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ORTHO-McNEIL PHARMACEUTICAL, INC. RECALLS SELECT LOTS OF ULTRAM ER (TRAMADOL HCl) EXTENDED-RELEASE TABLETS, 100 mg
Issue: Ortho-McNeil Pharmaceutical, Inc. is recalling several lots of Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg sold in 30 tablets per bottle and physician samples containing 4 tablets in a blister pack. The lot numbers listed below are being recalled because they failed the manufacturer routine tests that measure the rate the tablet released the active medicine. Tablets in these lot numbers may release the active ingredient at a slightly faster rate than required.
The following lot numbers are being recalled:
Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg, 30 count bottle: Lot numbers P08H006, P08I008, P08I009, P08J012, P08J014, P08K017, P08K019, P09B017, P09B018, 09A006P, 09A007P, 09A008P, 09A013P, and 09A014P
Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg, Physician samples 4 count blister pack: Lot numbers 9AA3276 and 9AA3276P1
Ultram ER contains the active ingredient tramadol and is used to treat pain. Tramadol is also available under different names and formulations. This recall alert only applies to the select lots of Ultram ER Extended-Release Tablets, 100 mg. No other lots, strengths, brands, or formulations of tramadol were involved in this recall.
Issue: Certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used. The lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are: Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers) Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers)
Background: Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhaler used to treat patients with asthma and chronic obstructive pulmonary disease. The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce. However, more stolen product may still be on the market and the FDA continues to aggressively investigate the matter.
Stolen medicine may be harmful because it may have been stored at the wrong temperature or humidity or other improper conditions, may degrade or lose potency, become contaminated, or may have been tampered with or handled improperly while outside of the legitimate supply chain.
Recommendation: Patients who have products with these lot numbers should immediately stop using them, contact GlaxoSmithKline's Customer Response Center at 888-825-5249, and follow up with their physician or pharmacist to obtain a proper replacement.
Pharmacists and wholesalers who find Advair Diskus inhalers bearing these lot numbers should remove them from shelves and contact the FDA's Office of Criminal Investigations (OCI) at 800-551-3989. The agency also is asking for the public's help in reporting any information regarding these inhalers, including suspicious or unsolicited offers for the Advair Diskus lots in question, to OCI or by visiting the OCI website.
Read the MedWatch safety alert, including a link to the FDA News Release, at:
IMPULSE CONTOL DISORDER BEHAVIORS ARE CONCERN WITH PRAMIPEXOLE: Although Parkinson's disease and fibromyalgia have quite different biologic aspects, both can be treated with the dopamine agonist pramipexole. This drug has been associated with compulsive behaviors (i.e., gambling, shopping) in Parkinson's users. Now, research by Seattle rheumatologist Andrew J. Holman suggests that the risk is also real for FM patients who take the drug. To read about Dr. Holman's new study, go to: http://www.springerlink.com/content/c36w7073752372np/ [Source: "Impulse Control Disorder Behaviors Associated With Pramipexole Used To Treat Fibromyalgia." J Gambl Stud. 2009 Feb 25. [Ehub ahead of print] PMID: 19241148]
WHO ALERTS: The World Health Organization (known as “WHO”) issues rapid Drug alerts whenever there is a serious problem with the safety of any medicinal product. “Focal points from different departments within WHO constitute the Alert Committee. On receiving information on a ‘potential’ alert, a rapid, ad hoc meeting of the Alert Committee is arranged to validate the information for its source and authenticity, to check for any causality relationship that might have been established, to assess the extent of distribution of the product, and etc. If the material warrants rapid and worldwide distribution, a Drug alert is composed and mailed to the regulatory authorities and nominated National Information Officers in the Member States.” For a listing of the current alerts, go to www.who.int/medicines/publications/drugalerts/en/index.html
