Medication Monitor

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  • April 4, 2012

    FDA has alerted the public that lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400 mg/16 mL has been found in the United States. The counterfeit version contains no active ingredient. The agency noted that Altuzan is not approved for use in the United States and is only an approved drug in Turkey. The only FDA-approved version of bevacizumab available in the United States is marketed as Avastin by Genentech, a member company of Roche.

    The counterfeit product was obtained through foreign sources, specifically from Richards Pharma, also known as Richards Services; Warwick Healthcare Solutions; or Ban Dune Marketing Inc. Packaging or vials claiming to be Roche’s Altuzan with lot number B6021 found in the United States should be considered counterfeit.

    FDA noted that any medical practice that has obtained unapproved products from these foreign sources should stop using them and contact the agency immediately. The products should be retained and securely stored until further notice by FDA.

  • October 6, 2014

    Sagent Pharmaceuticals, Inc., issued a voluntary nationwide recall of three lots (lot numbers MP5021, MP5024 and MP5025) of ketorolac tromethamine injection, 30-mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02), manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product.

    The product is a nonsteroidal anti-inflammatory drug indicated for short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting, and is supplied in a single-dose vial.

    The lot numbers being recalled were distributed to hospitals, wholesalers, and distributors nationwide from September 17, 2014, through October 1, 2014.

  • July 21, 2014

    FDA is warning about powdered pure caffeine being marketed directly to consumers and recommends avoiding these products. In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the Internet. It is nearly impossible to measure powdered pure caffeine accurately with common kitchen measuring tools, and a lethal amount can easily be consumed, FDA warned.

    These products are essentially 100% caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee. Very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.

    FDA is aware of at least one death of a teenager who used these products. 

    Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures, and death. Vomiting, diarrhea, stupor, and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea, or other caffeinated beverages.

    FDA advises that those who believe they are having an adverse event related to pure caffeine stop using it and seek immediate medical care or advice.

    Report adverse events associated with powdered pure caffeine and other highly caffeinated products by calling 240-402-2405 or e-mail at

  • July 2, 2014

    Bristol-Myers Squibb has issued a voluntary recall of six lots of warfarin sodium for injection (5-mg single-use vials) in the United States. Visible particulate matter was found in a small number of unreleased samples.

    Injected particulate metallic and nonmetallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur.

    To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue.

    The product is packaged in cartons of six vials and includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: 201125, 201126, 201127, 201228, 201229, 201230.

    Warfarin sodium for injection was discontinued in early April 2014. The oral formulation is not affected by this recall.

  • March 7, 2014

    FDA is warning that doripenem, an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared with use of imipenem and cilastatin for injection (marketed in the United States under the name Primaxin).

    Based on an FDA analysis of data from a 3-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA approved changes to the doripenem drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doripenem is not approved to treat any type of pneumonia.

    In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day doripenem treatment or 10-day treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the doripenem arm than in the imipenem and cilastatin arm. Clinical cure rates were also lower in the doripenem arm.

    Health professionals should consider whether doripenem's benefits are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doripenem is still considered safe and effective for its FDA-approved indications: treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections.