| Safety, Warnings, & Product Recalls |
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Bausch & Lomb - ReNu brand contact lens solutionReuters - April 10, 2006 PredForteIs your intraocular pressure being monitored on the Pred Forte? Patients who are on this drug for more than 10 days require ongoing IOP monitoring because of the very real risk of inducing glaucoma. Tonometry is known to give falsely low IOP readings after LASIK, so other measures to assess glaucoma (like GDx optic nerve fiber analysis) appear indicated. Have you noticed any visual field losses?. Are your visual fields even being assesed? Check out this info on ophthalmic PredForte http://www.drugs.com/PDR/Pred_Forte_Ophthalmic_Suspension.html Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored. Warnings: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored. By taking this medicine for 6.5 months you are putting yourself at an increased risk for irreversible blindness due to glaucoma. Has your doctor told you this? You need to pin your doctor down regarding what he/she is treating. If not DLK, then what non infectious situation does he/she think he/she is treating. Treating an infectious keratitis with steroids will only worsen the condition. Also long term topical opthalmic steroids are known to thin the cornea and can lead to corneal perforation. Also noted here:EyeWorld February 2006 Quote: The potential intraocular side effects of ocular steroids are well known and include a rise in IOP and the formation of cataracts. SOURCE
Advanced Medical Optics Complete MoisturePLUS Multipurpose Contact Lens Solution
Audience:
Consumers, ophthalmologists, opticians, other healthcare professionals
Alcon Refractive Horizons LADAR6000 Excimer Laser System
Audience:
Ophthalmologists, patients
Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens SolutionMay 26, 2007
The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.
The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).
Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container. "We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."
Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses. Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.
It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm.
"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."
All contact lens users should closely adhere to the following measures to help prevent eye infections: Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming. Wash hands with soap and water and dry them before handling contact lenses. Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional. Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution. Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant. Schedule regular eye exams with your eye care professional Wear and replace contact lenses according to the schedule prescribed by your eye care professional. Store lenses in a proper storage case. Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use. Replace storage cases at least once every three months.
FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.
Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.
Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.
AMO Announces Voluntary Recall of Complete® Moistureplus Multipurpose Solution
Contact:
FOR IMMEDIATE RELEASE -- (SANTA ANA, CA), May 25, 2007 In response to information received today from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections, Advanced Medical Optics is immediately and voluntarily recalling its Complete® MoisturePlusTM contact lens solutions. CDC data was made available to AMO today showing that it had completed interviews with 46 patients who had developed Acanthamoeba keratitis (AK) since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlusTM products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePLUSTM solution versus those who did not. While AMO continues to work with the CDC and the U.S. Food and Drug Administration (FDA) to further assess the data, it is acting with an abundance of caution to voluntarily recall Complete® MoisturePlusTM from the market. There is no evidence to suggest that todays voluntary recall is related to a product contamination issue and this does not impact any of AMOs other contact lens care products, including our family of hydrogen peroxide disinfecting solutions. As patient safety is paramount to AMO, the company is taking decisive action to stop shipments, recall product from the marketplace, and encourage consumers to discontinue the use of AMO Complete® MoisturePlusTM until further information is available. Given the potential seriousness of the reported Acanthamoeba infections, AMO is working in close partnership with the CDC, the FDA and others to make sure consumers are aware of the need for proper contact lens disinfection and proper lens handling.
Acanthamoeba is a microorganism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning (HVAC) systems. Acanthamoeba keratitis (AK) is a rare, but serious, infection of the cornea. AK is usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma. The incidence of AK in the United States has been estimated by CDC at approximately one to two cases per million contact lens users.
Contact lens wearers should consult with their eye doctor if they have any of the following symptoms: eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, and excessive tearing. The symptoms, which can last several weeks to months, are not the same for everybody. Early in the infection, the symptoms of AK can be very similar to the symptoms of other more common eye infections but AK may eventually cause severe pain and possible vision loss with some patients requiring a corneal transplant if untreated.
Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-888-899-9183. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-888-899-9183 for more information.
Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-calling 1-800-347-5005 and to the FDAs MedWatch Program by phone at 1-800-FDA- 1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
Bausch & Lomb Initiates Limited Voluntary Recall of Twelve Lots of ReNu MultiPlus Solutions Due to Potential for Shortened Shelf Life
Contact:
FOR IMMEDIATE RELEASE -- Rochester, New York -- March 6, 2007 -- Bausch & Lomb (NYSE/BOL) has initiated a limited voluntary recall from distribution centers and retail shelves in the United States and specific other countries of 12 lots of ReNu MultiPlus lens care solution made at its plant in Greenville, SC because they contain an elevated level of trace iron. This may result in discoloration of the solution in some bottles, and the shelf life of the product may be shortened to less than its two-year expiration date, due to a potential loss of effectiveness over time. The Company has received no reports of serious adverse events associated with these lots and believes virtually all of the affected product, manufactured about a year ago, has already been used by consumers. Bausch & Lomb has notified the U.S. Food and Drug Administration of this voluntary action. About a million bottles of solution from nine of the 12 lots were originally distributed in the United States. Product from the 12 affected lots was also distributed in Canada, Latin America, Korea and Taiwan, where it is also being recalled.
The company initiated an investigation after receiving three customer reports of discolored solution. The root cause of the discoloration was determined to be an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. Iron is an element present at trace levels measured in parts per billion in many compounds used in manufacturing food, drug, medical device and cosmetic products for human use. The elevated level of trace iron could combine with other compounds in the solution to cause discoloration which signals that the solution may be losing effectiveness over time.
"We have always maintained that the health and safety of consumers is our top priority," said Angela J. Panzarella, vice president and head of Bausch & Lomb's global vision care business. "With detailed and specific information about the distribution of the affected product, and good information about consumer use patterns, we are highly confident that virtually all of the affected product was used before it began to lose effectiveness. We're now in the process of confirming with distributors and retailers that there is no product still available for sale anywhere."
"We are confident we have identified the source of the problem and we are taking appropriate measures designed to avoid a recurrence," Panzarella said. Bausch & Lomb does not expect the costs associated with this limited recall will have a significant impact on its financial results. If consumers notice that their lens care solution appears to be discolored, they should discard it, as it may be losing effectiveness. The recalled lots all carry the expiration date "2008 03" on the bottle. Consumers who have bottles from the lot numbers listed below should check the Company's web site at www.bausch.com/productrecall or call the consumer affairs line (1-866-259-8255) to arrange for a replacement.
LOT NUMBERS SUBJECT TO RECALL: GC6030 GC6037 GC6038 GC6045 GC6048 GC6052 GC6061 GC6063 GC6072 GC6073 GC6080 GC6085
FDA Notifies Public of Adverse Reactions Linked to Botox Use
FOR IMMEDIATE RELEASE February 8, 2008
Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
In an early communication based on the FDA's ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.
The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.
The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.
The FDA is not advising health care professionals to discontinue prescribing these products.
The agency is currently reviewing safety data from clinical studies submitted by the drugs' manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.
The notification is in keeping with the FDA's commitment to inform the public about its ongoing safety reviews of drugs. The early communication, which includes background information and advice for health care professionals, can be viewed at: http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm
Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B)
Audience: Cosmetic Surgeons, neurologists, other healthcare professionals, consumers
[Posted 02/07/2008] FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals.
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