The July 2011 ezine edition of The Health Gazette will be published as scheduled today.
This month we have Part 10 in our series on The Dimensions of Health. Part 10 provides further discussion of mental health.
Why not come and join us? You can catch up on the series in the Subscriber Archive.
Tags: dimensions of health, Health Gazette Ezine, mental health
This warning applies to valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
FDA notified healthcare professionals that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy. See the Drug Safety Communication for a data summary and additional information.
Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.
Healthcare professionals should inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure, and should continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy. In addition, healthcare professionals should weigh the benefits and risks of valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of adverse birth outcomes should be considered. Patients should not stop taking valproate without talking to a healthcare professional.
You should avoid taking any drugs unless you absolutely have to take them. Do not be persuaded that you need drugs on the basis of pharmaceutical company advertising! Do not accept a prescription unless the person prescribing provides you with a clear explanation of why you need it, how it works, what benefits you should notice, all of the known side-effects, what alternatives exist and what will happen if you decline the prescription.
McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recall stems from a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA). While not considered to be toxic, TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.
BACKGROUND: The Tylenol lot ABA619 – which includes 60,912 bottles – was manufactured in February, 2009. The product lot number for the recalled product can be found on the side of the bottle label.
RECOMMENDATION: Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: You can complete and submit the report online here: www.fda.gov/MedWatch/report.htm
Endo Pharmaceuticals and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg because some bottles may contain different strength tablets, resulting in patients taking more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.
The affected lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL and TN. These wholesalers may further distribute to other retailers and wholesalers nationwide. Lot numbers can be found on the side of the manufacturer’s bottle. Tablet descriptions and photographs are provided in the firm’s press release.
RECOMMENDATION: Consumers who have the affected product should stop using the product and contact Endo’s agent Stericycle at 1-866-723-2681 for return of the product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Like ALL pharmaceutical companies Endo Pharmaceuticals sometimes makes errors, at least some of which are discovered and may be reported such as this one. Never consume pharmaceuticals that you do not really need. All pharmaceuticals, regardless of whether or not they actually confer any benefit, do expose consumers to risk of harm. Pharmaceutical companies accept that risk because they are in business to make a profit. Consumers accept that risk for various reasons, few of which are actually valid.
June 24, 2011 – Qualitest Pharmaceuticals today issued a voluntary nationwide retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg. This recall was initiated because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number C0590909B. Lots C0390909A, C0400909A, C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.
Because the recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone (Acetaminophen is in both preparations.) Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction. Side effects due to caffeine are less likely, due to the small amounts in this formulation, however, those individuals with a sensitivity to caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution. No injuries have been reported to date.
The recall includes the following products:
- Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.
These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the manufacturer’s bottle. Butalbital, Acetaminophen, and Caffeine Tablets are (approximately 11.0 mm in diameter), white round-shaped tablets, debossed (2544) on one side, and debossed (V) on the reverse side; Hydrocodone Bitartrate and Acetaminophen Tablets are (approximately 16.5 mm in length), white with green specs, round, capsule shaped, scored tablets, debossed (3594) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Hydrocodone Bitartrate and Acetaninophen manufactured by Qualitest, are asked to double check the identity of their tablets.
Tablet descriptions:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg are supplied as white with green specks, capsule-shaped, scored tablets, debossed “3594” on one side and debossed “V” on the reverse side.
Butalbital, Acetaminophen and Caffeine Tablets, USP
Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed “2355” on one side, and debossed “V” on the reverse side.
Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.
Consumers and patients with questions may contact Qualitest at 1-800-444-4011 for more information. Monday through Friday between the hours of 8AM and 5PM CST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
Reports of adverse reactions or quality problems can also be reported to Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8AM and 5PM CST.
About Qualitest
Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com).
Like ALL pharmaceutical companies Qualitest sometimes makes errors, at least some of which are discovered and may be reported such as this one. Never consume pharmaceuticals that you do not really need. All pharmaceuticals, regardless of whether or not they actually confer any benefit, do expose consumers to risk of harm. Pharmaceutical companies accept that risk because they are in business to make a profit. Consumers accept that risk for various reasons, few of which are actually valid.