Bee pollen supplements pose deadly allergy hazard

 

People with pollen allergies may have allergic reactions, including anaphylaxis, from ingesting bee pollen.
People who take bee pollen supplements need to know that it can cause potentially life-threatening reactions in those with seasonal allergies, doctors warn.

Bee pollen is a natural health product made from pollen granules collected by bees. It’s touted to aid in weight loss and promotes longevity.

In Tuesday’s issue of the Canadian Medical Association Journal, doctors describe how they treated a 30-year-old woman who was referred to an allergy clinic after having an anaphylactic reaction from bee pollen supplements

“Anaphylaxis associated with the consumption of bee pollen has been reported in the literature, but many people remain unaware of this potential hazard,” wrote Dr. Amanda Jagdis of the University of British Columbia and Dr. Gordon Sussman of St. Michael’s Hospital and the University of Toronto.
“Patients with pollen allergies should be advised of the potential risk when consuming these products because it is not known who will have an allergic reaction when ingesting bee pollen.”
The problem can arise since bees collect a variety of pollens, including airborne ones that commonly cause allergies, such as ragweed.
In the paper, the woman had seasonal allergies but no history of allergies to food, drugs, insects or latex.
Her eyelids, lips and throat swelled, she had difficulty swallowing, hives and other life-threatening symptoms, the doctors said.
After emergency treatment, she stopped using the bee pollen supplements and had no other reactions.
In 2006, Greek investigators looked at the association between pollen and bee pollen allergy.
Among 145 patients and 57 healthy controls who had skin tests for reactions to bee pollen, 73 per cent of the allergy patients also had positive skin test reactions to at least one bee pollen extract.
The commercial pollen extracts tested included olive, grass and bugwort pollens.
The authors prescribed an auto-injector to the woman given the life-threatening nature of her reaction. They acknowledged that there’s controversy over the necessity of the prescription.
Sussman is a consultant for drug maker Pfizer and has received grants from Novartis and CSL Behring.

 

UPDATE: New Website Selling Miracle Mineral Solution Sodium Chlorite Solution 

 

Health Canada is advising Canadians that a new website has been identified selling “MMS”, also known as Miracle Mineral Solution or Miracle Mineral Supplement. Health Canada continues to remind Canadians that there are no therapeutic products containing sodium chlorite authorized for oral consumption by humans. MMS may cause serious health problems that include poisoning, kidney failure and harm to red blood cells that reduces the ability of the blood to carry oxygen. Additional health problems may also include abdominal pain, nausea, vomiting, and diarrhoea. 

 

Breaking News

 BG12 Update 
   
Oral BG-12, also known as dimethyl fumarateI, is being investigated as an oral treatment for people with relapsing-remitting multiple sclerosis (RRMS), and could receive FDA approval as early as mid-2012. The oral therapy may represent a new class in treatment for MS in that it appears to have dual anti-inflammatory and neuroprotective effects. Originally used to treat psoriasis, the drug received Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2008 as a treatment for MS. Biogen Idec—the company that makes BG-12—is now waiting for formal acceptance by the FDA of its New Drug Application (NDA).

BG-12, an oral fumarate derivative, has been shown to activate the Nrf2 transcriptional pathway—the first compound to do so. This pathway is thought to defend against oxidative-stress induced neuronal death, protect the blood-brain barrier, and support maintenance of myelin integrity in the central nervous system—all key elements to treating MS. According to Dr. Timothy Vollmer, Medical Director of the MS Center, in addition to its use as an individual therapy, the activation of this pathway may also make BG-12 a candidate for combination therapy.

PHASE III STUDIES

In April 2012, Biogen Idec announced that detailed positive results from CONFIRM, the second of two Phase III trials, will be presented at the 64th Annual Meeting of the American Academy of Neurology (AAN). The study enrolled 1,430 patients at 175 sites in North America, Europe and other parts of the world, and tested 240 mg of BG-12, which was given either twice or three times a day to RRMS patients, and compared to placebo. Glatiramer acetate (Copaxone) was given and tracked as a comparison. The goal was to assess the efficacy of the oral therapy compared to currently used injectable therapies, in this case Copaxone. 

The study reached its primary endpoint—i.e. goal—by reducing the annual relapse rates by 44% in those who received BG-12 twice a day, and 51% in those who received it three times a day—compared to placebo over two years. In study participants on Copaxone, relapse rate was reduced by 29% compared to placebo. 

Secondary endpoints were met as well. There was a reduction of 34% in the proportion of patients who relapsed (twice-daily BG-12), and 45% (three times a day) at the end of two years. Those on Copaxone demonstrated a 29% reduction. BG-12 reduced new or newly enlarging T2-hyperintense lesions as seen on MRIs by 71% in those on the twice daily dose and 73% for those on three-times-a-day dose. A 54% reduction was seen in Copaxone recipients. The number of non-enhancing T1-hypointense lesions was also reduced by 57% and 65% for those on BG-12, and 41% for those on Copaxone. There was also a reduction in the odds of developing gadolinium-enhancing (Gd+) lesions by 74% and 65% for BG-12 recipients, and 61% for those on Copaxone. 

At two years compared to placebo, the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), was reduced by 21% and 24% in study participants on BG-12. For those on Copaxone, the risk was reduced by 7%.

Data from DEFINE, the first of the two Phase III studies, had similar results. The study involved 1,234 patients at 160 different sites in North America, Europe and other parts of the world. Patients were dosed with placebo, BG-12 twice a day, or BG-12 three times a day. At two years, those taking BG-12 twice a day reduced the proportion of patients who relapsed by 49% and those taking it three times a day reduced the risk of relapse by 50%, compared with placebo. The risk of confirmed 12-week disability progression was reduced by 38% with people taking BG-12 twice a day and by approximately 34% with people taking it three times a day. The overall incidence of adverse and serious adverse events was similar among the placebo group and both BG-12 treatment groups.

Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically significant reduction in annualized relapse rate, in the number of new or newly enlarging lesions, and in the rate of disability progression as measured by the Expanded Disability Severity Scale (EDSS) at two years.

BG-12 has a favorable safety and tolerability profile. In CONFIRM, there was no evidence of suppression of the immune system and no increase in infections. Study participants on BG-12 experienced “hot flashes”, otherwise known as flushing, which tended to resolve after the first month, and some mild gastro-intestinal side effects of dyspepsia and diarrhea. The overall incidence of infection, adverse events and serious adverse events was similar among the placebo group and both BG-12 treatment groups. The safety profile was consistent with what was seen in the published Phase II study.

As it becomes available, more information on BG-12 and FDA approval of the therapy will be published here. Please stay tuned

Oral Drug: Ono-4641SOURCE: American Academy of Neurology  

An investigational oral drug called ONO-4641 reduced the number of lesions in people with multiple sclerosis (MS), according to the results of a phase two clinical trial to be presented as Emerging Science at the American Academy of Neurology’s 64th Annual Meeting in New Orleans this week.

For the study, 407 people between the ages of 18 and 55 with relapsing-remitting MS were randomly given placebo, 0.05 mg, 0.10 mg, or 0.15 mg of ONO-4641 once per day for 26 weeks. People were included in the study if they had two or more relapses in the two years prior to the study, one or more relapses within the year prior to the study or one or more new MS-related brain lesions, also known as Gd-enhancing lesions, detected on MRI within three months prior to the study. Brain scans were performed every four weeks from 10 to 26 weeks.

At the end of the study, people taking 0.05, 0.10, or 0.15 mg of ONO-4641 had 82 percent, 92 percent and 77 percent fewer Gd-enhancing brain lesions, respectively, compared to placebo.
Adverse events appeared to be dose related and included cardiovascular events, such as a slower heartbeat, blood pressure changes, and an AV block, which is the impairment of the conduction between the atria and ventricles of the heart. Other adverse events included liver enzyme elevations. In addition, grade four lymphopenia, which is an abnormally low level of lymphocytes in the blood, occurred in four percent of people receiving the 0.15 mg dose of ONO-4641 and in one percent of those receiving the 0.10 mg dose.

“In light of recent issues in the oral MS drug market, this is welcome news,” said study author Timothy Vollmer, MD, of the Rocky Mountain MS Center.
Stay tuned for more emerging news from the American Academy of Neurology’s 64th Annual Meeting.

Oral Treatment for MS on the Horizon

Oral Drug: Ono-4641SOURCE: American Academy of Neurology  
An investigational oral drug called ONO-4641 reduced the number of lesions in people with multiple sclerosis (MS), according to the results of a phase two clinical trial to be presented as Emerging Science at the American Academy of Neurology’s 64th Annual Meeting in New Orleans this week.
For the study, 407 people between the ages of 18 and 55 with relapsing-remitting MS were randomly given placebo, 0.05 mg, 0.10 mg, or 0.15 mg of ONO-4641 once per day for 26 weeks. People were included in the study if they had two or more relapses in the two years prior to the study, one or more relapses within the year prior to the study or one or more new MS-related brain lesions, also known as Gd-enhancing lesions, detected on MRI within three months prior to the study. Brain scans were performed every four weeks from 10 to 26 weeks.
At the end of the study, people taking 0.05, 0.10, or 0.15 mg of ONO-4641 had 82 percent, 92 percent and 77 percent fewer Gd-enhancing brain lesions, respectively, compared to placebo.
Adverse events appeared to be dose related and included cardiovascular events, such as a slower heartbeat, blood pressure changes, and an AV block, which is the impairment of the conduction between the atria and ventricles of the heart. Other adverse events included liver enzyme elevations. In addition, grade four lymphopenia, which is an abnormally low level of lymphocytes in the blood, occurred in four percent of people receiving the 0.15 mg dose of ONO-4641 and in one percent of those receiving the 0.10 mg dose.
“In light of recent issues in the oral MS drug market, this is welcome news,” said study author Timothy Vollmer, MD, of the Rocky Mountain MS Center.
Stay tuned for more emerging news from the American Academy of Neurology’s 64th Annual Meeting.