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FDA bans dozens of generics from entering U.S. for quality

From the November ACP Internist, copyright 2008 by the American College of Physicians

Jessica BertholdBy Jessica Berthold

Recalls, warnings, alerts

A ban on more than 30 generic drugs from entering the U.S. due to deficiencies in the manufacturing process. The drugs are made by Ranbaxy Laboratories in India and include simvastatin, metformin, pravastatin, amoxicillin and clarithromycin. A list of affected drugs is available.

Patients with hepatic impairment who receive erlotinib (Tarceva) should be closely monitored during therapy, as hepatic failure, hepatorenal syndrome and fatalities have been reported in these patients. Providers should also exercise extra caution when using the drug in patients with total bilirubin > 3x upper limit of normal (ULN). Dosing should be interrupted or discontinued if liver function changes are severe, such as doubling of total bilirubin and/or tripling of transaminases when pretreatment values are outside the normal range.

FDA bans dozens of generics from entering U.S. for qualityProviders should use only approved eye wash solutions made by Alcon Laboratories and Akorn, Inc., because unapproved solutions made by other companies have led to eye inflammation, cloudy vision, and permanent loss of visual acuity. Providers should also avoid topical creams containing papain because they can cause hypersensitivity reactions that lead to hypotension and tachycardia.

Revised prescribing information for rituximab (Rituxan) to reflect a fatal case of progressive multifocal leukoencephalopathy (PML) that developed in a patient with rheumatoid arthritis. The patient received the drug in a long-term safety extension clinical study and died 18 months after taking the last dose of Rituxan. Providers should consider PML in any patient taking rituximab who presents with new onset neurologic symptoms.

An order to strengthen warnings on prescribing information of four tumor necrosis factor-α blockers (TNF blockers) about the risk of developing opportunistic infections. The drugs are adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel) and infliximab (Remicade). Providers aren't consistently recognizing cases of histoplasmosis and other invasive fungal infections in patients who take these drugs, which has led to delays in treatment and sometimes death.

Providers need to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 μm) when preparing a sodium phenylacetate and sodium benzoate (Ammonul 10%/10%) injection, because the drug maker found particulate matter which could compromise the product's safety. Testing has confirmed the filter will remove the particulate.

A recall of 25 mg/vials of Thymoglobulin (generic name: anti-thymocyte globulin [Rabbit]) because lot number C7010C01 failed a periodic stability test based upon appearance of the reconstituted product. Providers and hospitals should return the product to the manufacturer, Genzyme Corporation. A similar recall of three other lots of Thymoglobulin went into effect last April.

A Class I recall of Pacific Consolidated Industries' Mobile Oxygen Storage Tank, manufactured and distributed between January and March 2007, because the pressure gauge may rupture and catch fire from hydraulic fluid in the pressure gauge tubing. Facilities that have the Mobile Oxygen Storage Tank should keep it in quarantine until arrangements are made to ship it back to the manufacturer.

An alert that two new cases of progressive multifocal leukoencephalopathy (PML) have been reported in European patients taking natalizumab (Tysabri) monotherapy for multiple sclerosis (MS) for more than a year. Previous cases were seen only in patients with MS who took natalizumab as part of combination therapy with immunomodulatory agents. Prescribing information will change to reflect the new cases.

Approvals

Oral capsules of palonosetron hydrochloride (ALOXI), which prevents chemotherapy-induced nausea and vomiting when administered one hour before the therapy. The intravenous form of ALOXI has been available in the U.S. since 2003

AlloMap, a non-invasive test that uses gene expression techniques to help determine the risk of organ rejection for heart transplant patients after surgery.

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