FDA investigation is underway
Reports have flooded in to the Food and Drug Administration in staggering numbers of 775 serious side effects of which included thirty deaths linked to the over the counter medication Tylenol that had been recalled by Johnson & Johnson subsidiary McNeil.
Consumers who endured these side effects after taking products which were part of one of four recalls issued by McNeil in recent months. The FDA will now decide if these medications were directly liable for any of these events. So far researchers have decided that most of the deaths which occurred had not been caused by the medications this was mentioned by a source to a congressional investigation.
The first mention of any side effects from the products had come in November 2009. At that time McNeil had recalled five lots of Tylenol Arthritis Pain 100 count with EZ-open caps. This had occurred after consumers had reported an unusual odor that had caused nausea, stomach pain, diarrhea and vomiting. Just one short month later, the company recalled all of the lots of this product.
The following month had brought more reports once again from consumers who were feeling ill linked with an unusual odor from other medications that belonged to McNeil. Upon that notice of reports, the company than recalled an undetermined number of Tylenol, Motrin, Benadryl among other over the counter medications. This recall of products had been manufactured between the period of January 1st , 2008 and April 30th , 2010.
In May of this year, McNeil had declared a separate for 50 versions of children over the counter medications of cold, allergy, cough and pain. This recall had been directly due to severe concerns over the products safety and quality. However, the company had stated that the recall was just careful prevention and not being taken because of any negative medical occurrences.
Currently, manufacturing is now suspended at the factory which produced these medications. The FDA has released a 17 page report stipulating greater than 20 violations that had occurred at the factory.
The FDA is also examining hundreds of reports due to serious side effects of the children recalled medications which had include seven deaths.
As of now the House Committee on Oversight and Government Reform has initiated their own investigation into the medication recalls.
Horrific conditions at the plant
David Lebo, professor of pharmaceutical manufacturing at Temple University in Philadelphia, issues statements regarding the May 6th, inspection report of the facility in Fort Washington, Pennsylvania.
Professor Lebo, remarks the inspection report is practically close to being the worse thing he has ever witnessed. The report is suggesting that the FDA found a problem with nearly all systems in the plant.
The most damaging aspect of the report was the allegation that the plant does not keep acceptable laboratory facilities concerning the testing and approval or rejection of elements of the drug products.
The report also had called attention to the fact McNeil never followed up on 46 complaints from consumers received June 29, 2009 to April 2010, in reference to foreign materials, black or dark specks. There are no further details that would be provided by either the company or the FDA.
The FDA also cited deficiency for proper controls in the manufacturing process that led to some batches of infant’s Tylenol being extra strong or containing too much of one ingredient.
Report keeps becoming worse as it progresses
It also is mentioned that the employees at the plant had no training in current good manufacturing practices. The inspectors of the FDA also specified conditions at the plant being dusty and filthy which had included incubators having an immense amount of visible gray and brown dust/debris, a large hole in the ceiling along with a heavy dust covering the grill inside a filtered cabinet.
The FDA also noted some of the drums which are used to send raw materials to the Fort Washington facility had been contaminated with bacteria which as been identified as B Cepacia. This bacteria have little risk to those in good health. However, those persons who have health issues such as weak immune system or chronic lung diseases, especially like cystic fibrosis can be more at risk for infections.
Actions that could happen
Currently, it is not clear as to what action the FDA may impose.
Action one possible is the FDA could totally close the plant. This according to professor Wertheimer professor of health economics at Temple University states this would cause the company to lose immense amounts of market shares in the over the counter medication category.
The FDA could also issue a consent decree. This means McNeil could continue production at the plant but would need a third party to consent to the medications. This could be extremely costly.
Johnson & Johnson has had four recalls within the period of seven months.
Maybe now is the time to look at alternative treatments
When a company as large as Johnson & Johnson starts having this many recalls and are facing issues with their manufacture of medications, it makes you wonder what is happening in the smaller companies which produce medications. Is it any wonder why persons are now going to alternative health practitioners.
A few basic alternative options
There are alternative treatments used daily on children. Did you know that chiropractic care is not only the top choice for alternative medicine today it is highly noted for children. Parents of children with asthma rate chiropractic care as the number one treatment for their children.
Chiropractors have extensive knowledge in the development of children and their needs. They check the spine for any signs of scoliosis, vertebral subluxations and nerve pressure caused by misaligned vertebrae. These type of misalignment’s can bring about interference in the informational flow from the brain to different parts of the body. If not treated it can cause numerous health issues for the child.
Among the numerous conditions chiropractic care can treat there are several common conditions in children that are treated on a regular basis such as allergies, ear infections, coughs, colds, sinuses, ADD, and asthma.
Acupuncture for children is gentle and mainly non-inserted needle treatments are used. These are a lot more comfortable for children.
One such technique is Ling Shu in which nine types of needles are used, among these are several which never pierce the skin.
Shonishin techniques are used which consist of rhythmic stroke, tapping and pressure to the skin in different areas to provide stimulation.
The Shonishin technique can be used to treat an assortment of issues including:
Failure to thrive
Cerebral Palsy among many others
The frequency, dose and strength is dependent upon the practitioner, age of child, the condition the child has and other things.
Herbal remedies are natural and a lot safer for children than over the counter medications. Children respond quicker to herbs to be healed. Herbs can be used on children from the common cold to chicken pox. Herbs have been known to calm the over active child and promote sleep in those who need it.
It is essential to remember that when using herbs for a child is that the dosage on most herbal supplements are aimed at adults who weight 150 pounds. Dosages would be needed to be adjusted accordingly.
Homeopathy is another alternative treatment that can be used for children. It is totally safe, has no side effects and the treatments are the same for children as adults.
The remedies used come from plants, minerals or animal substances.
Some treatments used in children include:
Chamomile for children that are hyperactive, restless and irritable. In can also reduce pain in babies who are teething or have colic.
Belladonna is used for fevers when the child has a flushed face, throbbing headache, is drowsy but cannot fall asleep easily and glands are swollen and producing heat. It is also used in the case of measles when there is the beginning of a high fever, face is flushed. Lips appear very red.
There are many alternative treatments available today. Most of them all are used on children and adults. Techniques and dosages just may vary between the two. With all that is happening with recalls and other factors in manufacturing medications may be it is time we used natural medicines.
Chiropractic Health Center