Shortage of cyclosporine (modified) oral presentations

The American Society of Health-System Pharmacists reports a shortage of cyclosporine (modified) oral presentations. Chemically modified cyclosporine immediately forms an emulsion in water, making it more available to the body. It is more likely to be used to treat psoriasis and rheumatoid arthritis, while unmodified cyclosporine is more likely to be used to prevent rejection of kidney, heart, or liver transplants. Sandoz cites unspecified manufacturing delays as the cause of their shortage. Teva and Watson give no reason for their shortage.

Shortage of isradipine oral presentations

The American Society of Health-System Pharmacists reports a shortage of the oral presentations of isradipine. This drug shortage arises because the Novartis plant which produced extended-release isradipine, brand name Dynacirc CR, under contract with GlaxoSmithKline was voluntarily closed after it was discovered that packages of medications sometimes contained more than one kind of capsule or tablet. The extended-release tablet is taken once daily. The immediate-release capsule, taken twice daily, is available from Watson. Isradipine is used to treat high blood pressure, and there is some evidence that it might be usable to treat Parkinson's disease.

Shortage of injectable orphenadrine citrate

The American Society of Health-System Pharmacists reports a shortage of injectable orphenadrine citrate. This drug relaxes muscles and alleviates acute muscular-skeletal pain. It is in short supply because it is yet another drug whose production Bedford Laboratories contracted out to Ben Venue Labs. The latter voluntarily closed their facility. This drug actually has four US-approved manufacturers, but Akorn and Sagent did not provide a reason why their product is in short supply. Watson states that their product is back ordered because of production delays, with no further information as to the many possible reasons that delays occur.

The Life Cycle of a Drug: Authorized Generic

Referring to the bar graph in the first of this series of posts, the next most profitable strategy manufacturers can use in the life cycle of a drug is to authorize a generic version at the end of the patent life of a brand name drug. A current example is Pfizer's brand name drug, Lipitor (atorvastatin). As of last December 1st, Watson Pharmaceuticals has been authorized to sell a generic version of the drug for six months, as per current law. The Watson generic will be exactly the same as Lipitor and will be supplied to Watson by Pfizer, but will not bear the Pfizer logo or the Lipitor brand name. It is estimated that Pfizer will receive 70% of Watson's sales of the authorized generic atorvastatin.

Lipitor Patient Retention Plan

 As of this morning, there are three sources of atorvastatin approved for the US market - Pfizer's brand name drug Lipitor and generics from Watson Pharmaceuticals and Ranbaxy Laboratories. Pfizer has a strategy for maintaining its market share for the next six months that includes a patient co-payment card. See my earlier post on the rising popularity of this strategy, The Life Cycle of a Drug: Patient Retention. The card Pfizer is offering can be ordered at LipitorForYou.com, and allows its customers to pay only $4 of any co-payment up to a maximum of $50. Here is the link to Pfizer's FAQ for the co-payment card, including details of the terms and conditions of their offer. Pfizer's overall goal is to sell Lipitor at or below generic prices until May 2012.

Pfizer is also using a new strategy involving contracts with UnitedHealthcare, Coventry Health Care, Express Scripts, Medco Health Solutions, CVS/Caremark and Catalyst Rx, which substitute Pfizer's brand name Lipitor for generic atorvastatin. It is clear that these contracts contain discounts that allow the profitable sale of Lipitor at reduced prices. The other terms of the contracts are unavailable to the public. Since it is unclear whether private and public insurers will be charged the discounted price or some other, higher price, the Federal Trade Commission has begun an investigation and Senator Herb Kohl, Chair of the US Senate Special Committee on Aging, has requested information on the contracts in letters cosigned by Senators Max Baucus and Charles Grassley.

Shortage of Tetracycline Capsules

The American Society of Health-System Pharmacists reports a shortage of tetracycline hydrochloride capsules from Teva Pharmaceuticals and Watson Pharma. The current FDA-approved information regarding this drug is provided on the Watson website. (UPDATED LINK) Perhaps you have been discouraged from reading documents like this by the small print or the technical nature of the information provided. Your doctor can help with the latter, but I am taking this opportunity to point out that enlarging the text to 200% or greater in a PDF reader is a big help for readability. You could do this on a copier as well.

Since I routinely look for this kind of information on-line as part of my business activities, one of the first things I do is go to the end of the document and see when it was produced. In this case you can see that it was last revised in July 2011. Prominently displayed above the date is where the drug is manufactured (India) and where it is distributed (US). This information can be useful if you have heard of manufacturing problems at a particular location, or want to find out whether there are any.

There are probably quite a few people who are aware that tetracycline can discolor your teeth, and detailed information about that can be found under CONTRAINDICATIONS, p. 1, column 2, paragraphs 2 and 3. The first line in this section contains useful information, but is also an example of how the information presented is not so straightforward. The tetracyclines are a group of antibiotics, of which tetracycline is the founding member. If you are hypersensitive, i.e., allergic, to one member of the group, you are going to be hypersensitive to all of them. I hasten to add that this is not true of all drug groupings, so you can't generalize.

Now look further up the same column at INDICATIONS AND USAGE. In previous posts I explained what an indication is in the medical sense of the word, and explained off-label use. In this section of the document you will find the list of what the FDA considers valid reasons to use tetracycline hydrochloride capsules. Any other use is an off-label use, by definition. Please recall from my previous post that there are sometimes good reasons for off-label use of a drug.

Still in INDICATIONS AND USAGE, the first line, notice the words "susceptible strains" and the subheading Susceptibility Testing at the top of the column, where there is a technical explanation of how a susceptible strain is defined in this case. There have been many reports of antibiotic-resistant strains in the media, and there are many that are resistant to tetracycline. So many, in fact, that I personally would not take this drug unless the prescribing doctor was first willing to send a sample of whatever was infecting me to the lab for an antibiotic-sensitivity test. (Antibiotic susceptibility and sensitivity are the same thing.) If you read on through the CONTRAINDICATIONS section, you can see that there are valid reasons not to take this antibiotic, and you are going to need professional help in order to know whether any apply to you.