Preston Pharmacy News - April 2011
Removal of Unapproved Products
The FDA has announced that it intends to remove certain unapproved prescription cough, cold, and allergy products from the U.S. market. Such products have not been evaluated by the FDA for safety, quality, and efficacy. In 1938 the Federal Food, Drug, and Cosmetic Act required that the FDA approve new drugs for safety. Then in 1962 the act was amended and required new drugs to be proven effective as well as safe to receive FDA approval. The recent removal is a result of the FDA’s Unapproved Drugs Initiative, a drug safety initiative to remove unapproved drugs from the market. A list of the unapproved products the FDA intends to remove can be found on the FDA’s website.1,2
PPI’s and Hypomagnesemia
Healthcare professionals have been notified by the FDA that proton pump inhibitors (PPI’s) such as Prilosec, Nexium, and Prevacid may cause low magnesium levels if taken for a long period of time, usually longer than one year. The FDA is recommending that providers consider checking serum magnesium levels prior to initiation in patients expected to be on a PPI for a long period of time in addition to patients who are taking medications that may reduce magnesium levels such as diuretics. Providers should consider monitoring magnesium levels periodically in patients taking digoxin because hypomagnesemia can increase the potential for serious side effects.
Potential for Medication Errors
Packages of clonidine patches contain a pouch with the clonidine patch and a pouch containing an optional round white adhesive cover patch. The pouch for the cover patch has a warning that it contains no active drug, however mistakes have still occurred where the optional adhesive cover was applied without a clonidine patch underneath. Once removed from its packaging, the clonidine patch is not labeled that it contains the drug. Additionally, the optional adhesive cover is larger than the clonidine patch making it difficult to determine if there is a clonidine patch underneath. The manufacturer does not recommend writing on the clonidine patch because it may affect delivery of the medication. Instead, they recommend labeling the adhesive cover (if used) with the drug name and strength prior to application to indicate there is a clonidine patch underneath. They also recommend leaving a portion of the clonidine patch uncovered.4
Pradaxa Follow up
Last month’s edition mentioned that Pradaxa tablets expire 30 days after the original bottle is opened. The FDA recently announced that data under review indicate it maintains its potency up to 60 days after bottle opening. Information is being gathered on whether it can be used after 60 days of opening and the manufacturer will update the label once the review is complete. Preston Pharmacy is dispensing Pradaxa in unit dose packages which should be opened at time of use. 5
New Drugs
Edarbi (azilsartan medoxomil) – angiotensin-receptor blocker (ARB) approved for the treatment of hypertension in adults.6
Daliresp (roflumilast) – once daily tablet for the treatment of COPD. Daliresp is NOT a bronchodilator and is not indicated for relief of acute bronchospasm. It is in a class that inhibits the enzyme phosphodiesterase 4 and will be dispensed with a medication guide informing patients of the potential risks of psychiatric adverse effects and unexplained weight loss.7,8
Quote of the Month
“Don’t put off until tomorrow what you can do today, because if you enjoy it today you can do it again tomorrow!” ~James A. Michener
References for April, 2011 Issue
- U.S. Food and Drug Administration. Unapproved cough, cold, allergy products: FDA prompts removal from market. Available at: www.fda.gov. Accessed March 7, 2011.
- American Pharmacists Association. FDA removing unapproved prescription cough, cold products from market. Available at: pharmacist.com. Accessed March 18, 2011.
- U.S. Food and Drug Administration. Proton pump inhibitor drugs (PPIs): drug safety communication – low magnesium levels can be associated with long-term use. Available at: fda.gov. Accessed March 18, 2011.
- Cover applied without the medication patch. ISMP Medication Safety Alert! 2010; 15(22).
- U.S. Food and Drug Administration. FDA drug safety communication: special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules. Available at: fda.gov. Accessed March 31, 2011.
- Edarbi [package insert]. Takeda Pharmaceuticals America, Inc., Deerfield, IL; February 2011. general.takedapharm.com. Accessed March 18, 2011.
- Daliresp Web Site. Available at: daliresp.com. Accessed March 18, 2011.
- Daliresp [package insert]. Forest Pharmaceuticals, Inc., St. Louis, MO; February 2011. frx.com. Accessed March 18, 2011.
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