Caleb Alexander, a drug safety expert with Johns Hopkins Bloomberg School of Public Health, questions why drug trials exclude some patients, putting actual users at an increased risk for adverse drug effects. “Excluding someone who weighs over 250 pounds?” he said. “Come on. That’s one-fifth of America.”

“More robust safety protocols are urgently needed to prevent serious patient safety events in this high-risk population,” concluded another study.

Read the full article here.

Novartis pharmaceuticals knowingly used inaccurate data when applying for FDA approval of its $2.1 million gene therapy drug,” states FDA. The drug is the most expensive drug in the world, costing users $2.1 million per one-time use.

Criminal actions against the company may be taken. Read the full article here.

Researching the cocktails of drugs doctors prescribed to her young child, Ms. Parker discovered that one of the drugs was used as a sedative for violent inmates in Canadian prisons.

“I thought, if that’s being given to grown men in prison in Canada, why are you giving it to my child?”

Read the full article here.

Mefloquine, an anti-malaria drug known to cause severe adverse effects including hallucinations, insomnia, panic attacks, nightmares and suicide, may have precipitated a young British teen’s sudden death.

Guidance from the National Institute of Health and Care Excellence (Nice) says: “Mefloquine is associated with potentially serious neuropsychiatric reactions.

Read the full article here.

“Labeling can be confusing, vague, misleading, hidden in medical jargon or missing altogether,” said Rachel Brummert, a patient advocate and FDA special employee. “If prescription labeling were consistent, we could avoid many of the problems caused by inconsistent labeling.”

Read the full article here.

Prescription drug withdrawal can sometimes lead to permanent prescriptions. “Ten years on and I am still taking that antipsychotic, not because it proved to be an effective mood stabilizer, not because it improves my health in any way, but simply because I am physically incapable of sleep without it.”

Read the full article here.

Drug Safety Label Changes: A Target for Collaboration

“Communicating the most up-to-date information on a product’s safety to patients and providers is one of FDA’s most important functions,” said Mark McClellan, MD, PhD, director of Duke Margolis Center for Health Policy.

Collaboration is needed to help the FDA increase its understanding of the impact of postmarketing drug safety. Read the full press release here.

High drug costs can lead to people skipping their prescriptions. This can lead to many serious adverse drug effects to include withdrawal akathisia. Read the full article here.

Two new lawsuits charge many patients taking a Gilead HIV drug “needlessly suffered debilitating and sometimes fatal kidney and bone damage as well as damage to their teeth.” Read the full article here.

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We are grateful to all who help us increase awareness of adverse drug effects.