FDA: MedWatch is the online Safety Information and Adverse Reporting Program of the U.S. Food and Drug Administration (FDA) where you can get timely safety information on drugs and other medical products regulated by the FDA as well as recalls and safety alerts. Sign up to receive alerts by email at www.fda.gov/medwatch/index.html. For a quick view of FDA recalls, alerts and warnings you can also visit Health A to Z atwww.healthatoz.com/healthatoz/Atoz/drugdb/drugGuideRecallList.jsp
OPIOIDS: Some of the most effective pain relievers available are opioids. To get an overview of what exactly opioid medications are as well as their side effects and the risk of addiction to them, go to http://pain-topics.org/patient_resources/index2.php#opioidaware(Source: www.Co-Cure.org, 3/4/09)
RECALL ON SINGLE LOT OF KLONOPIN WAFERS: Hoffman La Roche has announced a recall of a single lot of Klonopin 2 mg Wafers (clonazepam orally disintegrating wafers). The identification number is: NDC 0004-0283, lot # U5011, expiration date March 2010. The recall was necessary because the medication may contain a lower dose of medication than labeled. For more information, please go to: www.fda.gov/bbs/topics/ENFORCE/2009/ENF01105.html.
DIABETES DRUGS ASSOCIATED WITH INCREASED FRACTURES: According to a recent analysis of several large clinical trials, long-term use of the diabetes drugs Avandia (Rosiglitazone) and Actos (Pioglitazone) are found to reduce bone density in the spine and hips of elderly women and increase their risk of fractures. However, this does not apply to men. Because diabetic women already have a higher than normal risk of fractures, doubling the risk by using these drugs could have a substantial effect on them. Women older than 70 who use these drugs are found to have at least one additional fracture among every 21 women. The same drugs were also found to produce an additional fracture for every 55 women who were between the ages of 55 and 70. (Source: Rheumatology Morning Wire from a L.A. Times article by Thomas H. Maugh, 12/13/08)
WARNING ON TENDON INJURIES WITH FLUOROQUINOLONE ANTIBIOTICS: Last October the FDA asked that a boxed warning be added to prescribing information for systemic antibiotics which are known as fluoroquinolones. Fluoroquinolones include the antibiotics Levaquin, Cipro, Factive, Noroxin, Floxin, Proquin and Avelox. The warning is issued to remind healthcare professionals that patients on any one of these drugs are at an increased risk of tendinitis and tendon rupture. The Achilles heel is the most commonly affected but other tendons including rotator cuff, the hand and thumb and the biceps can also be involved. The risk is also increased in individuals over age 60. Also important to note is that the risk for these types of injury can occur months after the drug is stopped. Fluoroquinolones have been known to be associated with serious risks other than tendinitis and tendon rupture. While rare, they but may include convulsions, hallucinations, depression, heart rhythm changes, and serious allergic reactions. For additional information, go to www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone
GARDASIL CERVICAL CANCER VACCINE UNDER SUSPICION: A growing group of parents are wondering if the vaccine given to their daughters to protect them against the sexually transmitted human papillomavirus, known as HPV, is to blame for sudden flu-like symptoms and/or unexplained weight loss, profound fatigue, numbness, tingling in legs, joint pain, breathing problems, and even seizures. Drug manufacturer Merck as well as federal officials insist Gardasil is safe. Read more of the article by (Ohio) Beacon Journal medical writer Cheryl Powell, at: http://www.ohio.com/news/40948777.html
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]
PAIN PATCHES: The FDA has issued a warning regarding certain transdermal patches—these are medicated patches applied directly to the skin—which contain aluminum or other metals in the backing of the patches that can become overheated during an MRI scan and as a result cause skin burns in the immediate area of the patch. The FDA is currently reviewing the labeling and composition of all medicated patches to be certain those which are made with materials containing metal provide a risk of burns warning to patients who wear a patch during an MRI scan. You can read the MedWatch safety summary, including a link to the FDA Public Health Advisory, at: www.fda.gov/medwatch/safety/2009/safety09.htm#Transdermal
BEWARE SINGULAIR: (April 2008) The U.S. Food and Drug Administration (FD) has issued an early warning about the use of Singulair, a leukotriene receptor antagonist used to treat asthma and allergic rhinitis and to prevent asthma which is triggered by exercise. The medication is being linked to behavior and mood changes, suicidal thoughts and behavior, and suicide. Patients should speak to their doctors before they stop taking Singulair and/or if they have any questions about this information. Because of the complexity of the analyses, the FDA may take some time to complete their ongoing evaluation and will announce their findings once this more thorough review is complete.
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
