FDA Drug Alerts and Warnings

The following is a list of recent reports, warnings or recalls put out by MedWatch, The FDA Safety Information and Adverse Event Reporting Program, which serves both healthcare professionals and the medical product-using public.

11/19/2007
Age Intervention Eyelash
FDA informed healthcare professionals and consumers of the seizure of 12,682 applicator tubes of Age Intervention Eyelash, sold and distributed by Jan Marini Skin Research, Inc. of San Jose, California. The product was seized because it may lead to decreased vision in some users. The eyelash product is an unapproved and misbranded drug because it is promoted to increase eyelash growth. Before a new drug product may legally be marketed, it must be shown to be safe and effective, and approved by FDA. FDA considers the product to be an adulterated cosmetic because it contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye). Use of the prescription drug in addition to the eyelash product containing the drug, may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to deceased vision and possibly blindness. Other possible adverse events may include macular edema (swelling of the retina) and uveitis (inflammation in the eye) which may lead to decreased vision.

Dermatologists, estheticians, and consumers who may still have Age Intervention Eyelash should discontinue use and discard any remaining product. Consumers should also consult their healthcare professional if they have experienced any adverse events that they suspect are related to use of the product.
(see FDA Medwatch alert)

10/16/2007
Byetta
FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.
(see FDA Medwatch alert)

9/14/2007
B. Braun Medical Inc. Normal Saline Flush Syringes
B. Braun Medical Inc., issued a recall of Normal Saline Flush Syringes with lot numbers ending in "SFR" due to an increase in customer complaints of particulate matter in the saline. The introduction of particular matter into the blood stream may result in phlebitis and/or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is also a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause sever injury and/or death. To date, B. Braun has received no reports of any patient injury associated with this issue.

Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to the usage of this product.
(see FDA Medwatch alert)

8-21-07
METABOLISM Apple Cider Dietary Supplement Voluntarily Recalled –
Confidence Incorporated announced Tuesday it will be accepting returns of one lot of its Apple Cider Dietary Supplement. The product has been found to contain Sibutramine, which is used most commonly in conjunction with weight loss. As an unapproved dietary supplement, METABOLISM Apple Cider cannot contain drugs that are approved by the FDA, as is Sibutramine. The FDA states the, “safety and effectiveness or this product is unknown.” Both pulse rate and blood pressure increase are concerns raised in using Sibutramine. No incidents have been reported thus far.

8-16-07
FDA MedWatch: Nonprescription Cough and Cold Medicine Use in Children

Public Health Advisory and Announcement of Nonprescription Drugs Advisory Committee Meeting Scheduled on October 18-19, 2007

FDA announced that on October 18 - 19, 2007, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.

Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the "Drug Facts" box on the package label. The Public Health Advisory offers parents and caregivers of children recommendations when using cough and cold products in children.

Read the complete MedWatch 2007 Safety summary, including a link to the FDA Public Health Advisory and Federal Register Meeting Notice regarding this issue at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cough

8-14-07
FDA - MedWatch - Kaletra (lopinavir/ritonavir) Oral Solution - Dear Healthcare Provider Letter Regarding The Proper Dosing For Kaletra Oral Solution

Abbott Laboratories disseminated a Dear Healthcare Provider Letter throughout the world to physicians and pharmacists that prescribe/distribute Kaletra Oral Solution. The letter informed healthcare professionals of an accidental overdose that occurred with a pediatric patient taking Kaletra Oral Solution. The infant received a significantly large dose of Kaletra and subsequently died. Healthcare professionals should pay special attention to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors.

Read the complete MedWatch 2007 safety summary including a link to the Manufacturer's Dear Healthcare Provider Letter and Prescribing Information regarding this issue at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#kaletra

8-9-2007
Prilosec / Nexium - Early Communication
FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec and Nexium. The new safety data was from two small long-term clinical studies in patients with severe GERD. In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their gastroesophageal reflux disease (GERD).

The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.

Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec is also sold over the counter for frequent heartburn.

Read the complete 2007 Safety Summary, including a link to the FDA Early Communication About an Ongoing Safety Review document regarding this issue at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole

 

5-21-2007
Avandia Alert
FDA informed healthcare professionals of a potential safety issue related to Avandia (rosiglitazone). An on-going analysis of safety data for the treatment of type 2 diabetes mellitus using Avandia showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus. The clinical studies reviewed to date vary with respect to their populations, treatment regimens, and length of follow-up. Based on these data, the risk of ischemic cardiovascular events due to Avandia remain unclear. Prescribers should continue to carefully make individualized treatment decisions for patients with diabetes mellitus.
Contact an Attorney | See FDA News

5-02-2007
Colchicine Compounded Injectable Products
ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine 0.5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product for return to the company.
Contact an Attorney | See FDA News

3-30-2007
Zelnorm Alert:
FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.
Read about more about Zelnorm | Contact an Attorney | See FDA News

3-29-07
Permax Alert
FDA notified healthcare professionals and patients that companies that manufacture and distribute pergolide have agreed to withdraw the drug from the market. Pergolide is a dopamine agonist (DA) used with levodopa and carbidopa to manage the signs and symptoms of Parkinson's disease. Results of two new studies showed that some patients with Parkinson's disease treated with pergolide had serious damage to their heart valves when compared to patients who did not receive the drug. These two studies confirm earlier studies that also describe this problem. Patients currently taking pergolide should contact their healthcare professional about alternate treatments and not abruptly stop taking their medication. Healthcare professionals should assess their patient's need for DA therapy. If continued treatment with a DA is needed, another DA should be substituted for pergolide.
Read about more about Permax | Contact an Attorney | See FDA News

3-28-07
Accutane Alert
FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online. Isotretinoin is a drug approved for the treatment of severe acne that does not respond to other forms of treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The new webpage, http://www.fda.gov/buyonline/accutane, will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin.
Read about more about Accutane | Contact an Attorney | See FDA News

 

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