New warnings on how Rx and illicit drugs can be deadly, especially if mixed

gabapentin-300x158A widely prescribed drug, formally approved only for limited uses but now dispensed for many nerve-related conditions, can put patients at serious risk of breathing problems, especially if they are aged, suffer from all too common chronic obstructive pulmonary disease, or may also be taking opioid pain killers or other medications that depress the central nervous system.

That’s a toughened new warning about gabapentin and pregabalin from the federal Food and Drug Administration, which says it will require new packaging and cautions for the drugs. They may be better known in their branded versions as Neurontin, Gralise, Horizant (gabapentin) or Lyrica and Lyrica CR (pregabalin).

The nerve meds have been subject to “growing” medical “use as well as misuse and abuse,” the FDA said in a statement, adding:

“Gabapentinoids are often being combined with CNS [central nervous system] depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants, and antihistamines. There is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone. We will continue to monitor these medicines as part of our routine monitoring of all FDA-approved drugs.”

The drug won approval from the FDA a quarter century ago for treatment of seizure disorders. But it since has become a go-to medication for doctors who write “off-label” prescriptions for it to care for “all kinds of pain, acute and chronic, in addition to hot flashes, chronic cough and a host of other medical problems,” New York Times columnist Jane Brody wrote recently.

Lyrica — or pregabalin, a “brand-name cousin” of gabapentin — has become a top-seller for its maker Pfizer, generating more than $4 billion annually in revenue. Gabapentin and Lyrica, both sold by Pfizer, have “been FDA approved to treat only four debilitating pain problems: postherpetic neuralgia, diabetic neuropathy, fibromyalgia and spinal cord injury,” Brody reported. But “even for these approved uses, the evidence for relief offered by the drugs is hardly dramatic.”

She cited a study analysis by South Carolina researchers, who found that:

“In many well-controlled studies, they found there was less than a one-point difference on the 10-point pain scale between patients taking the drug versus a placebo, a difference often clinically meaningless. For example, among 209 patients with sciatica, Lyrica did not significantly reduce the intensity of leg pain when compared with a placebo, and dizziness was more commonly reported by the 108 patients who took the drug.”

Still, as Brody reported, “when patients complain of pain related to conditions ranging from sciatica and osteoarthritis to foot pain and migraine, clinicians often reach for the prescription pad and order either gabapentin or the more costly Lyrica.”

The medical news site MedPageToday said that:

“Prescription use of gabapentinoids increased from 2012 to 2016, the [FDA] reported. The estimated number of patients filling a gabapentin prescription annually climbed from 8.3 million to 13.1 million in that period, while the number filling a pregabalin prescription rose from 1.9 million to 2.1 million.”

The Associated Press noted that the FDA “said it received nearly 50 reports of breathing problems linked to gabapentin and pregabalin between 2012 and 2017, including 12 deaths. While drug makers are required to report problems to the FDA, it’s voluntary for doctors and patients.”

The agency has asked patients, as well as physicians and others medical staff, to report problems with these medications. Regulators already know that the “common side effects of gabapentinoids include drowsiness, dizziness, blurry or double vision, difficulty with coordination and concentration, and swelling of the hands, legs, and feet.”

Meth deaths rising

Interactions among patients’ medications, combined with significant and persistent substance abuse, persist as a major cause of concern for the nation, officials have warned.

The New York Times, separately, has reported on officials’ alarm about a spike in deaths due to overdoses of methamphetamines — not the once common, home-concocted versions involving pseudoephedrine, the main ingredient in many drugstore cold medicines but deadlier and much more potent drugs coming in from Mexico. The newspaper reported that:

Provisional data from the [federal Centers for Disease Control and Prevention] shows there were about 13,000 deaths involving meth nationwide in 2018, more than twice as many as in 2015. That is still far fewer than opioid deaths overall, which passed 47,000, but the pace is accelerating while opioid fatalities have flattened.”

The FDA warning about gabapentinoids may be pertinent to consider with the scary news about increasing meth abuse. That’s because, as the New York Times noted, “meth stimulates the central nervous system, causing agitation, sleeplessness, psychosis and gradual damage to the heart, brain and other organs.” The boost that abusers get from meth may be their way to counteract the downer effects of potent opioid painkillers, including the frightening and powerful synthetic fentanyl, as the newspaper reported:

Research suggests that in some cases, fear of dying from fentanyl is compelling people to use meth instead. Others are using meth as an upper to rouse themselves after using opioids, which have a sedative effect, or to help with opioid withdrawal. Still others are turning to meth for a high even as they take anti-craving medications to recover from opioid addiction.”

Popping too many pills

Lest anyone think that it’s dangerous to mix up powerful drugs in such a fashion — and, yes, it is, extremely so — the New York Times also reported on serious problems among older adults with “polypharmacy,” the taking of multiple drugs and other substances in indiscriminate fashion. As the newspaper noted, in what may almost an annual caution on this issue:

“According to the American Society of Consultant Pharmacists, people aged 65 to 69 take an average of 15 prescriptions a year, and those aged 80 to 84 take 18 prescriptions a year. And that’s in addition to the myriad over-the-counter drugs, herbal remedies, vitamins and minerals they may take, any of which — alone or in combination — could cause more problems than they cure. Among people over 65, 44% of men and 57% of women take five or more nonprescription and/or prescription drugs a week, and 12% take 10 or more. Many of these supposed remedies are unnecessary or used incorrectly and can result in distressing and even dangerous side effects.”

Columnist Brody (again) offers excellent, common sense ways for grown-ups to avert polypharmacy’s disastrous consequences, including: getting off unneeded meds by adapting healthier practices so the meds can be discontinued; ensuring all caregivers involved, especially the pharmacist, know what drugs and other items patients may be taking; and using organizing systems (pill minder products or special, daily dosage packaging).

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the havoc that can be inflicted on them and their loved ones by dangerous drugs. It’s the complete mess of the U.S. health care system that Americans pop too many pills — and we get gouged for the prescription medications that we need most but may have least access to, as a result.

Big Pharma unchecked

Big Pharma and politicians, meantime, not only keep pushing bad stuff on us, they’re enriching themselves and, regulators, especially, are failing to safeguard the public from harms, as well. To anyone who doubts the accuracy of that view, please take a look at the building coverage of the plutocratic Sackler family, and how, even as the opioid crisis became more lethal by the day, they demanded that their drug-making empire churn up ever more cash for their lavish lives, and, yes, philanthropy.

Or consider information emerging from an employee lawsuit against drug distributor McKesson, as reported by the industry publication Modern Healthcare. It said that plaintiffs in that case assert that “the wholesale drug distribution giant claim that McKesson [hid] the extent of its security issues from the federal government and falsely represented that it would comply with two settlement agreements. Millions of the addictive pain pills were diverted to the black market as a result, according to the lawsuit. Those actions violate the False Claims Act, the whistleblowers argue, and the company’s alleged negligence and overt malpractice stoked one of the largest public health crises in history.”

As for the affordability of prescription drugs, it’s worth noting that, in the midst of huge dickering over the $1.4 trillion U.S. budget bill, the Trump Administration and congressional Republicans bent to Big Pharma’s sway and no cost containment measures will be enacted this year. House Democrats passed a bill, but it foundered in the GOP-controlled Senate, under the iron grip of Majority Leader Mitch McConnell. The president and his cabinet, meantime, offered a wan plan to move toward allowing states to import lower-cost drugs safely from Canada.

Really? That’s the best that Americans have on offer — to hope, some time soon, that they might get help from our smarter and unhappy neighbors (at least on prescription drug prices) up north?

We’ve got a lot of work to do as a new decade dawns to ensure our drugs are safer and more affordable and we deal with them in much saner ways.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information