-approved to treat or prevent night time leg cramps.More »

FDA Alert

FDA Sounds Alarm on Phony Tamiflu

06/17/2010

The FDA is warning consumers that a phony version of an antiviral drug being sold on the Internet could spark a harmful reaction in some people.

Investigators found the drug was being sold as “generic Tamiflu,” even though FDA has not approved a generic version of Tamiflu, which is used in treatment of the flu.More »

FDA Alert, Tamiflu

FDA Updates Labeling of LABAs in Treating Asthma

06/03/2010

Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma. The new recommendations do not apply to the use of LABAs for the treatment of COPD.

In February 2010, the agency announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma (see February 2010 LABA Drug Safety Communication1).More »

LABAs, Long-acting Beta Agonsists

Four PediaCare Children's Products Recalled

06/01/2010

Blacksmith Brands and FDA notified healthcare professionals and patients about a nationwide recall of all lots of four PediaCare children's products. These products are sold exclusively in the United States and were manufactured by McNeil Consumer Healthcare at McNeil's Fort Washington, PA plant.

The four PediaCare items involved in the recall are:

PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

Blacksmith Brands initiated the recall as a precautionary step because the products were manufactued at a McNeil plant in which a recent FDA inspection found serious problems in meeting FDA's current good manufacturing practice requirements. The company advises consumers who have purchased these recalled products to discontinue use.More »

FDA. PediaCare

Intravenous Medications Recalled Due to Product Contamination

06/01/2010

FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product.

Healthcare professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available. Please review the linked Public Health Alert for a list of the affected and recalled products.More »

Claris, intravenous

FDA Clears First 2009 H1N1 Influenza Virus Test Previously Available Under Emergency Use Authorization

05/24/2010

The U.S. Food and Drug Administration announced it has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection.

Until this clearance, tests for 2009 H1N1 Influenza were only available through an Emergency Use Authorization (EUA), which allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect.More »

H1N1 Flu

No Evidence Linking Cell Phone Use to Risk of Brain Tumors

05/18/2010

Do the radio waves that cell phones emit pose a threat to health?

Although research is ongoing, the Food and Drug Administration (FDA) says that available scientific evidence—including World Health Organization (WHO) findings4 released May 17, 2010—shows no increased health risk due to radiofrequency (RF) energy, a form of electromagnetic radiation that is emitted by cell phones.

FDA also cites a separate National Cancer Institute program finding that, despite the dramatic increase in cell phone use, occurrences of brain cancer did not increase between 1987 and 2005.

FDA shares regulatory responsibilities for cell phones with the Federal Communications Commission.More »

brain tumor, cell phones

Voluntary Recall of Metronidazole Injection 500 mg / 100 ml

05/18/2010

Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL manufactured by Claris Lifesciences and distributed by Sagent due to the discovery of non-sterility in two lots of metronidazole injection. Non-sterility of an antimicrobial administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation.More »

FDA, metronidazole, Sagent

FDA Revises Recommendations for Rotavirus Vaccines

05/14/2010

The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.More »

FDA, rotavirus

1 of 7

Syndicate content