Popular Allergy Drug Under FDA Inspection
Singulair is a very popular medication prescribed for allergies; it is used with much success for both typical allergy reactions and in preventing asthma attacks. As such, it is a medication that both physicians and patients have been pleased to have available.
Unfortunately the old saying of when something seems too good to be true, it probably is, may also hold true with Singulair. There is a possible link between Singulair and suicide ideation as well as mood swings, anxiety and depression. Merck, the manufacturer of Singulair, points out that these are reactions received by report only and have not been observed in clinical testing.
”We have no indication that anything about the mechanism of Singulair is consistent with these events,” said George Philip, Director of Research and Product Development, Merck & Co, Inc. ”But because suicide is a life-threatening event we thought it was important to provide this information in the product label.”
Further information can be found at the link below. It is important that patients not discontinue Singulair suddenly without a physician’s guidance. Patients on Singulair who are concerned about these side effects should talk with their medical care provider as soon as possible.
FDA Early Communication Report on Singulair
FDA Investigates Merck Drug - Suicide Link
Recalls - Chicken in Alabama and Empanadas in Southern States
Cagle’s Inc., a Collinsville, Ala., establishment, is voluntarily recalling approximately 943,000 pounds of various fresh and frozen poultry giblets and fresh carcasses with giblets inserted that may be adulterated due to improper disposition of the giblets, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced on March 14th. This is considered a Class I recall (High Health Risk).(FSIS)
Publix Super Markets is issuing a voluntary recall on all codes of prepackaged 2 and 4-pack Apple, Pineapple and Pumpkin Empanadas sold in retail bakeries due to the undeclared milk ingredient. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.(FDA)
“Icy Hot Heat Therapy” Recall
A popular product, “Icy Hot Heat Therapy,” manufactured in patches. The recall was initiated due to burns reported by consumers ranging from first to third degree burns.
All “Icy Hot Heat Therapy” patches were recalled regardless of lot number and size. Products include:
- Icy Hot Heat Therapy Air Activated Heat- Back
- Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg
- Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg single consumer use “samples” included on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Crème.*
*Please note that “Aspercreme” is not affected. Samples of “Icy Hot” were included in “Aspercreme” packaging and only those samples are involved in the recall.
Any of the “Icy Hot” product should be discarded or returned to the manufacturer for a full refund. Product may be returned for a refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-877-742-6275 (M-F from 8am to 4pm EST) or through their website.
This is a voluntary recall by Chattem, Inc., manufacturer of the product.
Olivier brand Parmesan & Asiago Dip with Garlic & Basil
The dip Olivier Parmesan & Asiago With Garlic & Basil has recalled as of this date, February 5th. it has been recalled due to the possibility of contamination with Clostridium botulinum. This product is made by Olivier Olive Oil Products, Inc. of St. Helena, California and has been voluntarily recalled by the manufacturer.
Clostridium botulinum is potentially life threatening illness and as such should be treated seriously.
Further information can be found at the links below. A photo of the product is included to help consumers identify the product in question.
FDA Recall Alert - Olivier Brand Parmesan & Asiago Dip with Garlic & Basil
Recalls You Need To Know About
They say what you don’t know, can’t hurt you. That certainly isn’t true with products that have been recalled. There are hundreds of products recalled every month; some are FDA directed and some are voluntarily recalled by the manufacturer. Some are for reasons that hardly seem worth the time to fuss with a formal recall. Others are pulled off the market for deadly reasons. The lists of recalls are long and sometimes complicated.
At this site you can check frequently to reference in one convenient location the recalls that could affect you and your family. 
Most are listed out and won’t be an issue. Of course it is virtually impossible to keep up with all of the recalls that happen in the United States. But the lists are here for you to reference. What is important is that the recalls that are of an urgent nature will be the top headline in this section and available for quick referencing. Stay in “The Know,” because what you don’t know, can hurt you.
ALERT: Potential Botulism in Canned Green Beans
In Other News:
FDA Recalls, Market Withdrawals and Safety Alerts
Food Safety and Inspection Service Recalls
FDA Center For Drug Evaluation and Research
U.S. Consumer Product Safety Commission Recalls and Product Safety News
FDA Concerned: Suicide Ideation with Seizure Drugs
The FDA has released information that patients taking medications for epilepsy, bipolar depression and some mood disorders, are experiencing an increase in suicidal thoughts. The risks are not insubstantial either; the FDA states that risk is doubled. Physicians however believe that the benefits of these medications outweigh the risks.
- The drugs of concern include:
- Depakote
- Lamictal
- Topamax
- Keppra
- Lyrica
- Neurontin
Interestingly enough, very recently the FDA approved the medication Lyrica for the treatment of fibromyalgia. It does indeed raise the question of what does it mean to have the risks outweigh the benefits.
The FDA will be meeting with various drug companies to discuss warning labels that will be placed on these medications. It is unclear as to what these warnings will say as the risk seems to be greater for the anticonvulsant medications than those used for psychiatric purposes. And the problem is only made more complex when it is realized that all of the medical conditions that these drugs are prescribed for, are difficult to treat. A patient may only have one of two options. Then of course “risk vs benefit” becomes a very personal issue.
“The consequences of seizures are dire,” Dr. Cynthia Harden, a professor of neurology at Weill Cornell Medical College said. “There’s a risk of injury, even brain injury from a prolonged seizure, a loss of awareness and tremendous anxiety as these episodes can come without warning. It’s a very difficult illness to live with, and these drugs are well worth trying.”
The New York Times
Hopefully in time, research can find ways to treat these disorders and simultaneously avoid side effects. The vagus nerve stimulation treatment is one option that is showing very promising results for people with seizure disorders. Cognitive therapy can be helpful for those with mood disorders.
But unfortunately at this time we are left with disorders and medications that produce potentially deadly side effects. Answers do not come easily to such problems.
FDA Alerts Healthcare Providers
FDA Approves Lyrica for Fibromyalgia
New Drug Seeks Approval For Fibromyalgia Treatment
Fibromyalgia is an interesting disease. It is qualified by not being something else, and a person is diagnosed with it by the proof of them not having another disease. It is often not taken seriously because of this and few drugs are FDA approved for the treatment of fibromyalgia. (There are many drugs used to treat the condition, but they are medications approved for other purposes, that for some reason work with fibromyalgia.) The drug that is currently seeking approval is Milnacipran.
Milnacipran is what is known as a “dual reuptake inhibitor,” which makes it similar to SSRI medications such as Prozac and Zoloft but with an enhanced function of working with two transmitters rather than just the one. (Norepinephrine and serotonin) Trials have shown that patients treated with Milnacipran have shown improvement in the classic fibromyalgia symptoms of chronic pain, fatigue, and cognitive dysfunction.
Few medications have been approved for use for fibromyalgia, and incidentally chronic fatigue syndrome, a related condition. Approval could mean hope for relief for millions of Americans as well as increasing awareness and validity to this disease that is very misunderstood.
General History and Information About Milnacipran
Potential Botulism in Canned Green Beans
The FDA is warning consumers that canned green beans manufactured by New Era Canning Company (MI) and distributed under the label of “GFS Fancy Blue Lake Cut Green Beans,” may be found to contain C. botulinum, better known as botulism.
The canned cut green beans were distributed to retailers, restaurants and foodservice institutions by Gordon Food Service, Grand Rapids, Mich., with lot code 19H7FL and UPC code 93901 11873, in large institutional-sized, 6 pound 5 ounce (#10) cans. The green beans were distributed to food service customers in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Mississippi, Missouri, North Carolina, Tennessee, and Virginia and sold through GFS Marketplace stores in Indiana, Kentucky, and Tennessee. There is no evidence of primary distribution outside the United States.
FDA
New Era has voluntarily recalled 171 cases of the green beans and the FDA, along with the Michigan Department of Agriculture, is investigating whether any other sources may be involved in the contamination.
FDA Warns About Potential for Botulism in Canned Green Beans