PPIs associated with fractures, IV meds pulled


Recalls, warnings

A warning on proton-pump inhibitors about a possible increased risk of fractures of the hip, wrist and spine associated with high doses or long-term use.

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Labeling changes for orlistat (Alli and Xenical) to include information about cases of severe liver injury that have been reported, although rarely. Physicians should weigh the drug's benefits against potential risks and warn patients to stop taking it if they develop signs of liver injury.

A voluntary recall of all lots of HYLENEX recombinant (hyaluronidase human injection) due to observations of particulate matter in a limited number of vials during routine stability testing.

A strengthened warning for tramadol to emphasize the risks of overdosage (which include central nervous system depression, respiratory depression and death) and the risk of suicide for patients who are addiction-prone, or taking tranquilizers or antidepressant drugs.

An expansion of the March recall of Hospira's Propofol Injectable Emulsion 1% and Liposyn (Intravenous Fat Emulsion) products to include additional lots because some of the containers may contain particulate matter.

A voluntary recall of DBP-2800 Battery Packs used in the Lifeline AED and ReviveR AED semi-automatic external defibrillators and shipped prior to June 4, 2007 because the battery may cause the AED to falsely detect an error condition during charging for a shock, then cancel the charge and not provide therapy.

A recall of all lots of four PediaCare children's products (Multi-Symptom Cold, Long Acting Cough, Decongestant, and Allergy and Cold) because a recent FDA inspection found serious problems at the McNeil Consumer Healthcare plant where the medications are manufactured.

A market withdrawal of two lots of GAMMAGARDLIQUID, Immune Globulin Intravenous (Human), as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with these two lots.

A recall of intravenous medications metronidazole, ciprofloxacin and ondansetron, manufactured by Claris Lifesciences and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals names after the FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron.

Approvals

The Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus, previously approved for emergency use, has been cleared for use after the public health emergency declaration expires.

Alglucosidase alfa (Lumizyme) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder. The drug will only be available through a restricted distribution system to ensure that it is used by the correct patient group and will carry a boxed warning on the risk of anaphylaxis, severe allergic reactions, and immune-mediated reactions.

Denosumab (Prolia), an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures, to be dosed once every six months. Approval was based on a trial in which the drug reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis. Serious adverse reactions include hypocalcaemia, serious infections, and dermatologic reactions.

Miscellaneous

The supply of recombinant thyroid-stimulating hormone (Thyrogen), a drug used in the treatment and follow-up diagnosis of thyroid cancer, will be temporarily limited, the FDA announced. Because of manufacturing issues found at the Genzyme facility where the drug is produced, a consent decree now restricts the distribution of Thyrogen. The drug will be limited to patients for whom the FDA considers the drug to be medically necessary and who are at significantly increased risk of side effects or complications from thyroid hormone withdrawal.

The FDA is currently reviewing two clinical trials in which patients with type 2 diabetes taking olmesartan (Benicar) had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. While the review is ongoing, the agency has not concluded that olmesartan increases the risk of death and currently believes that the benefits to patients with high blood pressure continue to outweigh the potential risks. Benicar (olmesartan) is also sold in combination with hydrocholorothiazide as Benicar HCT.