Showing posts with label Ben Venue Labs. Show all posts
Showing posts with label Ben Venue Labs. Show all posts

Tuesday, June 26, 2012

Shortage of injectable dobutamine

The American Society of Health-System Pharmacists reports a shortage of injectable dobutamine. This drug increases the force with which the heart muscle contracts, making it possible for the heart to pump more blood without having to increase the rate at which it contracts. In other words, your pulse stays the same. WARNING: This is true for about 90% of the people given dobutamine. The other 10% may have both increased heart rate and blood pressure. Since dobutamine works on beta-receptors in the muscle, it is ineffective if you have recently taken a beta-blocker.

This is yet another shortage caused by Ben Venue's voluntary closure of its manufacturing facility, where it manufactured this drug on contract for Bedford Laboratories. There are two remaining manufacturers - Hospira cites unspecified manufacturing delays and Baxter does not give a reason for its shortage.

Dobutamine is used after heart surgery to help the heart recover, and is also given to people with heart failure to help keep blood flowing as well as possible.

Monday, April 30, 2012

Shortage of perflutren lipid microspheres

The American Society of Health-System Pharmacists reports a shortage of perflutren lipid microspheres. This drug, brand name Definity, is perflutren gas enclosed in microspheres made of phosphatidylcholine and egg albumen. It is sometimes administered intravenously to improve the ability to see details when performing an ultrasound of the left ventricle of the heart (echocardiogram). There are excellent reasons not to use Definity at all, as given in this FDA notice. Lantheus cites manufacturing delays as the reason for the shortage and states that Ben Venue makes this product for them on contract. This leads to speculation that this shortage is one of many caused by the voluntary shutdown of a Ben Venue plant some months ago.

There is a similar product, Optison, made by GE which contains human albumen. Obviously this is good for people who are known to be allergic to egg proteins, but it is also bad in that human blood products such as albumen may spread viral diseases such as HIV. The ASHP provides a detailed comparison of the two products in this table. Also note the updated warnings added to the information sheet for Definity. The 2008 warnings in the FDA notice above apply to Optison as well.

Wednesday, March 7, 2012

Shortage of injectable enalaprilat

The American Society of Health-System Pharmacists reports a shortage of injectable enalaprilat. This drug shortage is yet another that arises from the voluntary closure of Ben Venue's manufacturing facility, where injectable enalaprilat was produced under contract for Bedford Laboratories. There is no mention of why Hospira's product is in short supply. This drug will injure and possibly kill a developing fetus. When medication cannot be taken by mouth, this is an injectable option for control of high blood pressure. It is an angiotension I-converting-enzyme inhibitor (ACEI).

Thursday, February 16, 2012

Shortage of injectable amphotericin B cholesteryl sulfate complex

The American Society of Health-System Pharmacists reports a shortage of injectable amphotericin B cholesteryl sulfate complex. Alkopharma purchased this drug, brand name Amphotec, and contracted its manufacture to Ben Venue Laboratories. This shortage arises from the voluntary closure of Ben Venue's facility. This drug is very important to chronically ill people or people whose immune system is not functioning well due to disease or drugs. Such patients often suffer from very serious fungal infections, but cannot tolerate the  damage caused by amphotericin B deoxycholate, the form usually administered first. Amphotericin B is effective against fungi because of its action on components of their membranes. Unfortunately, humans have the same membrane components, so toxicity to human cells is a problem that is partially alleviated by using Amphotec. Because Amphotec is a complex in which the drug is enclosed in a liposome, it is much better tolerated by the kidneys than amphotericin B deoxycholate.

Tuesday, February 7, 2012

Shotage of injectable bumetanide

The American Society of Health-System Pharmacists reports a shortage of injectable bumetanide. When a person swells up with a lot of extra water in their body due to heart failure or liver or kidney disease, bumetanide is an option that can be used to stimulate the kidneys and get rid of some of the water. This is yet another drug shortage caused by the voluntary shutdown of Ben Venue's manufacturing facility, where it was made under contract for Bedford Laboratories. Bumetanide belongs to a drug class called diuretics. When someone is allergic to the widely-used diuretic, furosemide, bumetanide is an important alternative because most people are not allergic to both of them, even though they have some chemical similarities.

Bumetanide is a very strong diuretic and must be carefully used to avoid loss of too much water and too many important minerals along with it.

Friday, February 3, 2012

Shortage of injectable ketamine

The American Society of Health-System Pharmacists reports a shortage of injectable ketamine. This is yet another drug which was manufactured by Ben Venue under contract for Bedford Laboratories. The voluntary shutdown of Ben Venue's facility was probably the cause of this shortage. JHF manufactures a brand name version of this drug, Ketalar, and cites increased demand as the reason for their shortage. Hospira cites manufacturing delays and Mylan does not give a reason. I recommend reading Ketamine: A Brief History in the article referenced below. An off-label use of ketamine is currently being investigated. By a yet unknown mechanism involving the brain's glutamate metabolism, the drug relieves suicidal depression within hours. Relief of the depressive phase of bipolar disorder and of treatment-resistant depression is also under investigation.

Lankenau, S. E. and M. C. Clatts. Ketamine Injection among High Risk Youth: Preliminary Findings from New York City. J Drug Issues 32(3):893-905, 2002.

Friday, January 27, 2012

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.

Thursday, January 26, 2012

Shortage of injectable vinblastine

The American Society of Health-System Pharmacists reports a shortage of injectable vinblastine. See the ASHP link for the patients who might be affected by this drug shortage. Note that a number of cancers are treated with vinblastine, and there is no direct substitute. There is now a sole US-approved manufacturer after Ben Venue voluntarily shut the facility at which it manufactured the drug under contract for Bedford Laboratories. 

A flowchart from ASHP Guidelines on Managing Drug Shortages in Hospitals and Health Systems is reproduced below.

Am J Health-Syst Pharm 66:1402 (2009)

Tuesday, January 17, 2012

Shortage of injectable doxapram

The American Society of Health-System Pharmacists reports a shortage of injectable doxapram, which stimulates breathing. The generic version of this drug is unavailable because it was one of the many manufactured by Ben Venue Labs under contract for Bedford Laboratories. Readers of my previous posts are aware by now that Ben Venue Labs voluntarily closed their manufacturing facility. Dopram, the brand name version of the drug manufactured by West-Ward, is in short supply. This drug is an important tool of anesthesiologists when people are not breathing well after surgery. In emergency rooms, it is likewise important in dealing with drug overdoses that depress respiration.

Wednesday, January 11, 2012

Shortage of injectable pentostatin

The American Society of Health-System Pharmacists reports a shortage of injectable pentostatin. This is yet another drug shortage due to the voluntary closure of Ben Venue Labs, which manufactured this and other products under contract for Bedford Laboratories. This drug is used for treatment of a particular type of cancer known as hairy cell leukemia for the hair-like projections on the abnormal cells. In this type of leukemia, too many of the cells in the bone marrow develop into lymphocytes, at the expense of other types of blood cells. Fortunately this cancer is rare and there are treatment options, summarized here by the Hairy Cell Leukemia Research Foundation.

Monday, January 9, 2012

Shortage of injectable atracurium

The American Society of Health-System Pharmacists has reported a shortage of injectable atracurium. This shortage is a result of the voluntary shutdown of Ben Venue Labs, a contract manufacturing company. In this instance they were the only manufacturer of injectable atracurium under contract with Bedford Laboratories. This and other members of this group prevent the skeletal muscles of the body from contracting and interfering during surgery and when inserting a tube down the windpipe to assist breathing. Shortages increase the chance of dosing errors because the various members of the group have varying durations of their effects.

Friday, December 2, 2011

Shortage of injectable dexrazoxane

The American Society of Health-System Pharmacists reports a shortage of injectable dexrazoxane. After a woman has received a total of 300 mg/square meter body surface area of doxirubicin for her breast cancer, dexrazoxane is added to the treatment in order to protect her heart from the damage that is a side effect of doxirubicin. Zinecard, the Pfizer brand of this drug, has been in short supply because the sodium lactate they provided to dissolve the dexrazoxane contained particulate matter. In a June 7, 2011 letter (PDF) to health care providers, Pfizer presented their solution to this problem, an alternate procedure for first dissolving Zinecard in sterile water for injection and then in lactated Ringer's solution. On November 19, 2011, however, the Bedford Labs generic version manufactured at Ben Venue Labs became unavailable because of the voluntary shutdown of that facility for equipment maintenance and requalification.

The newly approved dilution procedure for Zinecard gives rise to a possible source of confusion and error, because the Mylan and Bedford generic dexrazoxane is only approved to be dissolved in the sodium lactate solution provided with them.