New questions on safety, for old and young, about medications for the mind

paxil-300x300Psychiatric medications, which doctors have prescribed freely and patients have taken dutifully, not only may have demonstrated risks for the young but also under-considered problems for adults older than 40 — 1 in 7 of whom has filled a script, for example, for an antidepressant.

The New York Times has done a service by bringing to the fore some lesser known issues of psych meds by reporting on a successful lawsuit involving a 57-year-old Chicago lawyer. He apparently suffered from severe physical and mental agitation after he started taking paroxetine, the generic form of the brand-name drug Paxil. His anxiety became so acute, a jury found, the lawyer threw himself fatally in front of an oncoming train.

Antidepressants, including Paxil, long have been controversial for the young, especially after reports cropped up describing serious issues with their use. All such meds have carried a “black box” warning label, reviewed and approved by the federal Food and Drug Administration, warning that they increase the risk of suicidal thinking and behavior in children, teens, and those younger than 25.

But the suit by the lawyer’s widow against the drug’s maker, the news organizations has reported, has “lifted the curtain on data from early clinical trials of Paxil, renewing concerns that older adults, who use antidepressants in far greater numbers than young people, may also be at greater risk of self-harm when taking the drugs.”

They have become widely prescribed, with 325 million scripts filled last year for antidepressants, including 15 million for Paxil and its generic version. One in 5 American women older than 40 has filled an antidepressant prescription.

Doctors say the drugs, typically, are well-tolerated and help patients. It is difficult to sort out potential harms with psych meds, because the mental illnesses they aim to treat, especially in severe forms, often can lead to patients’ harming themselves.

Still, if the drugs can turn deadly, don’t doctors and patients need to consider this risk more?

In my practice, I see not only the major harms that patients suffer while seeking medical services but also their terrible suffering due to dangerous drugs, including psych meds.

It has been baffling, frustrating, and angering how doctors and patients take so lightly medications for the mind and mental illness. Regulators were far too slow to crack down on nursing homes’ dispensing powerful meds like Risperdal, Seroquel, and Zyprexa—abetted by Big Pharma— to calm geriatric patients into zombie-like compliance. It’s infuriating now, years after, doctors still and all too readily order anti-psychotics prescribed, off label, for pediatric patients, some younger than 2.

Indeed, besides MDs being too quick to whip out their pads for some crazy psych drug orders for patients, it is worth noting that modern medicine seems stone-aged in thinking about how medications profoundly affect children.

It’s good news that an FDA panel has recommended that the agency stop allowing powerful opioid painkillers to be part of prescription cough medicines, especially for patients ages 6 to 12, and 12 to 18. The risks from drugs like codeine and hydrocodone for kids far outweighs benefits they might receive from cough suppressants containing them, experts have told the FDA.

It’s also good news that FDA officials want to close a bizarre loophole (one of many) affecting kids and as part of the lax oversight of orphan drugs.  These are medications that may already be on the market but which can become exceedingly lucrative to Big Pharma after they are FDA-designated for treatment of diseases affecting a relatively small number of Americans (fewer than 250,000 patients nationwide).

Kaiser Health News, an independent and nonpartisan health information news service, and National Public Radio deserve credit for their investigation of orphan drug abuse, and for getting the FDA to move to end a legal twist in oversight of the drugs: When makers now get the FDA to move their medications into orphan status to treat rare diseases among youngsters, this designation, weirdly, also exempts the manufacturers from conducting test on kids of the drugs’ effects. Geez, that’s enough bureaucratic mind bending to make us all want to go out for a walk or take a drink.

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