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FDA Calls Out Pharma and Drug Store for Unauthorized Dengue VaccinationsAlso: TRO on contraceptives could be lifted, says the DOH, and prolonged use of ibuprofen could cause heart attack.by Anne Jeline Lacon .
FDA calls out Watsons, Sanofi for unauthorized dengue vaccinations
The Food and Drug Administration (FDA) has ordered Sanofi Pasteur Inc. and Watsons Personal Care Stores to stop conducting immunization activities using Sanofi’s dengue vaccine, Dengvaxia, without authorization, because it may cause “a potential health hazard to the consuming public.”
According to the agency, it had not issued any authorization to allow immunization services to be conducted by Sanofi, Watsons, or any drug store.
This came about after Watsons announced that it was making the vaccine available at their stores, starting April at P4, 000 a dose, a move that the FDA's Center for Drug Regulation and Research closely monitored.
Consequently, the personal care store posted an announcement on its Facebook page on April 27 informing the public that the scheduled vaccination has been postponed.ADVERTISEMENT - CONTINUE READING BELOW
“Compliance with the law is not optional especially when the safety and health of the public are involved,” the FDA director general Nela Charade Puno stated.
The FDA is calling out to the public to report unauthorized immunization activities in drug stores via an e-mail to report@FDA.gov.ph, or at the FDA’s online reporting facility at www.fda.gov.ph. (inquirer.net)
DOH confident that Supreme Court will lift TRO on contraceptives
Dr. Enrique Tayag eased concerns surrounding the Supreme Court's Temporary Restraining Order that put heavy restrictions on the distribution and purchase of contraceptives in the Philippines.
As spokesperson of the Department of Health, he says he is confident that the Supreme Court will make a wise decision and lift the TRO. "We are confident that the Supreme Court will respect the rights of Filipino women," although they are preparing for the worst-case scenario.
The TRO prohibits the government from buying or distributing pills, injectables, intrauterine devices, implants, vaginal rings, among others, and has also kept the FDA from issuing a certificate of product registration (CPR) to certain contraceptive drugs and devices.ADVERTISEMENT - CONTINUE READING BELOW
A list of contraceptives affected by the TRO and the date of the expiration of their CPRs will be announced by the DOH for reference.
In March, the DOH and the Office of the President filed an urgent motion to lift the TRO, which has been in effect since 2015. (gmanetwork.com)
Taking Ibuprofen for a week increases chance of a heart attack by 50%
Medical experts warn that some common anti-inflammatory drugs, including ibuprofen, can increase a person's risk of cardiac arrest by around 50 percent after only one week of taking them.
New research published in The BMJ shows that non-steroidal anti-inflammatory drugs (known as NSAIDS) can cause greater risk of a heart attack. People who take the painkillers for a week or more will have between 20 percent and 50 percent more chance of a cardiac arrest than those who didn't consume the drugs.
In March this year, a Copenhagen University Hospital Gentofte research also revealed that NSAIDs, including ibuprofen, aspirin and naproxen can increase the risk; however the study revealed that ibuprofen alone caused an increased risk of heart attack by 50 percent. A cardiology professor from the Copenhagen University Hospital, Gunnar Gislason, said that people should only take these kind of painkillers when absolutely necessary, and that people who have a history of heart problems should avoid the medication altogether. (goodhousekeeping.com)ADVERTISEMENT - CONTINUE READING BELOW