The Associated Press is reporting the number of serious drug reactions and deaths reported to the government shot up in the first three months of this year, setting a record.

According to the report, the Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including reports of more than 4,800 deaths.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug’s problems were prompted by tainted heparin imported from China.

The other was Chantix, a new kind of anti-smoking drug from Pfizer.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said contaminated heparin was largely to blame.

The FDA and Congressional investigators are fighting over its refusal to release information on which Chinese companies supplied a tainted blood thinner that has led to at least 81 deaths in the United States.

Heparin is a widely used blood thinner, frequently given in large doses to patients in order to prevent clotting during complex medical procedures such as kidney dialysis or heart surgery.

Most of the heparin sold in the United States is manufactured from ingredients made in China, a major supplier of drug ingredients to the United States.

The FDA suspects that the deadly heparin originally became contaminated in a Chinese factory, but has refused to tell Congress which companies supplied heparin ingredients to the United States from China. The agency says that confidentiality agreements with the producers bar it from revealing any of their names.

The FDA claims that it does not have the legal authority to prevent the importation of Chinese-manufactured drugs, citing a Memorandum of Agreement that regulates relations between the FDA and China. The memorandum was signed in order to speed the process of allowing FDA inspection of Chinese drug factories in the first place.

Instead, the FDA is relying on companies to voluntarily test their heparin ingredients before distributing them in the United States. Yet such testing failed to reveal the tainted ingredient between January 2007 and February 2008.

Baxter, the country’s major manufacturer of the drug, has developed a new testing method that can distinguish between pure heparin and oversulfated chondroitin sulfate.

One of the plants that the FDA has inspected was Changzhou SPL, a supplier for Baxter. The factory is majority owned by Wisconsin-based Scientific Protein Laboratories Inc. (SPL), the world’s major supplier of heparin’s active ingredient.

At least 12 lawsuits have been filed against Baxter by patients and their family members who claim they were harmed by the tainted drug.

According to an Associated Press story, the families of two newborns who died after they were inadvertently given massive doses of heparin have sued an Indianapolis hospital and the Illinois-based company that makes the blood thinner.

The suit filed recently in Marion Superior Court against Methodist Hospital and Deerfield, Ill.-based Baxter Healthcare Corp. doesn’t specify damages.

The suit was filed by an defective drug attorney for the parents of two of the three newborns who died in September 2006 following injections of heparin 1,000 times greater than the recommended dose for infants. Also suing are the parents of two infants who were overdosed but survived.

The error occurred in part because of a mix up over labeling.

A Baxter spokeswoman said the deaths were tragic but preventable, and it is vital that clinicians always read the name and dose of a drug before giving it to a patient. Baxter changed the labeling on its heparin vials in October 2007.

A spokesman for Clarian Health Partners, of which Methodist is part, said the company did not have all the details of the litigation and had no comment.

Actor Dennis Quaid and his wife sued Baxter last year after their newborn twins got massive doses of the blood thinner at a hospital.

These families aren’t the only ones battling drug companies over wrongful deaths due to defective drugs or defective labeling. It is advisable to locate an experienced defective drug attorney in case legal advice is necessary for a heparin lawsuit or settlement .