Currently viewing the category: "drug"

FDA Makes Good

By On · Add Comment · In 17P, compounding pharmacies, drug, FDA, KV Pharmaceutical, Makena, progesterone
As a follow-up to a story I posted on earlier, the FDA has said it will not stop the sale of a cheaper version of a drug used to prevent premature births in women.  The drug, called Makena is a progesterone synthetic, which has been made cheaply for years, mixed in compounding pharmacies that are not federally approved.  The FDA said previously that it would enforce regulations against any compound pharmacies mixing the drug, upholding a federal order to allow one company, KV pharmaceutical, to be the sole producers of Makena.

This news comes as a relief for both women and doctors, as previous reports disclosed that the price would jump from $10-$20 to $1,500 for the once-a-week shot.  The FDA released a statement today saying, “In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies” that compound the drug, also known as 17P.

What makes this story unique is that when pharmaceutical companies usually develop a new drug, some pharmacies may try to make a version of the licensed drug after it comes on the market. But in this instance, pharmacies were making it before KV Pharmaceutical.  It was only the government mandate allowing KV sole manufacturing rights that changed things.  What’s more, the FDA’s regulation of special pharmacies is “a gray area” based on agency policies, not laws, noted Alvin J. Lorman, a respected Washington, D.C.-based food and drug lawyer.

Well bravo to the FDA for holding out on enforcing a bad policy.  And shame on the feds for scratching the back of a solitary pharmaceutical company at the expense of at-risk pregnant women.  Thank goodness there was enough of a public outcry to prompt good decision making by the FDA.  Sometimes our voices can be heard, and this is definitely one of those cases.  Good job, people!

Whippets in L.A.

By On · Add Comment · In asphyxiation, Assemblyman Tom Torlakson, brain damage, California, drug, inhalants, laughing gas, Los Angeles, nitrous oxide, Senate bill AB 1015, whippets
Can anyone guess which drug is being used most commonly by middle schoolers in Los Angeles? Not marijuana, no, no…it’s inhalants. And the number one inhalant of choice–you guessed it you aspiring dental students and rocket scientists–good ol’ nitrous oxide. Ha, ha, ha, ha…oh, ‘scuse me–laughing gas in the form of whippet cartridges. You know them; they are for whipping up cream, and they’re easy to get at gas stations, head shops and in other common household items.

Well California has had enough. From L.A. times: In response to reports from schools and law enforcement of increasing incidents, Assemblyman Tom Torlakson (D-Antioch) introduced legislation that would prohibit the sale or distribution of nitrous oxide, including whippets, to anyone under 18. The bill, AB 1015, has passed the Senate Public Safety Committee and is scheduled for a floor vote in August.

Why the big deal? Because whippets can cause irreversible brain damage and there have been a few reported deaths. Recently, three students at Madison Middle School in North Hollywood were hospitalized from allegedly abusing inhalants; and at Roosevelt High in Downtown L.A., a student who had been allegedly been huffing inhalants lost consciousness and had to be resuscitated. Over the 4th of July weekend, a Boyle Heights man was found dead, his closet filled with computer dust remover canisters (another source of inhalants).

Inhalants are used for their analgesic (pain killing), euphoric, and slight hallucinogenic effects. It is addictive. The dangers are that it can cause asphyxiation, short-term decreases in mental performance, audiovisual ability, and manual dexterity, deplete vitamin B12 causing deficiency, and cause nervous system damage.

Here’s the gist: Parents of teen and preteen kids, be on the lookout for odd little metallic canisters and their plastic dispensers. See these lying around, and be sure your kid is huffing the laughing gas. Kids who love to club, rave, or whatever they might be calling it now, are likely to be exposed (in balloons filled with “nitrous”). Talk to your kids about avoiding this junk; it’s not benign; it can mess them up big time. OK, I’ll get off the soapbox now. Good luck.

If It Seems Too Good To Be True

By On · Add Comment · In dopamine, drug, Modafinil, Provigil, side effects, sleep, smart drugs, stimulants
Wouldn’t it be great if there was a drug that could decrease the need for sleep, allow more time to work and study, and essentially make you smarter…without side effects? Well, if you remember my post on the subject last year, you’ll recall that that drug doesn’t exist. Oh, there are plenty of drugs that’ll keep you up and allow you to study harder–in the short term; but the one without side effects–dream on.

According to a recent study, the popular prescription stimulant, Provigil, has a higher risk of addiction than previously thought. Brain scans taken of people on the drug showed changes in the brain’s pleasure centers, which were similar to those occurring with the more frowned upon stimulants coke and meth. The study which is due for publication in this month’s Journal of the American Medical Association may break the myth that Provigil is safe for healthy people.

Provigil, or Modafinil, is known as a “smart drug” for its ability to keep people up for hours, thus making it popular with students and other academia (professors) in search of unlimited knowledge. Modafinil, however, is approved as a narcolepsy drug–that is, to fight off the daytime sleepiness associated with this disorder and obstructive sleep apnea. But why worry about that detail? Speed is speed is speed.

The “controversy” over smart drugs was brought to light last year when several scientists commented in the journal Nature that people should have the right to boost their brain power through the use of drugs like Provigil. At the time of that editorial it was thought that Provigil provided stimulation without side effects. This new study is the first evidence that Modafinil increases dopamine release–the “feel good” neurotransmitter implicated in most forms of addiction.

Well, as I’ve said time and time again, there’s no free lunch. You want to play you gotta pay. You can gain knowledge and be productive through hard work and study. But there’s simply no substitute for sleep. Sorry.

A Mournful Tragedy

By On · Add Comment · In Ambien, anaphylaxis, dead, drug, Heath Ledger, overdose, pneumonia, premature death, prescription, respiratory, sedative, side effects, sleeping, sleepng pills

Academy-award nominated actor Heath Ledger was found dead in his Manhattan apartment this afternoon, the apparent victim of a drug overdose. Although the exact cause of death is as of yet unknown, prescription sleeping pills were found strewn around his bed, recent reports disclose. Ledger apparently had some trouble sleeping recently and told the New York Times in November that he was taking Ambien. He also was reported to be suffering from pneumonia.

This a very sad and tragic story and my heart goes out to Heath Ledger’s family. Although there is no way, yet, to know what happened exactly, I wouldn’t be surprised if the combination of pneumonia (hacking, phlegmy congestion) and sleeping pills did him in. Ambien, in particular, can close off the airway and cause breathing difficulties. Add to that a sedative effect, and it may be a recipe for disaster. Ambien can also cause anaphylaxis–an acute and severe allergic reaction that can lead to death within minutes.

Let me say it loud and clear: Ambien is bad stuff! Don’t take it. I’ve reported the dangers of this drug extensively on the Dr. Nick Show (Episode 3–Lifestyle Drugs). It has side effects (read them here–this stuff is no joke). According to the Mayo clinic, you don’t want to take Ambien if you are suffering from respiratory conditions. Duh! YOU HAVE GOT TO READ THE LABELS! Period. Just because a drug is doctor prescribed doesn’t mean diddly. It’s everyone’s responsibility to know exactly what they are taking and what the dangers are at all times.

Google Ambien and pick an information site. Pick one–any one. The side effects are there. Don’t think it can’t happen to you. Heath Ledger was only 28 years old. He was young and vibrant and healthy. It could happen to anyone. Please, read the instructions, and if you’re not sure–don’t take it!

Rest in Peace Good Soul.

Heath Ledger 1979-2008.

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