Johnson & Johnson's Licence for Cosmetics Cancelled

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.   In addition, we have ascertained that there were no complaints or unexpected/ undesirable effect reported concerning any of the batches in question,” he said adding that the company is now in the process of filing an appeal with the state government. Ethylene oxide is a known carcinogen. The organic compound is known to be flammable, irritating, anaesthetic and carcinogenic at room temperature. The USFDA has recommended that companies should measure the residue of ethylene oxide after sterilisation of products and before releasing the products in the market.  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 -  Spokesperson for J&J

Exploding Head Syndrome

Exploding head syndrome is a rare and relatively undocumented parasomnia event in which the subject experiences a loud bang in their head similar to a bomb exploding, a gun going off, a clash of cymbals or any other form of loud, indecipherable noise that seems to originate from inside the head. Contrary to the name, exploding head syndrome has no elements of pain, swelling or any other physical trait associated with it. They may be perceived as having bright flashes of light accompanying them, or result in shortness of breath, though this is likely caused by the increased heart rate of the subject after experiencing it. It most often occurs just before deep sleep, and sometimes upon coming out of deep sleep.

Attacks can increase or decrease with time, and can disappear for long stretches at a time, or entirely, of their own volition. Subjects often feel fear or distress after the incident.

People over the age of 50 are most likely to experience exploding head syndrome. Women are at a higher rate of experiencing it than men. It has been reported in people as young as 10 years old.

Exploding head syndrome is thought to be highly connected with stress and extreme fatigue in most individuals. What actually causes the sensation in individuals is still unknown, though speculation of possible sources includes minor seizures affecting the temporal lobe, or sudden shifts in middle ear components.

As exploding head syndrome is not dangerous, and does not have a drastic effect on sleep, many individuals do seek help for their symptoms. It will first be necessary to consult with a doctor regarding your sleep and medical history to ensure that what the individual is experiencing is actually exploding head syndrome and not something else. Similar experiences have been known to be brought on by certain medications or drugs.

One medication that has been used to treat exploding head syndrome is clomipramine, a tricyclic antidepressant.

If stress is causing the episodes, it is advised to either seek to clear the problem. This could include reading, yoga, relaxing music or a hot bath before bed. These steps have also demonstrated to have positive effects in achieving quality sleep in general.

If the disturbances are the result of sleep deprivation, it is recommended to institute a more balanced routine that includes a minimum of 6 hours of sleep per night. If sleep deprivation is being caused by other sleep related disorders, these should be evaluated.

Source: ASA

Drug Patent Expirations for the week of April 21, 2013

Drug Patent Expirations for the week of April 21, 2013

Tradename	Applicant	Generic Name	Patent No.	Patent Expiration
AZOPT	Alcon Pharms Ltd	brinzolamide	5,461,081*PED	Apr 24, 2013
ZELNORM	Novartis	tegaserod maleate	5,510,353	Apr 26, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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PHARMATHON EDUCATIONAL SERVICES

JSS UNIVERSITY ADMISSIONS 2013-2014

Require Assistant Professor and Associate Professor in G.Pulla Reddy College of Pharmacy | Pharmaceutics, Pharma Analysis, Pharmacology, Pharma. Chemistry

Drug Patent Expirations for the week of March 31, 2013

Tradename	Applicant	Generic Name	Patent No.	Patent Expiration
BROVANA	Sunovion	arformoterol tartrate	6,589,508	Apr 3, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.