(SimonQ, CC BY-NC-ND 2.0) Acetaminophen kills hundreds of Americans every year, sending thousands to the emergency room with at least 2,600 hospital admissions.
Presently, the drug manufacturer is defending itself in federal court from at least 85 different lawsuits from consumers claiming harm and from surviving family members claiming wrongful death, with heartrending anecdotes about the deceased. During the past decade, hundreds of Americans have died after unintentional overdoses of the country’s most popular pain reliever.
Nearly 500 Americans die yearly from acetaminophen overdoses, with 2,600 hospitalizations and some 56,000 emergency room visits, according to a 2004 study from the University of Texas. The drug is also implicated in nearly half of all cases of liver damage, researchers say. At the same time,the Tylenol brand makes more than $1 billion in revenue every year, aside from competitors.
Although the U.S. Food and Drug Administration (FDA) refers to acetaminophen overdose as a “persistent, important public health problem,” regulatory oversight of the drug — safe for adults, children, and infants in the right doses — has been criticized by some as too lax, compared to other developed countries from Europe to Asia. U.S. regulators ruled in 2009 to require a label warning of “severe liver damage” after convening an expert panel in 1977 — 32 years later.
I have posted on how Ranbaxy and Johnson and Johnson sell at a higher price/spurious products and how Johnson and Johnson is relaunching the same product that was whose licence was canceled for using a Carcinogen in the formula.
Some Retailers allow a discount of 20% on MRP, while periodically going on strike for increased margins.
On checking up with a Retailer well known to% discount , in some products, they make at least 30 % Margin!
Imagine the profit the Drug Companies are making!
The net profit of the Drug Companies are making is very high after paying out millions of Dollars paid out to doctors for prescribing their products!
Nine drug makers, including Ranbaxy, Dr Reddy’s Labs, Glenmark, Cipla and Cadila Health, are likely to face a hefty penalty from the National Pharmaceutical Pricing Authority (NPPA) over allegedly selling anti-asthma drugDoxofylline without prior price approval. The move comes in the wake of a recent Supreme Court order against the industry that brought the widely prescribed medicine under price control.
The total penalty on the nine firms is estimated to be Rs 2,500 crore because the fine will be calculated in retrospect from 2009, when the price of the drug was fixed by NPPA.
According to official sources, NPPA has already sent notices to four drug companies — Ranbaxy, Cipla, Cadila and Glenmark — for allegedly overcharging on sale of their individual brands containing Doxofylline.
I had posted articles on how Ranbaxy had fallen short of FDA Standards and Johnson & Johnson Product Licence was canceled in India for the presence of Carcinogen.
Ranbaxy
However I have received emails and in the form of comments to that post(Johnson and Johnson) expressing a desire to continue with their products on the ground that they are being used for quite a number of years and would I mail more information on the subject.
I hold no grudge against Pharma Companies, so long as what they produce is of acceptable standard and are not exorbitantly Priced.
A suspicion and a report that the Products are suspect or have failed tests is sufficient for me to inform people to stop using the products for we are dealing with Lives.
One should know that FDA of US also has corrupt Officials(Please read The Final Diagnosis of Arthur Hailey) and when FDA issues warning it must be understood that they are being issued despite Money and Political Pressure.
Yet the desire to continue with their products persists, such is the power of Television Advertisements!
Now I find Johnson & Johnson coming out with very catchy advertisements in TV placing the Products as a family’s Trusted product for the same Product that was banned.
“We understand their concerns and are diligently working with them to resolve the issue,” Peggy Ballman, a J&J spokeswoman, said in a statement, adding that there were no consumer complaints or adverse events reported due to its use of the process. An investigation by the Maharashtra Food and Drug Administration revealed that J&J, at its plant in Mulund, had used ethylene oxide – a substance used to produce industrial chemicals and to sterilize medical equipment – to kill bacteria in its baby powder and had not conducted mandatory tests to make sure there were no remaining traces in the powder. According to the U.S. Department of Labor, acute exposure to ethylene oxide can cause lung damage, nausea, vomiting and cancer.
As for as Ranbaxy is concerned, it has been served with Notices, not once, but Five Notices in Five Years!
The following are examples of the observations that support our conclusion that Ranbaxy submitted untrue statements of material fact in drug applications filed with the Agency: 1. Ranbaxy submitted stability information in numerous approved and pending applications that contain untrue statements of material fact, because Ranbaxy failed to include critical information about the storage and testing of the product. During a February 2006 inspection of the Paonta Sahib manufacturing facility, FDA found that hundreds of stability samples, many of which were being used for room temperature or accelerated stability studies, were being stored in refrigerators at approximately between the time they were removed from their stability chamber and the time they were tested. Among other things, FDA investigators found that the sample logbooks did not identify the samples that were being held in the refrigerators, their storage duration in the refrigerators, and the justification for this storage. FDA issued a June 15, 2006 warning letter to Ranbaxy based on its findings during this inspection, including the circumstances of these refrigerated stability samples.
Media was coy of disclosing that the product, baby Powder contained Ethylene oxide,a cancer causing agent, a Carcinogen.
This agent is used in baby Lotion,Baby Oil as well.
As I understand it is a chemical used to prevent the product getting spoiled.
This additive is used to increase the shelf life of the product.
But it causes cancer.
Many food and cosmetics contain this additive.
Am posting a blog on the ingredients to avoid in Food Products.
Check the product before you buy with this list.
Johnson & Johnson range of products,
The Food and Drug Administration (FDA) recently cancelled Johnson & Johnson India’s licence to produce cosmetic products at their Mulund plant. FDA’s order will come into effect from June 24. According to FDA officials, the order was issued in a case dating back to 2007 when they found that 15 batches of Johnson & Johnson baby powder were sterilised by ethylene oxide, a known carcinogenic and irritant.
“While ethylene oxide can be used for sterilisation, the company did not bother to carry out a test after the process to check the amount of residue in the product,” said FDA joint commissioner KB Shende, adding that the company can appeal to the State government before the order comes into effect.
“The products are used for new born babies. It is must for the company to follow all measures,” said Shende adding that the traces of ethylene oxide, if any, should have been measured. The 15 batches in question consisted of 1,60,000 containers. When Mirror contacted Johnson & Johnson, the company spokesperson confirmed the FDA action.
“Nothing is more important to us than the safety of our products and health of the consumers. We continue to manufacture non-cosmetic products at the same site,” the spokesperson said, adding that the matter in question related to a limited number of batches produced in 2007, shelf life of which ended in July 2010. “The FDA raised concern about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA.
This method is widely used for medical devices around the world. This was followed as an exception and all internal safety protocols were followed to ensure that safety of the consumer was not compromised.
”
Ethylene Oxide is very important material used in large-scale chemical production. It also produces ethylene glycol, one of the components used in plastics. Ethylene Oxide has been used globally to produce solvents, lubricants, paint thinners and detergents.
How Dangerous Is It?
At room temperature, ethylene oxide is very dangerous; the chemical is flammable, carcinogenic, mutagenic, and irritating. It is an anaesthetic gas with a misleading pleasant smell.
What Effects Can It Do to Humans?
Unprotected and constant exposure to ethylene oxide can cause genetic mutation or DNA alternation which leads to cancer. It can damage the lungs and the cardiovascular system. Physical manifestation after exposure includes headache, vomiting, dizziness, sleep disturbances, leg pain, weakness, stiffness, sweating, liver enlargement and suppression of antitoxic functions of the body.”
Ethylene oxide is toxic by inhalation with an U.S. OSHA permissible exposure limit calculated as a TWA (time weighted average) over 8 hours of 1 ppm, and a short term exposure limit (excursion limit) calculated as a TWA over 15 minutes of 5 ppm. [29 CFR 19101.1048]. At concentrations in the air about 200 parts per million, ethylene oxide irritates mucous membranes of the nose and throat; higher contents cause damage to the trachea and bronchi, progressing into the partial collapse of the lungs. High concentrations can cause pulmonary edema and damage the cardiovascular system; the damaging effect of ethylene oxide may occur only after 72 hours after exposure.[17] The maximum content of ethylene oxide in the air according to the U.S. standards (ACGIH) is 1.8 mg/m3.[113]NIOSH has determined that the Immediately Dangerous to Life and Health level (IDLH) is 800 ppm.[114]
Because the odor threshold for ethylene oxide varies between 250 and 700 ppm, the gas will already be at toxic concentrations when it can be smelled. Even then, the odor of ethylene oxide is sweet, aromatic, and can easily be mistaken for the pleasant aroma of diethyl ether, a common laboratory solvent of very low toxicity. In view of these insidious warning properties, continuous electrochemical monitors are standard practice, and it is forbidden to use ethylene oxide to fumigate building interiors in the EU and some other jurisdictions.[115]
Ethylene oxide causes acute poisoning, accompanied by the following symptoms: slight heartbeat, muscle twitching, flushing, headache, diminished hearing, acidosis, vomiting, dizziness, transient loss of consciousness and a sweet taste in the mouth. Acute intoxication is accompanied by a strong throbbing headache, dizziness, difficulty in speech and walking, sleep disturbance, pain in the legs, weakness, stiffness, sweating, increased muscular irritability, transient spasm of retinal vessels, enlargement of the liver and suppression of its antitoxic functions.[108]
Ethylene oxide easily penetrates through the clothing and footwear, causing skin irritation and dermatitis with the formation of blisters, fever and leukocytosis.[108]
The median lethal doses (LD50, or a dose required to kill half the members of a tested population after a certain time) for ethylene oxide are 72 mg/kg (rat, oral) and 187 mg/kg (rat, subcutaneousinjection).[116]
Conclusion
The Committee notes that estimated current intakes of ethylene oxide from the few food
additives containing it, conforming to present specifications, are very low. However, since
ethylene oxide is both genotoxic and carcinogenic, intakes from food sources should be as
low as possible. The Committee has been informed that the currently achievable limit of
detection for ethylene oxide is well below the upper limits of 0.5 mg/kg proposed for EHEC
or the 1.0 mg/kg currently specified for E431-436. The Committee therefore recommends that
the specifications of additives manufactured using ethylene oxide should be revised to restrict
ethylene oxide as an impurity to below its current limit of detection.
The Committee will comment on 1,4-dioxane, ethylene chlorohydrin and mono- and
diethylene glycol as impurities in additives in subsequent opinions.
Couple of days ago, my daughter told me that Johnson and Johnson ‘ the makers of child care products’ like Baby Powder,Baby Soap,baby Oil was banned.
Somehow I missed the news as it was not highlighted in the Media, such is the power of Advertiser finance to the Media.
Of course there are exceptions.
Johnson and Johnson’s Licence canceled
It is not merely Johnson and Johnson.
We have Complan claiming that children will go twice Taller(?,
Horlicks has ‘Brian Boosters”,’Is the Brain Dead? and what is this Booster?
Bournvita,’Twice the Stamina’-who has defined Stamina and how does one measure it?
Pepsodent sensitivity, ‘cures sensitivity twice as fast’
I can go on.
Johnson and Johnson was caught not for the misleading ads, or for the harmful effect of the products but for following a different process.
Easy to wriggle out in Court.
May be they have not paid enough to the people, they got caught as a waning to ensure prompt payment.!
Health officials have revoked Johnson & Johnson‘s license to make cosmetics at a plant outside Mumbai after they discovered the company had used an unauthorized process for sterilizing its baby powder.
J&J said in a statement on Friday that it is in “ongoing discussions” with Indian regulators.
“We understand their concerns and are diligently working with them to resolve the issue,” Peggy Ballman, a J&J spokeswoman, said in a statement, adding that there were no consumer complaints or adverse events reported due to its use of the process.
An investigation by the Maharashtra Food and Drug Administration revealed that J&J, at its plant in Mulund, had used ethylene oxide – a substance used to produce industrial chemicals and to sterilize medical equipment – to kill bacteria in its baby powder and had not conducted mandatory tests to make sure there were no remaining traces in the powder.
According to the U.S. Department of Labor, acute exposure to ethylene oxide can cause lung damage, nausea, vomiting and cancer.
Ballman said the plant has not been shut down and the company is appealing the decision. She said the sterilization process in question was used on a one-time basis on a limited amount of baby powder. Baby powder is made from corn or talc and is usually sterilized using steam, she said.
“For a brief time in 2007, we used an alternative sterilization process,” she said.
Ballman was unable to explain why the alternative process was used but said it is a “widely accepted and safe practice of sterilization used
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