Drug & Device News

Results of a meta-analysis that looked at more than 600 trials of nonsteroidal anti-inflamatory drugs (NSAIDs), show that the risks of heart attack with high doses is greater than previously thought, according to the study's authors. Analysis of aspirin was not included in the study, whose results were published in the May 30 online edition of The Lancet, but other over-the-counter and prescription NSAIDs, like Motrin, Advil and Celebrex, were. The research results suggests that naproxen is one NSAID that is not likely to increase heart-attack risk, although it is not a perfect solution for all those seeking to relieve chronic pain because it causes many patients gastrointestinal problems.

Malaria Drug Gets New Boxed Warning

The FDA announced July 29 that makers of Mefloquine Hydrochloride, a drug used to prevent and treat malaria, have added new boxed warnings to their labels concerning newly discovered neurological and psychological side-effects of the drug. These side-effects ' including dizziness, loss of balance, ringing in the ears and/or feelings of anxiety, mistrust and depression ' can last for months, or possibly indefinitely. The agency recommends that those who experience any of these symptoms with use of Mefloquine Hydrochloride should consult with their health care providers before discontinuing its use. For more information, go to http://1.usa.gov/14nGO1T.

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Appeals Court: Mother Abused Child by Taking Prescribed Medication

A New Jersey appellate court has determined that an expectant mother who takes doctor-prescribed methadone during her pregnancy can legally be held responsible for child abuse in that state for exposing her unborn child to a dangerous and addictive drug. DYFS v. Y.N., A-5880-11. The case brings up several questions, including these: Should an unborn child's welfare be protected over a pregnant woman's health, and what duty does a physician owe to his patient's fetus? In the New Jersey case, the woman had been advised that her use of methadone could harm her unborn child, but she chose to go ahead with the treatment. Her baby was born with symptoms of methadone withdrawal and had to be treated with morphine for 39 days following his birth. The appeals panel focused its inquiry solely on the child's welfare and was unswayed by the fact that the mother was taking methadone under the care of a licensed medical care provider who prescribed the drug to her to wean her off of heroin and cocaine. It distinguished a 2012 case in which a mother who was somewhat impaired due to the use of Xanax during her pregnancy was not found guilty of child abuse. The difference, said the court, was that the child born with Xanax in its system was not addicted to the drug, while the child in' DYFS v. Y.N. was born addicted to methadone.

Study Cautions Against Use of High Doses of NSAIDs

Results of a meta-analysis that looked at more than 600 trials of nonsteroidal anti-inflamatory drugs (NSAIDs), show that the risks of heart attack with high doses is greater than previously thought, according to the study's authors. Analysis of aspirin was not included in the study, whose results were published in the May 30 online edition of The Lancet, but other over-the-counter and prescription NSAIDs, like Motrin, Advil and Celebrex, were. The research results suggests that naproxen is one NSAID that is not likely to increase heart-attack risk, although it is not a perfect solution for all those seeking to relieve chronic pain because it causes many patients gastrointestinal problems.

Malaria Drug Gets New Boxed Warning

The FDA announced July 29 that makers of Mefloquine Hydrochloride, a drug used to prevent and treat malaria, have added new boxed warnings to their labels concerning newly discovered neurological and psychological side-effects of the drug. These side-effects ' including dizziness, loss of balance, ringing in the ears and/or feelings of anxiety, mistrust and depression ' can last for months, or possibly indefinitely. The agency recommends that those who experience any of these symptoms with use of Mefloquine Hydrochloride should consult with their health care providers before discontinuing its use. For more information, go to http://1.usa.gov/14nGO1T.

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